Trial Outcomes & Findings for Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis (NCT NCT03233529)
NCT ID: NCT03233529
Last Updated: 2019-08-13
Results Overview
CCL18 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline (Day 1), Day 15
Results posted on
2019-08-13
Participant Flow
Participant milestones
| Measure |
Crisaborole Ointment 2%+Vehicle, Then Crisaborole Ointment 2%
The study consisted of 2 periods, i.e., a double-blind period from Day 1 to Day 15 skin biopsy collection, and an open-label period from Day 15 skin biopsy collection to the end of study (Day 71). Each participant received double-blind topical administration of crisaborole ointment 2 percent (%) for 1 target lesion and placebo ointment vehicle (referred to as vehicle) for the other target lesion (i.e., each participant was treated with both crisaborole and vehicle), twice daily from Day 1 to Day 14; then received open-label topical administration of crisaborole ointment 2% for all atopic dermatitis skin areas (excluding scalp) twice daily from Day 15 to Day 42.
|
|---|---|
|
Double-Blind Period (Day 1 to Day 15)
STARTED
|
40
|
|
Double-Blind Period (Day 1 to Day 15)
COMPLETED
|
39
|
|
Double-Blind Period (Day 1 to Day 15)
NOT COMPLETED
|
1
|
|
Open-Label Period (Day 15 to Day 71)
STARTED
|
39
|
|
Open-Label Period (Day 15 to Day 71)
COMPLETED
|
38
|
|
Open-Label Period (Day 15 to Day 71)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Crisaborole Ointment 2%+Vehicle, Then Crisaborole Ointment 2%
The study consisted of 2 periods, i.e., a double-blind period from Day 1 to Day 15 skin biopsy collection, and an open-label period from Day 15 skin biopsy collection to the end of study (Day 71). Each participant received double-blind topical administration of crisaborole ointment 2 percent (%) for 1 target lesion and placebo ointment vehicle (referred to as vehicle) for the other target lesion (i.e., each participant was treated with both crisaborole and vehicle), twice daily from Day 1 to Day 14; then received open-label topical administration of crisaborole ointment 2% for all atopic dermatitis skin areas (excluding scalp) twice daily from Day 15 to Day 42.
|
|---|---|
|
Double-Blind Period (Day 1 to Day 15)
Adverse Event
|
1
|
|
Open-Label Period (Day 15 to Day 71)
Adverse Event
|
1
|
Baseline Characteristics
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Crisaborole Ointment 2%+Vehicle, Then Crisaborole Ointment 2%
n=40 Participants
The study consisted of 2 periods, i.e., a double-blind period from Day 1 to Day 15 skin biopsy collection, and an open-label period from Day 15 skin biopsy collection to the end of study (Day 71). Each participant received double-blind topical administration of crisaborole ointment 2 percent (%) for 1 target lesion and placebo ointment vehicle (referred to as vehicle) for the other target lesion (i.e., each participant was treated with both crisaborole and vehicle), twice daily from Day 1 to Day 14; then received open-label topical administration of crisaborole ointment 2% for all atopic dermatitis skin areas (excluding scalp) twice daily from Day 15 to Day 42.
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|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 11.29 • n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product and had TSS assessment at Day 15.
The lesion TSS is an assessment of target lesion severity based on the severity of the following 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each of which was rated on a scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). These 4 ratings were then added to create the TSS, which ranges from 0 (none) to 12 (most severe), with higher score representing greater severity.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Lesion Total Sign Score (TSS) for Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
-2.1 units on a scale
Standard Error 0.35
|
-4.5 units on a scale
Standard Error 0.31
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
CCL17 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by Taqman low density array (TLDA) reverse-transcriptase (RT) polymerase chain reaction (PCR) were normalized to the housekeeping gene ribosomal protein lateral stalk subunit P0 (RPLP0) and log2-transformed prior to analysis.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Key Skin Biomarker Chemokine Ligand (CCL)17 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
-0.2881 log2(normalized expression)
Standard Error 0.34055
|
-1.2787 log2(normalized expression)
Standard Error 0.36339
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
CCL18 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Key Skin Biomarker CCL18 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
-0.1849 log2(normalized expression)
Standard Error 0.25272
|
-0.7295 log2(normalized expression)
Standard Error 0.25784
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
CCL22 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Key Skin Biomarker CCL22 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
-0.1994 log2(normalized expression)
Standard Error 0.22335
|
-1.3267 log2(normalized expression)
Standard Error 0.24359
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
IL-13 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Key Skin Biomarker Interleukin (IL)-13 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
0.2128 log2(normalized expression)
Standard Error 0.27893
|
-0.5484 log2(normalized expression)
Standard Error 0.25767
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
KRT16 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Key Skin Biomarker Keratin 16 (KRT16) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
-1.0854 log2(normalized expression)
Standard Error 0.33131
|
-2.4495 log2(normalized expression)
Standard Error 0.30229
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
Elafin/PI3 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Key Skin Biomarker Elafin/Peptidase Inhibitor 3 (PI3) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
-1.2989 log2(normalized expression)
Standard Error 0.35218
|
-2.4235 log2(normalized expression)
Standard Error 0.33463
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
S100A12 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
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|---|---|---|
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Change From Baseline in Key Skin Biomarker S100 Calcium Binding Protein A12 (S100A12) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
-1.2849 log2(normalized expression)
Standard Error 0.40613
|
-3.2762 log2(normalized expression)
Standard Error 0.39686
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
Epidermal thickness was one of the other skin biomarkers of atopic dermatitis and was studied using immunohistochemistry (IHC). Expression data were log2-transformed.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Expression of Other Skin Biomarker (Epidermal Thickness) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
|
-0.1779 log2-scale micrometers
Standard Error 0.08229
|
-0.2737 log2-scale micrometers
Standard Error 0.10653
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
CD11c+ dendritic cells (DCs), CD3+ T cells, FcEpsilon + DCs, Ki 67+ cells, and langerin+ cells (for langerhans cells) were studied using IHC. These parameters were referred to as CD11c, CD3, FceR1, Ki67, langerin, respectively, in the outcome measure title above and data table below. Expression data were log2-transformed.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Expression of Other Skin Biomarkers (CD11c, CD3, FceR1, Ki67, Langerin) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CD11c
|
-0.1694 log2-scale cells per square millimeter
Standard Error 0.11081
|
-0.4736 log2-scale cells per square millimeter
Standard Error 0.18946
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CD11c, CD3, FceR1, Ki67, Langerin) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CD3
|
-0.2642 log2-scale cells per square millimeter
Standard Error 0.13959
|
-0.6219 log2-scale cells per square millimeter
Standard Error 0.15152
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CD11c, CD3, FceR1, Ki67, Langerin) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
FceR1
|
-0.1314 log2-scale cells per square millimeter
Standard Error 0.16513
|
-0.4226 log2-scale cells per square millimeter
Standard Error 0.16068
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CD11c, CD3, FceR1, Ki67, Langerin) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
Ki67
|
-0.8971 log2-scale cells per square millimeter
Standard Error 0.19918
|
-1.0983 log2-scale cells per square millimeter
Standard Error 0.21512
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CD11c, CD3, FceR1, Ki67, Langerin) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
Langerin
|
0.2779 log2-scale cells per square millimeter
Standard Error 0.19645
|
0.3694 log2-scale cells per square millimeter
Standard Error 0.27896
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
TLDA RT PCR was used to analyze the following other skin biomarkers: CCL13, CCL20, CCL26, CRLF2, CXCL1, CXCL2, CXCL9, CXCL10, DEFB4A, filaggrin (FLG), FOXP3, IFNG, IL-1B, IL-2, IL-2RA, IL-5, IL-6, IL-8, IL-9, IL-10, IL-12A, IL-15, IL-15RA, IL-17A, IL-17F, IL-19, IL-22, IL-23A, IL-31, IL-32, LOR, MMP-12, PDE4A, PDE4B, PDE4D, PPL, RNA18SP5, S100A7, S100A8, and S100A9. Expression levels were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
DEFB4A
|
-1.3456 log2(normalized expression)
Standard Error 0.46988
|
-3.5331 log2(normalized expression)
Standard Error 0.42635
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-15
|
0.2193 log2(normalized expression)
Standard Error 0.11761
|
-0.2307 log2(normalized expression)
Standard Error 0.12331
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-2RA
|
-0.0824 log2(normalized expression)
Standard Error 0.22176
|
-0.8836 log2(normalized expression)
Standard Error 0.19462
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
PDE4D
|
0.0736 log2(normalized expression)
Standard Error 0.12231
|
-0.3865 log2(normalized expression)
Standard Error 0.12920
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
S100A7
|
-0.8782 log2(normalized expression)
Standard Error 0.26498
|
-2.1764 log2(normalized expression)
Standard Error 0.30729
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CXCL9
|
0.7562 log2(normalized expression)
Standard Error 0.39811
|
-0.9941 log2(normalized expression)
Standard Error 0.33692
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CCL13
|
0.0604 log2(normalized expression)
Standard Error 0.20967
|
-0.3095 log2(normalized expression)
Standard Error 0.21520
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CCL20
|
0.1088 log2(normalized expression)
Standard Error 0.23212
|
-0.2016 log2(normalized expression)
Standard Error 0.23629
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CCL26
|
0.1195 log2(normalized expression)
Standard Error 0.22820
|
0.0231 log2(normalized expression)
Standard Error 0.18602
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CRLF2
|
-0.2023 log2(normalized expression)
Standard Error 0.14431
|
-0.8058 log2(normalized expression)
Standard Error 0.13728
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CXCL1
|
0.1924 log2(normalized expression)
Standard Error 0.32423
|
-1.4174 log2(normalized expression)
Standard Error 0.23956
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CXCL10
|
0.6697 log2(normalized expression)
Standard Error 0.37822
|
-1.0779 log2(normalized expression)
Standard Error 0.36531
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
CXCL2
|
0.1945 log2(normalized expression)
Standard Error 0.20700
|
-0.5462 log2(normalized expression)
Standard Error 0.21129
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
FLG
|
-0.3670 log2(normalized expression)
Standard Error 0.22285
|
-0.2155 log2(normalized expression)
Standard Error 0.18503
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
FOXP3
|
-0.0273 log2(normalized expression)
Standard Error 0.16057
|
-0.5115 log2(normalized expression)
Standard Error 0.12709
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IFNG
|
0.5737 log2(normalized expression)
Standard Error 0.31138
|
-0.5588 log2(normalized expression)
Standard Error 0.34472
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-10
|
0.2950 log2(normalized expression)
Standard Error 0.17314
|
-0.3773 log2(normalized expression)
Standard Error 0.19458
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-15RA
|
0.2110 log2(normalized expression)
Standard Error 0.10624
|
-0.0780 log2(normalized expression)
Standard Error 0.10814
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-17A
|
0.7516 log2(normalized expression)
Standard Error 0.59970
|
-1.1577 log2(normalized expression)
Standard Error 0.57223
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-17F
|
0.5309 log2(normalized expression)
Standard Error 0.88038
|
-1.9482 log2(normalized expression)
Standard Error 0.79294
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-19
|
-0.8108 log2(normalized expression)
Standard Error 0.75460
|
-3.1946 log2(normalized expression)
Standard Error 0.78012
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-1B
|
0.2808 log2(normalized expression)
Standard Error 0.29124
|
-0.5792 log2(normalized expression)
Standard Error 0.21864
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-2
|
0.2769 log2(normalized expression)
Standard Error 0.16896
|
-0.5352 log2(normalized expression)
Standard Error 0.26229
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-22
|
-0.0170 log2(normalized expression)
Standard Error 0.35503
|
-1.4970 log2(normalized expression)
Standard Error 0.39951
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-31
|
-0.3997 log2(normalized expression)
Standard Error 0.65363
|
-1.5885 log2(normalized expression)
Standard Error 0.60512
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-32
|
0.1878 log2(normalized expression)
Standard Error 0.15632
|
-0.2992 log2(normalized expression)
Standard Error 0.16762
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-5
|
-0.4148 log2(normalized expression)
Standard Error 0.42311
|
-0.3487 log2(normalized expression)
Standard Error 0.51329
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-6
|
0.1724 log2(normalized expression)
Standard Error 0.36369
|
-0.8814 log2(normalized expression)
Standard Error 0.32670
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-8
|
-0.1698 log2(normalized expression)
Standard Error 0.42603
|
-1.9805 log2(normalized expression)
Standard Error 0.37922
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-9
|
-1.0530 log2(normalized expression)
Standard Error 0.68305
|
-2.2803 log2(normalized expression)
Standard Error 0.71683
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-12A
|
0.5251 log2(normalized expression)
Standard Error 0.16751
|
0.2787 log2(normalized expression)
Standard Error 0.20557
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
IL-23A
|
-0.1173 log2(normalized expression)
Standard Error 0.28133
|
-1.2754 log2(normalized expression)
Standard Error 0.26058
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
LOR
|
-0.1041 log2(normalized expression)
Standard Error 0.21965
|
0.3759 log2(normalized expression)
Standard Error 0.19707
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
MMP-12
|
-0.4205 log2(normalized expression)
Standard Error 0.34033
|
-1.9588 log2(normalized expression)
Standard Error 0.39817
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
PDE4A
|
0.1359 log2(normalized expression)
Standard Error 0.11153
|
0.0105 log2(normalized expression)
Standard Error 0.12015
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
PDE4B
|
0.1923 log2(normalized expression)
Standard Error 0.10897
|
-0.1900 log2(normalized expression)
Standard Error 0.12061
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
PPL
|
-0.1933 log2(normalized expression)
Standard Error 0.12180
|
-0.3000 log2(normalized expression)
Standard Error 0.09781
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
RNA18SP5
|
-0.0221 log2(normalized expression)
Standard Error 0.06550
|
0.1121 log2(normalized expression)
Standard Error 0.08576
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
S100A8
|
-1.0669 log2(normalized expression)
Standard Error 0.33255
|
-2.4454 log2(normalized expression)
Standard Error 0.36057
|
|
Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15
S100A9
|
-1.2976 log2(normalized expression)
Standard Error 0.33324
|
-2.6155 log2(normalized expression)
Standard Error 0.35209
|
SECONDARY outcome
Timeframe: Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
FLG expression was studied using IHC and categorized as no change, partial normalization, full normalization, or worsening by a blinded expert pathologist based on visual scoring.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Number of Participants With Categorical Filaggrin (FLG) Expression at Day 15
No change
|
19 Participants
|
10 Participants
|
|
Number of Participants With Categorical Filaggrin (FLG) Expression at Day 15
Partial normalization
|
5 Participants
|
10 Participants
|
|
Number of Participants With Categorical Filaggrin (FLG) Expression at Day 15
Full normalization
|
4 Participants
|
12 Participants
|
|
Number of Participants With Categorical Filaggrin (FLG) Expression at Day 15
Worsening
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
Histological response was studied using IHC and categorized as non-responder or responder by a blinded expert pathologist based on a global assessment of all thickness, KRT16 and FLG stains.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Number of Participants With Categorical Histological Response at Day 15
Non-responder
|
30 Participants
|
18 Participants
|
|
Number of Participants With Categorical Histological Response at Day 15
Responder
|
9 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.
KRT16 expression was studied using IHC and categorized as no change, slight improvement, good improvement, excellent improvement, or worsening by a blinded expert pathologist based on visual scoring.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Number of Participants With Categorical KRT16 Expression at Day 15
No change
|
18 Participants
|
13 Participants
|
|
Number of Participants With Categorical KRT16 Expression at Day 15
Slight improvement
|
10 Participants
|
3 Participants
|
|
Number of Participants With Categorical KRT16 Expression at Day 15
Good improvement
|
5 Participants
|
8 Participants
|
|
Number of Participants With Categorical KRT16 Expression at Day 15
Excellent improvement
|
1 Participants
|
12 Participants
|
|
Number of Participants With Categorical KRT16 Expression at Day 15
Worsening
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 8Population: All randomized participants who received at least 1 dose of investigational product.
The lesion TSS is an assessment of target lesion severity based on the severity of the following 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each of which was rated on a scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). These 4 ratings were then added to create the TSS, which ranges from 0 (none) to 12 (most severe), with higher score representing greater severity.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Lesion Severity as Measured by TSS at Day 8
|
-1.2 units on a scale
Standard Error 0.27
|
-3.3 units on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 8 and 15Population: "Number of Participants Analyzed" signifies the number of participants who received at least 1 dose of investigational product. "Number Analyzed" refers to the number of evaluable participants for specified time points.
The lesion ISGA is an assessment of target lesion severity of atopic dermatitis. The lesion ISGA score ranges from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe), with higher score representing greater severity.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Lesion Severity as Measured by Investigator Static Global Assessment (ISGA) at Day 8 and Day 15
Day 8
|
-0.4 units on a scale
Standard Error 0.11
|
-1.3 units on a scale
Standard Error 0.16
|
|
Change From Baseline in Lesion Severity as Measured by Investigator Static Global Assessment (ISGA) at Day 8 and Day 15
Day 15
|
-0.8 units on a scale
Standard Error 0.16
|
-1.9 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15Population: "Number of Participants Analyzed" signifies the number of participants who received at least 1 dose of investigational product. "Number Analyzed" refers to the number of evaluable participants for specified time points.
The intensity of pruritus was assessed by an NRS, which was a numeric rating scale ranging from 0 (no itching) to 10 (worst imaginable itching), with higher score indicating greater severity.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 2
|
-1.0 units on a scale
Standard Error 0.31
|
-1.9 units on a scale
Standard Error 0.36
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 3
|
-0.9 units on a scale
Standard Error 0.38
|
-2.2 units on a scale
Standard Error 0.36
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 4
|
-1.1 units on a scale
Standard Error 0.33
|
-2.4 units on a scale
Standard Error 0.33
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 5
|
-1.1 units on a scale
Standard Error 0.36
|
-2.7 units on a scale
Standard Error 0.31
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 6
|
-1.3 units on a scale
Standard Error 0.36
|
-2.6 units on a scale
Standard Error 0.34
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 7
|
-1.5 units on a scale
Standard Error 0.35
|
-3.1 units on a scale
Standard Error 0.36
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 8
|
-1.5 units on a scale
Standard Error 0.33
|
-3.4 units on a scale
Standard Error 0.35
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 9
|
-1.5 units on a scale
Standard Error 0.34
|
-3.4 units on a scale
Standard Error 0.32
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 10
|
-1.6 units on a scale
Standard Error 0.32
|
-3.5 units on a scale
Standard Error 0.34
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 11
|
-2.0 units on a scale
Standard Error 0.41
|
-3.5 units on a scale
Standard Error 0.41
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 12
|
-1.5 units on a scale
Standard Error 0.36
|
-3.7 units on a scale
Standard Error 0.40
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 13
|
-2.2 units on a scale
Standard Error 0.39
|
-4.0 units on a scale
Standard Error 0.38
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 14
|
-2.2 units on a scale
Standard Error 0.37
|
-3.9 units on a scale
Standard Error 0.36
|
|
Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15
Day 15
|
-2.0 units on a scale
Standard Error 0.41
|
-3.9 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: From first dose of study treatment up to Day 71Population: All participants in each treatment group who received at least 1 dose of investigational product.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of study treatment. Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see next Outcome Measure).
Outcome measures
| Measure |
Vehicle Treated Lesion
n=39 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) by Treatment Groups
Treatment-emergent AEs
|
16 Participants
|
27 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) by Treatment Groups
Treatment-emergent SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (on Day 1) to Day 15 skin biopsy collectionPopulation: This outcome measure was summarized by the treatment areas during the double-blind period; therefore, the analysis population here represents the participants who received at least 1 dose of investigational product for each treatment area in double-blind period.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of study treatment. During double-blind period, there were a total of 2 treatment areas (for target lesions) for each participant. For this outcome measure, treatment-emergent AEs occurred at each treated area during double-blind period were summarized. MedDRA version 21.0 coding dictionary was used.
Outcome measures
| Measure |
Vehicle Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the other target lesions that were treated with vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% Treated Lesion
n=40 Participants
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the target lesions that were treated with crisaborole ointment 2% during Days 1 to 14.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period
Application site dermatitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period
Application site erythema
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period
Application site pain
|
4 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period
Application site pruritus
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period
Application site folliculitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period
Post procedural haemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period
Procedural pain
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period
Suture related complication
|
2 Participants
|
1 Participants
|
Adverse Events
Crisaborole Ointment 2% + Vehicle in Double-Blind Period
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Crisaborole Ointment 2% in Open-Label Period
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crisaborole Ointment 2% + Vehicle in Double-Blind Period
n=40 participants at risk
On Days 1 to 14, for each participant, one target lesion was treated with crisaborole ointment 2% and the other target lesion was treated with vehicle, i.e., each participant was treated with both crisaborole and vehicle. This reporting group represents the participants who were treated with both crisaborole ointment 2% and vehicle during Days 1 to 14.
|
Crisaborole Ointment 2% in Open-Label Period
n=39 participants at risk
On Days 15 to 42, each participant received crisaborole ointment 2% for all atopic dermatitis skin areas (excluding scalp).
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|---|---|---|
|
General disorders
Application site pain
|
10.0%
4/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
10.3%
4/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
5.1%
2/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Infections and infestations
Nasopharyngitis
|
17.5%
7/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
12.8%
5/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
15.0%
6/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Injury, poisoning and procedural complications
Suture related complication
|
10.0%
4/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
5.1%
2/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Nervous system disorders
Headache
|
20.0%
8/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
12.8%
5/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Eye disorders
Noninfective conjunctivitis
|
0.00%
0/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
General disorders
Application site dermatitis
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
General disorders
Application site erythema
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
General disorders
Application site paraesthesia
|
0.00%
0/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
General disorders
Application site pruritus
|
5.0%
2/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
General disorders
Fatigue
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
General disorders
Injection site pain
|
0.00%
0/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Infections and infestations
Application site folliculitis
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Infections and infestations
Cystitis
|
0.00%
0/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Infections and infestations
Paronychia
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
2.6%
1/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Nervous system disorders
Burning sensation
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Nervous system disorders
Paraesthesia
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Nervous system disorders
Presyncope
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
2/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
2.5%
1/40 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
0.00%
0/39 • From first dose of study treatment up to Day 71
Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see Outcome Measure 19 for the treated area AEs).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER