Trial Outcomes & Findings for Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis. (NCT NCT03725722)
NCT ID: NCT03725722
Last Updated: 2025-03-12
Results Overview
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition. The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Mixed Model for Repeated Measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib doses and delgocitinib cream vehicle.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
251 participants
Primary outcome timeframe
Week 0 to Week 8
Results posted on
2025-03-12
Participant Flow
251 participants from 31 sites in 3 countries (U.S., Canada and Australia) were randomised in this trial. The first participant was screened on 29-Nov-2018 and the last participant completed the trial on 19-May-2020.
326 participants were screened for this trial. Of these, 75 participants (23.0%) were screening failures. The main reason for screening failure was failure to meet eligibility criteria (18.4%).
Participant milestones
| Measure |
Delgocitinib Cream 1 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
50
|
52
|
50
|
|
Overall Study
COMPLETED
|
38
|
44
|
44
|
46
|
36
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
6
|
6
|
14
|
Reasons for withdrawal
| Measure |
Delgocitinib Cream 1 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
2
|
0
|
2
|
|
Overall Study
Adverse Event
|
2
|
2
|
1
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
0
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
2
|
2
|
1
|
|
Overall Study
Personal reasons
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
COVID-19 situation
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.
Baseline characteristics by cohort
| Measure |
Delgocitinib Cream 1 mg/g
n=49 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
n=50 Participants
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 16.1 • n=99 Participants
|
38.5 years
STANDARD_DEVIATION 16.6 • n=107 Participants
|
42.0 years
STANDARD_DEVIATION 17.4 • n=206 Participants
|
37.4 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 19.6 • n=31 Participants
|
40.5 years
STANDARD_DEVIATION 17.0 • n=30 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
172 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
79 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
25 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
226 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
132 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
31 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
69 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
15 participants
n=7 Participants
|
14 participants
n=31 Participants
|
72 participants
n=30 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
29 participants
n=107 Participants
|
19 participants
n=206 Participants
|
24 participants
n=7 Participants
|
25 participants
n=31 Participants
|
120 participants
n=30 Participants
|
|
Region of Enrollment
Australia
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
13 participants
n=7 Participants
|
11 participants
n=31 Participants
|
59 participants
n=30 Participants
|
|
Baseline EASI score
|
9.3 units on a scale
STANDARD_DEVIATION 5.2 • n=99 Participants
|
10.9 units on a scale
STANDARD_DEVIATION 9.1 • n=107 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 4.6 • n=206 Participants
|
9.9 units on a scale
STANDARD_DEVIATION 6.9 • n=7 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 7.3 • n=31 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 6.8 • n=30 Participants
|
|
Baseline vIGA-AD score
0 - Clear
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Baseline vIGA-AD score
1 - Almost clear
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Baseline vIGA-AD score
2 - Mild
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
90 Participants
n=30 Participants
|
|
Baseline vIGA-AD score
3 - Moderate
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
140 Participants
n=30 Participants
|
|
Baseline vIGA-AD score
4 - Severe
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 8Population: FAS (defined as all randomized subjects exposed to investigational medicinal product)
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition. The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Mixed Model for Repeated Measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib doses and delgocitinib cream vehicle.
Outcome measures
| Measure |
Delgocitinib Cream 1 mg/g
n=49 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
n=51 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
n=50 Participants
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.
|
-5.0 score on a scale
Standard Error 0.7
|
-4.9 score on a scale
Standard Error 0.7
|
-5.8 score on a scale
Standard Error 0.7
|
-7.6 score on a scale
Standard Error 0.7
|
-1.9 score on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Week 0 to Week 8Population: FAS (defined as all randomized subjects exposed to investigational medicinal product).
vIGA-AD is an instrument used in clinical trials to assess the subject's global disease severity and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose-selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and the delgocitinib cream vehicle.
Outcome measures
| Measure |
Delgocitinib Cream 1 mg/g
n=49 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
n=48 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
n=48 Participants
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of 0 (Clear) or 1 (Almost Clear) With ≥2-step Improvement (vIGA-AD TS) From Baseline to Week 8.
|
9 Participants
|
14 Participants
|
15 Participants
|
24 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 8Population: FAS (defined as all randomized subjects exposed to investigational medicinal product).
EASI75 is defined as at least 75% reduction in EASI from baseline.
Outcome measures
| Measure |
Delgocitinib Cream 1 mg/g
n=49 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
n=48 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
n=48 Participants
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
EASI75 at Week 8
|
20 Participants
|
21 Participants
|
28 Participants
|
33 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 8Population: FAS (defined as all randomized subjects exposed to investigational medicinal product)
The time to vIGA-AD TS response is defined as the time from baseline to first assessment of a vIGA-AD score of 0 (Clear) or 1 (Almost Clear) with ≥2-step improvement
Outcome measures
| Measure |
Delgocitinib Cream 1 mg/g
n=49 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
n=50 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
n=51 Participants
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
n=50 Participants
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Time to vIGA-AD TS
|
64 Days
Interval 42.0 to 64.0
|
NA Days
Interval 42.0 to
The median time to achieve success in vIGA-AD was not estimable as fewer participants (less than 50%) reached success in vIGA-AD.
|
64 Days
Interval 28.0 to 64.0
|
44 Days
Interval 26.0 to
The 75% quartile to achieve success in vIGA-AD was not estimable as fewer participants (less than 75%) reached success in vIGA-AD.
|
NA Days
Interval 56.0 to
The median time to achieve success in vIGA-AD was not estimable as fewer participants (less than 50%) reached success in vIGA-AD.
|
Adverse Events
Delgocitinib Cream 1 mg/g
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Delgocitinib Cream 3 mg/g
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Delgocitinib Cream 8 mg/g
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Delgocitinib Cream 20 mg/g
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Delgocitinib Cream Vehicle
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Delgocitinib Cream 1 mg/g
n=49 participants at risk
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
n=50 participants at risk
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
n=50 participants at risk
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
n=51 participants at risk
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
n=50 participants at risk
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/49 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/51 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/50 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/49 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/50 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/51 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
1/49 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/51 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
Other adverse events
| Measure |
Delgocitinib Cream 1 mg/g
n=49 participants at risk
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 3 mg/g
n=50 participants at risk
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 8 mg/g
n=50 participants at risk
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream 20 mg/g
n=51 participants at risk
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream: Cream for topical application
|
Delgocitinib Cream Vehicle
n=50 participants at risk
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
5/49 • Number of events 6 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
6.0%
3/50 • Number of events 4 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
12.0%
6/50 • Number of events 6 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
11.8%
6/51 • Number of events 8 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
8.0%
4/50 • Number of events 5 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
10.2%
5/49 • Number of events 5 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
4.0%
2/50 • Number of events 2 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/50 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
3.9%
2/51 • Number of events 2 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
6.0%
3/50 • Number of events 4 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/49 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
8.0%
4/50 • Number of events 4 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/51 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/50 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • Number of events 2 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/50 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/50 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
5.9%
3/51 • Number of events 3 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/50 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
|
General disorders
Application site pruritus
|
0.00%
0/49 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/50 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
2.0%
1/50 • Number of events 1 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
0.00%
0/51 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
6.0%
3/50 • Number of events 3 • 10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO Pharma A/S seeks publication of all clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. After such a publication is made public, or if no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER