Trial Outcomes & Findings for A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia (NCT NCT05332366)
NCT ID: NCT05332366
Last Updated: 2025-03-06
Results Overview
CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2025-03-06
Participant Flow
The trial was conducted in the United States and consisted of 2 cohorts: Cohort 1 included 30 subjects with FFA and Cohort 2 included 5 healthy postmenopausal female subjects. Both cohorts were conducted in parallel.
Eligible subjects were randomized into the trial after a screening period. They were assigned to receive either delgocitinib cream or a placebo twice daily for 12 weeks. After completing this period, they continued using delgocitinib cream for another 12 weeks.
Participant milestones
| Measure |
Delgocitinib - Delgocitinib
Participants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
|
Placebo - Delgocitinib
Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
No Treatment
Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
5
|
|
Overall Study
COMPLETED
|
15
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
Baseline characteristics by cohort
| Measure |
Delgocitinib - Delgocitinib
n=15 Participants
Participants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
|
Placebo - Delgocitinib
n=15 Participants
Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
No Treatment
n=5 Participants
Participants did not receive any treatment. They will only provide a molecular signature of healthy skin to act as a control.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 6.82 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 12.64 • n=107 Participants
|
67.4 years
STANDARD_DEVIATION 9.81 • n=206 Participants
|
64.8 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
33 Participants
n=7 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
5 participants
n=206 Participants
|
35 participants
n=7 Participants
|
|
Height (cm)
|
163.34 units on a scale
STANDARD_DEVIATION 7.557 • n=99 Participants
|
162.49 units on a scale
STANDARD_DEVIATION 6.970 • n=107 Participants
|
165.20 units on a scale
STANDARD_DEVIATION 8.415 • n=206 Participants
|
163.24 units on a scale
STANDARD_DEVIATION 7.257 • n=7 Participants
|
|
Weight (kg)
|
68.41 units on a scale
STANDARD_DEVIATION 15.245 • n=99 Participants
|
75.41 units on a scale
STANDARD_DEVIATION 16.503 • n=107 Participants
|
72.40 units on a scale
STANDARD_DEVIATION 17.418 • n=206 Participants
|
71.98 units on a scale
STANDARD_DEVIATION 15.950 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: No data was collected for "No Treatment" Arm/Groups".
CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.
Outcome measures
| Measure |
Delgocitinib - Delgocitinib
n=15 Participants
Participants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
|
Placebo - Delgocitinib
n=15 Participants
Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
No Treatment
Participants did not receive any treatment. They will only provide a molecular signature of healthy skin to act as a control.
|
|---|---|---|---|
|
Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12.
Chemokine (C-X-C motif) ligand 10 (CXCL10)
|
-2.60 Fold-changes
|
-1.10 Fold-changes
|
—
|
|
Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12.
(C-X-C motif) ligand 9 (CXCL9)
|
-3.10 Fold-changes
|
-1.12 Fold-changes
|
—
|
|
Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12.
Interferon (IFN)-γ
|
-1.49 Fold-changes
|
-1.097 Fold-changes
|
—
|
SECONDARY outcome
Timeframe: Between baseline and Week 12Population: No investigational product was administered in Cohort 2 "No Treatment" Arm/Groups" and thereby were no treatment-emergent AESIs reported in this trial for "No Treatment" Arm/Groups".
Treatment emergent adverse events (TEAEs) were defined as any AEs with onset date on or after the first study treatment dosing.
Outcome measures
| Measure |
Delgocitinib - Delgocitinib
n=15 Participants
Participants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
|
Placebo - Delgocitinib
n=15 Participants
Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
No Treatment
Participants did not receive any treatment. They will only provide a molecular signature of healthy skin to act as a control.
|
|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12.
|
4 events
|
9 events
|
—
|
Adverse Events
Delgocitinib - Delgocitinib
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo - Delgocitinib
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Delgocitinib - Delgocitinib
n=15 participants at risk
Participants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application
|
Placebo - Delgocitinib
n=15 participants at risk
Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
Delgocitinib cream: Cream for topical application Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
No Treatment
Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control.
|
|---|---|---|---|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
46.7%
7/15 • Number of events 7 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Injury, poisoning and procedural complications
Incision site rash
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Investigations
Antinuclear antibody positive
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/15 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
6.7%
1/15 • Number of events 1 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
—
0/0 • Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER