Phase 2
N=35
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
Frontal Fibrosing Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT05332366 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: 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. — -3.10; -1.12; -2.60; -1.10 Fold-changes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Delgocitinib cream (Drug); Delgocitinib cream vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-3.10; -1.12; -2.60; -1.10; -1.49; -1.097 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12. |
4; 9 | — |
Summary
This purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing the FFA disease signature in active lesions. The trial also investigated the clinical effect of delgocitinib cream on FFA compared to a placebo cream.
Eligibility Criteria
Inclusion criteria
For Group 1 only (subjects with FFA):
- Male or female subject aged 18 years of age or older at the time of consent.
- Subject has clinically confirmed diagnosis of FFA.
- Subject has a target area with a perifollicular erythema score ≥ 2 and a perifollicular scale score ≥ 2 at Screening and Day 1.
For Group 2 only (healthy subjects):
- Female subject aged 45 years of age or older at the time of consent.
- Female is postmenopausal.
- Subject is in good general health.
Exclusion criteria
For all subjects:
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
- Presence of hepatitis B or C infection or HIV infection at screening.
For Group 1 only (subjects with FFA):
- History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia.
- Subject who has undergone scalp reduction surgery or hair transplantation.
- Subject is known to have immune deficiency or is immunocompromised.
- Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization.
- Subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization.
- Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to randomization.
- Subject has received any phototherapy within 4 weeks prior to randomization.
For Group 2 only (healthy subjects):
- Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
- Subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.
Data sourced from ClinicalTrials.gov (NCT05332366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.