Status:
COMPLETED
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
Lead Sponsor:
LEO Pharma
Conditions:
Frontal Fibrosing Alopecia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 lesio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05332366
Start Date
April 19 2022
End Date
May 22 2023
Last Update
March 6 2025
Active Locations (1)
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1
LEO Investigational Site
Burlington, Massachusetts, United States, 01805