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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2023
  • participants needed
    35
  • sponsor
    LEO Pharma
Updated on 5 May 2022
Accepts healthy volunteers

Summary

This purpose of this trial is 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 will also investigate the clinical effect of delgocitinib cream on FFA compared to a placebo cream.

Details
Condition Frontal Fibrosing Alopecia
Treatment Delgocitinib cream, Delgocitinib cream vehicle
Clinical Study IdentifierNCT05332366
SponsorLEO Pharma
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

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
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