A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, an… (NCT05332366) | Clinical Trial Compass
CompletedPhase 2
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
United States35 participantsStarted 2022-04-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
✕. 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.
✕. 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.
What they're measuring
1
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.