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

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.