Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT05332366
Eligibility Criteria:
Inclusion criteria
For Group 1 only (subjects with FFA):
1. Male or female subject aged 18 years of age or older at the time of consent.
2. Subject has clinically confirmed diagnosis of FFA.
3. 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):
1. Female subject aged 45 years of age or older at the time of consent.
2. Female is postmenopausal.
3. Subject is in good general health.
Exclusion criteria
For all subjects:
1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
2. Presence of hepatitis B or C infection or HIV infection at screening.
For Group 1 only (subjects with FFA):
1. History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia.
2. Subject who has undergone scalp reduction surgery or hair transplantation.
3. Subject is known to have immune deficiency or is immunocompromised.
4. Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization.
5. Subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization.
6. Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to randomization.
7. Subject has received any phototherapy within 4 weeks prior to randomization.
For Group 2 only (healthy subjects):
1. 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.
2. Subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05332366
Study Brief:
Protocol Section:
NCT05332366