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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03043534
Eligibility Criteria:
Inclusion Criteria:
1. Males with at least a two year history of the symptoms of PFB.
2. Must be age 20-60 years of age (inclusive).
3. Must wet shave using just a prep and blade razor at least 3 or more times per week, and be willing to continue that regimen during the study.
4. Must have Mild -to moderate PFB based on IGA rating scales. There are no lesion count inclusion requirements.
Exclusion Criteria:
1. Use of systemic (oral antibiotics) within the last 4 weeks.
2. Use of topical prescriptions (topical clindamycin, topical retinoids, topical metronidazole, topical sulfacetamide/sulfur, topical adapalene, benzoyl peroxide, salicylic acid, glycolic acid, retinol,chemical peels) or over-the-counter products the subject has used for PFB or Hair Growth within the last 2 weeks. Use of oral retinoids, laser therapy or electrolysis treatments or waxing in beard area in last 12 months.
3. Individuals who do not wet shave with a bladed razor, or who use electric shavers.
4. Subjects must not have used any type of cleansing or shave brush to the face for six weeks prior to Baseline.
5. Individuals who have removed a beard within last two months.
6. Individuals who have a history of alopecia areata of the face.
7. Confounding dermatological conditions that would, in the opinion of the principal investigator, preclude participation in this study such as:
* Immune deficiency disease (HIV positive, AIDS, sarcoidosis)
* On immunosuppressive drugs (e.g. oral corticosteroids)
* Autoimmune disease (lupus, scleroderma, diabetes mellitus, vitiligo)
* Koebnerizing diseases (e.g. psoriasis, lichens planus, (HPV) human papilloma virus, facial verruca, molluscum contagiosum)
* Tuberculosis, Hepatitis B
* History of Keloids
* History of Herpes simplex in treated area
* Bacterial infection of face including abscesses and draining sinuses of facial area
* Cystic Acne, other acne in bearded area which interferes with shaving as well as the ability to distinguish PFB lesions from acne
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT03043534
Study Brief:
Protocol Section:
NCT03043534