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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02932267
Eligibility Criteria:
Inclusion Criteria:
* Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:
1. Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and
2. A minimum of 25-100 inflammatory lesions (papules and pustules); and
3. A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and
4. No more than two acne nodules (≥ 1 cm),
* Subject with skin phototype IV to VI on Fitzpatrick skin phototype scale,
* Subjects from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American,
Exclusion Criteria:
* Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment,
* Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea
* Female subject who is pregnant, lactating or planning a pregnancy during the trial,
* Subjects having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, dapsone, hydroxyacids, Zinc containing treatments, antiseptics, other anti-inflammatory products or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Wax epilation (2 weeks); Photodynamic therapy (6 weeks); Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne (3 months).
* Subjects having received at least one of the following systemic treatments: Corticosteroids, tetracyclines, other antibiotics (except penicillin) (1 month); Oral retinoids/isotretinoin/ anti-androgens / Cyproterone acetate / Chlormadinone acetate (6 months); Spironolactone/ Drospirenone (3 months); Immunomodulators (3 months) and Oral contraceptives/ oral dapsone for acne(1 month).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02932267
Study Brief:
Protocol Section:
NCT02932267