Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne

• Status: Completed
• Trial end date: 2018-01-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face.

All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face.

The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Adapalene; Benzoyl Peroxide

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).