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

Galderma

Status and phase

Completed

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: Adapalene 0.3% / BPO 2.5% gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02932267

RD.03.SPR.110232

Details and patient eligibility

About

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).

Enrollment

50 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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).