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

Study Overview
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Brief Summary
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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).

Official Title
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Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene 0.3% / BPO 2.5% gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by: Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and A minimum of 25-100 inflammatory lesions (papules and pustules); and A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and 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).

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapalene / BPO gel<br>Adapalene 0.3% / BPO 2.5% gel, once daily in the evening | Drug: Adapalene 0.3% / BPO 2.5% gel<br>* Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks<br>* Other names: Epiduo Forte / Tactupump gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire | % of subjects satisfied to very satisfied with study treatment at week 12 | At week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Dark skin