Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene 0.3% / BPO 2.5% gel
Intervention description: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks
Intervention MeSH terms: Adapalene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne; Dark skin

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).
    

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).