Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
Condition: Acne
Intervention: Adapalene and Benzoyl Peroxide Gel; Adapalene and Benzoyl Peroxide Gel (Reference); Placebo gel
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 903.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to
      an FDA approved product for the treatment acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and non-pregnant female subjects, 12 to 40 years of age (inclusive), with a
             clinical diagnosis of at least moderate facial acne vulgaris

          -  Inflammatory lesion (papules and pustules) count of 20 to 50 (inclusive)

          -  Non-inflammatory (open and closed comedones) lesion count of 25 to 100 (inclusive)

          -  No more than two nodulocystic lesions (i.e., nodules and cysts) on the face including
             those present on the nose, were enrolled.

          -  Subjects must also have had a Baseline IGA score of 3 or 4 on a severity scale of 0 to
             4 to be enrolled.

        Exclusion Criteria:

          -  Subjects who are pregnant, nursing, or planning a pregnancy within the study
             participation period.

          -  Presence of more than 2 facial Nodulocystic lesions (i.e. nodules and cysts)

          -  Subjects with active cystic acne or Polycystic Ovarian Syndrome

          -  Presence of any other facial skin condition that, in the Investigator's opinion, might
             interfere with acne vulgaris diagnosis and/or evaluations (e .g., on the face:
             rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions
             caused by medications, steroid acne, steroid folliculitis, or bacterial folliculiti
             s).

          -  Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
             with diagnosis or assessment of acne vulgaris.

          -  Acne conglobata, acne fulminan s, or secondary acne (chloracne, drug-induced acne,
             etc.)

          -  Use of antipruritics including antihistamine, within 24 hours prior to all study
             visits (Visit l/Baseline through Visit 4).

          -  Use of medicated make-up throughout the study and significant change in the use of
             consumer products within 30 days of study entry and throughout the study (other than
             study supplied cleanser and lotion).

          -  Use within 6 months prior to baseline or during the study of oral retinoids (e.g.
             Accutane"') or therapeutic vitamin A supplements of greater than 10,000 units/day
             (multivitamins are allowed).

          -  Use within 1 month prior to baseline or during the study of therapeutic vitamin D
             supplement (multivitamins are allowed).

          -  Use within 1 month prior to baseline or during the study of 1) systemic sterOids', 2)
             systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral
             retinoids which require a 6-month washout), or 4) systemic anti-inflammatory agents".
             (' Intranasal and inhaled corticosteroids do not require a washout and may be used
             throughout the study if at a stable and standard dose. "Subjects may use Acetaminophen
             for pain relief, as needed, throughout the study)

          -  Use within 14 days prior to baseline or during the study of 1) topical sterOids, 2)
             topical retinoids, 3) topical acne treatments including over-the-counter preparation
             (e.g. azelaic acid,etc.) 4)a-hydroxy/glycolic acid, 5) benzoyl peroxide, 6) topical
             anti-inflammatory agents, or 7) topical antibiotics.