Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris

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.