Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris

Exclusion Criteria

• •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• •Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and its excipients.
• •Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
• •Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• •Subjects who have performed wax depilation of the face within 14 days prior to baseline.
• •Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
• •Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
• •Subjects who have used any of the following procedures on the face within 1 month prior to baseline or during the study :
• •1. cryodestruction or chemodestruction,
• •2. dermabrasion,
• •3. photodynamic therapy,
• •4. acne surgery,
• •5. intralesional steroids, or
• •6. X-ray therapy.
• •Subjects who have used any of the following treatments within 1 month prior to baseline or during the study:
• •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.
• •Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study:
• •1. topical steroids,
• •2. topical retinoids,
• •3. α-hydroxy/glycolic acid,
• •4. benzoyl peroxide, or any other topical acne treatments including over-the-counter preparations
• •5. topical anti-inflammatory agents, or
• •6. topical antibiotics.
• •Use of spironolactone within 1 month before Screening/Baseline.
• •Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline.
• •Subjects who have unstable medical disorders that are clinically significant or life-threatening diseases.
• •Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, Subjects who have any malignancy of the skin of the facial area will be excluded.
• •Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
• •Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to cannabinoids, cocaine and barbiturates).
• •Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an Investigational Drug) within 30 days prior to baseline will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
• •Subjects who have been previously enrolled in this study.
• •Subjects who had laser therapy, electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 1 month prior to study entry.
• •Subjects who had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the Investigational Product within 14 days prior to study entry. Cosmetic procedures and facials are prohibited throughout the study
• •Subjects who currently have or have recently had bacterial folliculitis on the face.
• •Subjects with a baseline irritation score of 3 (severe, marked/intense) for erythema, dryness, burning/stinging, erosion, edema, pain and itching will not be enrolled.