Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris

Exclusion Criteria

• •Patient has more than 2 facial nodular lesions, any nodules present will be documented but will not be included in the inflammatory lesion count.
• •Patient has active cystic acne.
• •Patient has acne conglobate.
• •Patient with significant facial hair such as beards or tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
• •Patients with facial sunburn.
• •Any dermatological condition other than acne vulgaris that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne (e.g. rosacea, psoriasis, dermatitis).
• •Females who are pregnant, lactating, or likely to become pregnant during the study.
• •History of allergy or sensitivity to adapalene or other retinoids, or history of any drug hypersensitivity or intolerance which, in the Investigator's opinion, would compromise the safety of the patient or the study.
• •Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that, in the Investigator's opinion, would place the study participant at undue risk by participation.
• •Use of any topical antibiotics, topical steroids, or topical anti-inflammatory products used on the face, any oral antibiotics known to treat acne, any systemic steroids, or any systemic anti-inflammatory agents (other than the use of non-steroidal anti-inflammatory agents) within 28 days of the first dosing day.
• •Use of oral isotretinoin (Accutane®) within 6 months. Use of topical tretinoin (Retin-A®), adapalene (Differin®), tazarotene (Tazorac®), or azelaic acid (Azelex®) within 28 days of the first dosing day.
• •Receipt of any drug as part of a research study within 30 days prior to dosing.
• •Female patients who are using hormonal contraceptives must have been on the same type and strength of hormonal contraceptive for at least 3 months prior to enrollment in the study and throughout the duration of the study.
• •Patients should not use any medicated facial products (soaps, lotions, moisturizers, etc.) or other medicated facial cleansing agents for 14 days prior to study enrollment.
• •Previous participation in this study.