Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

Inclusion Criteria:

• Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinicaldiagnosis of acne vulgaris.
• Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) atBaseline.
• Must be willing and able to refrain from use of all other topical products in thetreatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.
• Women must be surgically sterile, or use an effective method of birth control with anegative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
• In good general health and free of any other clinically significant disease state orphysical condition.
• Subject has provided written informed consent / assent.

Exclusion Criteria:

• Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeedduring the study.
• Subject has more than 2 facial nodular lesions; any nodules present will be documentedbut not included in the inflammatory lesion count for analysis.
• Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facialtattoos, or other facial attributes that would interfere with diagnosis or assessmentof acne vulgaris in the opinion of the investigator.
• Subject is planning surgery during the study.
• Subject has a history of hypersensitivity or allergy to clindamycin or lincomycinand/or any of the ingredients in the test articles. Other Eligibility Criteria not listed above will be reviewed for each prospective subjectby the study staff.