Safety and Tolerability of Acanya Gel in Combination With Atralin Gel for Acne Vulgaris

Inclusion Criteria:

• Males and females ≥ 12 years old.

• Subjects must be in good general health as confirmed by medical history and physicalexamination.

• Females of child-bearing potential must have a negative urine pregnancy test at thebaseline visit and agree to be abstinent or use adequate birth control during thestudy (oral contraceptives, Norplant, Depo-Provera, or double barrier methods (e.g.,condom and spermicide).

• Clear diagnosis of facial acne vulgaris for at least 6 months.

• Subject must have a static Physician's Global Assessment (PGA) of 2 (mild severity) or 3 (moderate severity).

• Disease must be stable or slowly worsening for more than one week prior to enteringthe study.

• Subjects or their guardians must be able to read, sign, and date the informed consent,and abide by study restrictions for its duration.

Exclusion Criteria:

• Females who are pregnant, attempting to conceive, or breastfeeding.

• Subjects with known hypersensitivity to any ingredients in the study drugs.

• Subjects with overt signs of skin atrophy, telangiectasias or other skin findings thatwould affect efficacy evaluation.

• Subjects with a current active skin malignancy or infection.

• Subjects requiring the use of medications known to alter the course of acne vulgarisduring the study treatment.

• Subjects who have received systemic antibiotics within 2 weeks.

• Subjects using systemic corticosteroids or immunosuppressants within 28 days ofentering the study.

• Subjects who have received any topical therapies for acne vulgaris within 7 days ofentering the study.

• Subjects taking birth control pills used solely for acne control.

• Subjects who are currently participating in or, within the previous 28 days, haveparticipated in another study for the treatment of acne vulgaris.

• Subjects with clinical conditions that may post a health risk to the subject by beinginvolved in the study or detrimentally affect regular follow-up of the subject.

• Subjects who have Crohn's disease, colitis, or if subjects ever developed colitis orsevere diarrhea with past antibiotic use.