P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

Absolute Change in Inflammatory Lesion Counts

Change in inflammatory lesion count from Baseline to Week 12

Time frame: Baseline and Week 12

Absolute Change in Non-inflammatory Lesion Counts

Absolute Change in non-inflammatory lesion count from Baseline to Week 12

Time frame: Baseline and Week 12

Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment

Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)

Time frame: Baseline and Week 12