The Study

A randomized, multi-center, vehicle-controlled parallel trial compared clindamycin phosphate foam 1% (EVOCLIN) with Clindagel^® (clindamycin phosphate gel, 1%), vehicle foam and vehicle gel. The study was designed to evaluate EVOCLIN Foam 1% by demonstrating its non-inferiority to clindamycin gel 1% and its superiority to vehicle foam and to obtain relevant safety data.

Foam and gel were self-administered by 1,026 subjects in 18 different centers. Subjects with acne vulgaris were 12 years of age and older, and were required to self-administer foam or gel on the face and other affected areas once daily for 12 weeks. Subjects were blinded to the study medication, and subjects were randomly assigned to treatment groups. The study duration was 12 weeks, with subject visits at Baseline and every 3 weeks thereafter for a total of 5 visits. Investigators and study coordinators, like subjects, were blinded to the study medication treatment (active or vehicle). Investigators were blinded to the form of study medication (foam or gel). However, subjects and nurses/coordinators were unblinded to form of study medication (foam or gel).

Efficacy Evaluation

Efficacy was evaluated at the end of treatment in the intent-to-treat (ITT) population (week 12). The primary efficacy endpoint (for facial acne only) measured the percentage reduction from baseline for three lesion counts (total lesions, inflammatory lesions and non-inflammatory lesions). The proportion of patients who had an Investigator's Static Global Assessment score of 0 (clear) or 1 (almost clear) was also determined. Secondary efficacy endpoints measured the proportion of patients with an absolute reduction from baseline in three lesion counts, and the proportion of patients who had a Subject's Global Assessment score of 0 (clear) or 1 (almost clear).

Safety Evaluation

This was comprised of an assessment of vital signs, clinical laboratory assessments (including CBC and chemistry panel), signs and symptoms of facial acne and reported adverse events.

Results/Discussion

In summary, the efficacy objectives were met with statistical significance. The primary and secondary outcome measures at Week 12 showed that:

The Phase III data demonstrated that EVOCLIN is both effective in the treatment of acne vulgaris, and that it is safe and well-tolerated. EVOCLIN is contraindicated in individuals with a history of:

Adverse Reactions

Selected adverse events occurring in 1% or more of subjects include burning, pruritus and dryness at application site and headache. Adverse events were generally mild or moderate in severity, and intermittent or transient in nature. Of the 1,026 patients in the original study group, 3 withdrew because of adverse events. Of these three patients, two patients in the EVOCLIN group experienced mild to moderate treatment-related AEs (mild contact dermatitis of the eyes; facial dryness, burning, and itching at the application site). One patient in the vehicle foam group experienced a non-treatment-related AE (associated with a pre-existing medical condition).

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