Source: Kardiologiia  |  Posted 8 years ago

By Bruce Sylvester

WASHINGTON, DC -- February 13, 2004 -- Investigative clindamycin phosphate foam 1% appears to be a safe, effective and well tolerated treatment for acne vulgaris, and showed similar or better clinical efficacy than clindamycin phosphate gel 1%, researchers reported here on February 8th at the American Academy of Dermatology 62nd Annual Meeting.

"Clindamycin foam has demonstrated safety and efficacy in this study," said Alan Shalita, MD, Professor of Dermatology, S.U.N.Y. Downstate Medical Center, Brooklyn, New York. "And the benefits of its use for acne vulgaris appear to outweigh the risks associated with treatment."

For their multicentre, double blind, double dummy, vehicle controlled, 12-week study the investigators enrolled 1,026 subjects with acne vulgaris who were 12 years or older. The subjects had Investigator's Static Control Assessment (ISGA) score of 2 or greater at baseline, with 17 to 40 facial inflammatory lesions (papules and pustules) including nasal lesions, 20 to 50 facial non-inflammatory lesions (open and closed comedomes) excluding nasal lesions. All subjects were in good general health.

Subjects were randomised to 4 treatment groups using a 3:1:3:1 ratio -- clindamycin foam, vehicle foam, clindamycin gel or vehicle gel. Subjects administered their assigned treatment once daily, morning or evening.

Each subject was evaluated at baseline and at weeks 3, 6, 9 and 12. At each evaluation, investigators performed acne lesion counts (total, inflammatory and non-inflammatory), ISGA scoring of facial acne vulgaris and a Subject's Global Assessment. They also evaluated the signs (scaling, dryness, erythema, oiliness) and symptoms (burning and itching) of acne vulgaris. They used vital signs, lab assessments and reported adverse events to evaluate safety.

"In both the intent-to-treat and per-protocol analyses clindamycin foam was demonstrated to be statistically non-inferior to clindamycin gel for the proportion of subjects with treatment success and for the percent reduction in all lesion counts [total, inflammatory and non-inflammatory]," the investigators reported. "Clindamycin foam was demonstrated to be statistically superior to vehicle foam for the intent-to-treat and per-protocol analyses for both primary end points."

The most commonly reported adverse event among the intent-to-treat subjects was application-site burning, reported by 6% of foam subjects, 1% of gel subjects, 7% of vehicle foam subjects and 2% of vehicle gel subjects. The events were mild to moderate, intermittent and well tolerated. Pruritus and dryness appeared in fewer than 2% of clindamycin foam subjects, and the agent was, "very well tolerated," the authors noted.

Clindamycin phosphate has been a standard topical therapy for mild-to-moderate acne for more than 20 years. The investigative foam formulation has the advantages of ease-of- application, no fragrance, no staining, quick breaking, low-residue and is useful for large body areas.

[Study title: Clindamycin Phosphate Foam, 1%, Versus Clindamycin Phosphate Gel, 1%, For the Treatment of Acne Vulgaris: Results of a Phase III Study. Poster presentation 95]