BenzaClin Topical Gel (Clindamycin/Benzoyl Peroxyde) Available In US For Acne

Dermik Laboratories, Inc. has announced the availability of BenzaClin? Topical Gel (clindamycin 1% -- benzoyl peroxide 5% gel), a new combination prescription therapy in an aqueous base for the treatment of acne in the United States.

Approved for marketing by the U.S. Food and Drug Administration (FDA), BenzaClin combines clindamycin, the most widely prescribed topical antibiotic for acne, with the antimicrobial benzoyl peroxide, the most frequently used topical preparation for the treatment of acne, in one easy-to-use gel. Clindamycin acts to destroy acne-causing bacteria on the skin while benzoyl peroxide dries the skin and helps prevent the growth of bacteria.

In clinical studies, BenzaClin was shown to be significantly more effective than either benzoyl peroxide or clindamycin alone in reducing the number of inflammatory acne lesions and the total number of lesions on patients with acne. In an open-label, single center study, BenzaClin reduced the number of acne-causing bacteria, known as Propionibacterium acnes, on the face by 99.7 percent in just one week.

"I have studied every topical and systemic antibiotic used in the treatment of acne, and until now, the topical antibiotic with the greatest effect on reducing the inflammation caused by P. acnes was Benzamycin?," said James J. Leyden, MD, professor of dermatology, University of Pennsylvania. "BenzaClin is a new generation, a step forward in acne treatment. In my experience, I believe it is more effective, works more rapidly against P. acnes, plus it has Benzamycin's benefit of containing benzoyl peroxide, which is a component of fighting bacterial resistance."

BenzaClin, a water-based gel, should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry. Clinical trials using BenzaClin in this manner found it to be safe and effective in treating acne.

In one controlled, double-blind, multicenter study, 480 patients with moderate to moderately severe acne were treated twice daily with either BenzaClin, benzoyl peroxide, clindamycin or a placebo. After 10 weeks, researchers found that BenzaClin was significantly more effective than clindamycin or benzoyl peroxide in reducing the number of acne lesions.

In an open-label, single center study designed to compare BenzaClin to clindamycin in the reduction of P. acnes bacteria on the face, 80 subjects were randomized to twice-daily treatment for two weeks with either BenzaClin or three topical forms of clindamycin -- gel, lotion or solution. At the end of one week, BenzaClin produced a significant reduction in facial P. acnes count of 99.7 percent, compared to only 30, 56 and 62 percent for the clindamycin gel, lotion and solution, respectively.

BenzaClin was well-tolerated; the most frequently reported side effect was dry skin, which was experienced by 12 percent of patients in the clinical trials. Diarrhea, bloody diarrhea and pseudomembranous colitis have been reported with topical clindamycin. Discontinuation is recommended if significant diarrhea develops.

BenzaClin is available by prescription now in pharmacies throughout the U.S.

Acne is the most commonly diagnosed skin disorder in the U.S., and is most prevalent in the teenage population. According to the American Academy of Dermatology, close to 100 percent of people between the ages of 12 and 17 have an occasional pimple, regardless of race or ethnic background. By their mid-teens, however, more than 40 percent of adolescents have acne severe enough to require medical treatment by a physician.

Acne occurs when hair follicles become clogged by skin cells that block the opening of pores. If the blocked pore is not visible, it forms a whitehead; if the pore is open and visible, it forms a blackhead. Red, inflamed papules and pustules are formed when acne bacteria break through the whitehead or blackhead. The most common form of acne, acne vulgaris, is a constellation of whiteheads, blackheads, papules and pustules.

Severe acne can cause scarring and affect a person's self-image, causing insecurity and feelings of inferiority. An on-line survey of more than 1,100 teenagers, conducted in 2000 by Yankelovich Partners for the American Counseling Association, found that more than three-quarters of teenage acne sufferers (77 percent) say their condition makes them feel self-conscious, ugly, embarrassed, unhappy or depressed.