New help for acne: Large study shows new combination gel effective, safe, fast-acting

March 1, 2009

A single product that combines a retinoid and benzoyl peroxide is showing promise against acne. The new gel is not only safe and effective, but fast-acting, too.

Key Points

"This is the first time that a topical retinoid and benzoyl peroxide have been combined into one product," says Linda Stein Gold, M.D., director of clinical research at Henry Ford Hospital in Detroit.

"We have found that it offers effective, rapid results without the concern of bacterial resistance," Dr. Stein Gold tells Dermatology Times.

And additional trials have studied 0.1 percent benzoyl peroxide 2.5 percent gel for up to 12 months of once-daily use. These long-term safety studies have shown this combination to be safe and well-tolerated for first line, as well as maintenance use.

"Physicians can now offer patients the convenience of once-daily dosing, with the flexibility of morning or evening application," Dr. Stein Gold says.

Dr. Stein Gold and her team studied the combination product in a large clinical trial involving 1,656 patients, comparing it to its individual ingredients (adapalene 0.1 percent and BPO 2.5 percent), as well as to vehicle.

The multicenter, randomized, double-blind study included male and female participants who were 12 years and older (mean age, 18.2 years) with facial acne vulgaris rated 3 (moderate) on the Investigator's Global Assessment (IGA) of acne severity scale, ranging from 0 = clear to 4 = severe. Participants chosen had from 20 to 50 inflammatory lesions, 30 to 100 non-inflammatory lesions, no cyst and no more than one nodule.

During the trial, patients were treated once daily for 12 weeks, with evaluations performed at screening, baseline, and weeks one, two, four, eight and 12.

At the end of the study, the success rate was significantly greater with the adapalene-BPO gel compared to the monads (adapalene gel and BPO gel) and vehicle: 30.1 percent, 19.8 percent, 22.2 percent and 11.3 percent, respectively.

Tolerability was comparable for all treatment groups by week 12. Stinging and burning were slightly higher in the combination group at the beginning of the study, according to Dr. Stein Gold, but the severity was mild and tended to resolve with time.

According to Hilary Baldwin, M.D., president of the American Acne and Rosacea Society, "Epiduo is the first combination product for acne in the United States that contains a retinoid.

"Dermatologists routinely use polytherapy with an antimicrobial agent and topical retinoid recognizing the multifactorial pathogenesis of acne."

However, says Dr. Baldwin, associate professor and vice chairman of the department of dermatology at State University of New York at Brooklyn, "the use of multiple products often beget medication non-adherence, especially in the teenage population.

"In the pivotal trials," she says, "Epiduo demonstrated efficacy in the treatment of both inflammatory and noninflammatory mild-to-moderate acne. Tolerability was very good - mild or less, and similar to placebo."

Conclusion

"Overall, more patients in the adapalene-BPO group experienced local tolerability signs and symptoms compared to the other groups," Dr. Stein Gold says. "However, those were transient and mostly mild or moderate in severity. The safety of adapalene-BPO was found to be not materially different from the monads."

Adapalene-BPO gel was found to be superior to the individual monads and gel vehicle, with a favorable benefit/risk ratio and a rapid onset of improvement.

"This single-product medication provides the prescribing physician with a unique antibiotic-free, fixed-dose combination for the first-line management of acne vulgaris," she adds.

"What Epiduo brings to the table," Dr. Baldwin says, "is an effective product for mild-to-moderate acne, with good tolerability and the convenience of a single-dose application."

Coming soon

Other combination products to treat acne are on the launching pad, according to Dr. Baldwin.

"One of these is Acanya (Arcutis Pharmaceuticals)," she says. "It's clindamycin 1.2 percent and benzoyl peroxide, low dose at 2.5 percent."

"Another is topical dapsone 5 percent gel (Aczone, Allergan), which has also been released recently," she adds.

Disclosures: Dr. Stein Gold is principal investigator and adviser for Galderma. Dr. Baldwin is a member of the Women's Dermatologic Society.