Combination Gel Works Better for Acne

    “The main thing that you have to prove with a combination product is that it is more effective than either of the individual ingredients, and that is what we did with this pivotal study,” said study Linda Stein Gold, M.D., Director of Clinical Research in the Department of Dermatology at Henry Ford Health Systems in Detroit.

    She and her colleagues assessed the efficacy and safety of this new combination gel compared with the individual medications and vehicle in 1,668 subjects age 12 and older (mean age 18 years; 51 percent female) with moderate facial acne. All subjects had facial acne vulgaris rated 3 (moderate) on the Investigator’s Global Assessment (IGA) of acne severity scale (range: 0-4) and 20 to 50 inflammatory lesions (IL). In addition, criteria called for subjects to have 30-100 non-inflammatory lesions (NIL), no cysts and no more than 1 nodule.

    Of the 1,668 subjects, 85.7 percent completed the trial. Researchers evaluated the patients at baseline and then again at weeks 1, 2, 4, 8, and 12. At the end of the 12 weeks, the success rate was significantly greater with the combination gel compared to each medication alone and vehicle. In terms of percent change in inflammatory and non-inflammatory lesion counts and total lesion counts, the combination gel was significantly more effective at 12 weeks than each individual component and vehicle. A significant early treatment effect of the combination gel was observed from week 1 for all lesion counts, she said. Success rates were higher at week 4 and sustained through week 12 for the combination gel.

    “We now have a once-daily well tolerated effective therapy that should improve compliance and, therefore, efficacy for all of our acne patients,” Dr. Stein Gold said.

    “It was very well tolerated. The side effects were transient and mostly mild and moderate with just some location irritation.” She noted that the combination gel is the first time a topical retinoid and benzoyl peroxide have been combined into a single product for treating acne.

    The combination gel has been approved and recently marketed in several countries, and is pending FDA approval.