University of Cincinnati (UC) dermatologists are testing a new topical gel designed to reduce abnormal clogging of the pores while simultaneously fighting off certain bacterial infections linked to severe acne development.
Led locally by Pranav Sheth, MD, and Debra Breneman, MD, this multi-center, phase-3 trial will determine whether the dual-acting topical gel is more effective than the single medications physicians currently prescribe for acne prevention.
The investigational drug is a combination of the retinoid adapalene, a vitamin A--like compound that has been shown to reduce the formation of comedone (clogged pores) and inflammation, and the strong antibacterial agent benzoyl peroxide. Both medications are currently approved by the U.S. Food and Drug Administration for the treatment of acne, but they are prescribed as single agents--not a combined therapy.
Although the exact cause of acne is unknown, scientists believe genetics, hormones, oil production and diet all play a role. These factors, as Sheth explains, combine to clog the pores, allow excessive bacteria growth and produce the inflammation that causes acne.
"This new gel was designed to suppress the factors that lead to acne development," says Sheth, assistant professor of dermatology at UC. "Currently, patients are given several separate topical agents with different mechanisms of action to create the desired effect on acne.
"By combining the two medications into one treatment gel," he adds, "we hope to produce a convenient product that the patient is more likely to use but also yields better results than current individual therapies."
Researchers are currently recruiting about 40 individuals aged 12 or older who have been diagnosed with severe acne. Study participants will be randomized into four treatment groups who will receive the experimental combination drug, adapalene topical gel only, benzoyl peroxide gel only or a placebo.
Participants will apply the gel to their faces every evening for 12 weeks, keeping a log of any moisturizers, sunscreens or other topical creams they have applied. Researchers will track acne changes every one to four weeks during follow-up examinations. Once treatment is complete, study participants will complete several brief surveys on quality-of-life issues related to acne and the trial gel's effectiveness in alleviating their acne.
Study participants will be compensated for their time and receive study-related visits, procedures and drugs at no cost. For trial enrollment information, call Vivian Berger at (513) 475-7575.
This trial is sponsored by Galderma USA, maker of the investigational gel. Sheth and Breneman have no financial interests in the company.
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