Combination treatment may work in severe acne cases

Adding adapalene and benzoyl peroxide (Epiduo Gel) 0.1%/2.5% to doxycycline, 100 mg, may be an effective treatment for severe acne, according to results from a study sponsored by Galderma Laboratories. The combination is a retinoid and antimicrobial topical drug used to treat patients with acne vulgaris aged 12 and older.

“While established acne guidelines are used by many dermatologists, there have been limited studies conducted that support the recommended regimens,” says Linda Stein Gold, MD, director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit, and lead investigator, ACCESS Study. “The recent ACCESS [Acne Combination Evaluation Study in Severe Patients], involving 459 patients, is the first controlled trial to formally evaluate the safety and efficacy of a treatment regimen involving adapalene and benzoyl peroxide, with oral antibiotics such as doxycycline, in patients who present more severe acne. As the lead investigator for this important study, I was able to see firsthand the success experienced by the patients taking the combination drug and doxycycline. The combination was well tolerated and effective in treating their more severe acne symptoms. In fact, patients in this study arm demonstrated significant efficacy as early as week 2 compared with the vehicle/doxycycline arm.”

The ACCESS study, was a controlled, multicenter, double-blind trial that assessed the effectiveness and safety of the combination therapy in managing severe acne, which was defined as having at least 20 inflammatory lesions, 30 to 120 non-inflammatory lesions, and 3 or less nodulocystic lesions. Study findings are published in the February 2010 issue of Cutis. The combination treatment led to a median reduction in inflammatory lesions of 72% at week 12.

In the study, the participants were randomly assigned to take doxycycline and either adapalene and benzoyl peroxide or gel vehicle once a day for 12 weeks. Within 2 weeks, those in the adapalene and benzoyl peroxide/doxycycline arm saw marked efficacy, compared with the controls; total median lesion count reductions were 21% and 13%, respectively (P.001). Additionally, by week 12, the treatment was more effective in lowering total inflammatory and non-inflammatory lesion counts.

The most reported side effect was stinging and mild burning. Incidence of related adverse events was 11.8%; events reported were mostly gastrointestinal, which can be common for those taking doxycycline. Other side effects included dryness, irritation, and eyelid irritation.