Antifungal octopirox effective, safe globally

November 1, 2005

National report — Because of an increasing resistance of the P. acnes bacterial strains to existing antibiotics, researchers are working to develop new treatments that can effectively control inflammatory acne.

National report - Because of an increasing resistance of the P. acnes bacterial strains to existing antibiotics, researchers are working to develop new treatments that can effectively control inflammatory acne.

La Roche-Posay Pharmaceuticals of France exhibited the results of a study of Effaclar AI, a topical, anti-inflammatory acne agent. Researchers laid out the need for the new medication saying that around the world, in the majority of countries, about 65 percent of P. acnes bacterial strains are resistant to erythromycin and about 25 percent to cyclines. The question becomes the future efficacy of antibiotics in acne patients and the phototoxicity of current acne medications during the summer.

The company's goal was to develop a topical treatment that offered anti-inflammatory action without causing increased resistance to bacteria or the side effect of phototoxicity so that the product was more acceptable for summer use.

The result of their work is Effaclar AI - which stands for anti-inflammatory - a new salicylic acid derivative (LHA) and an anti-fungal agent, octopirox.

In this study, Effaclar AI was compared to a placebo in 80 patients who had simple facial acne with between 10 and 20 inflammatory lesions. They were evaluated at zero, four, eight and 12 weeks. Researchers compared the number of lesions and symptoms as reported by the patients or observed by the investigator.

According to Andre Rougier, M.D., scientific director for La Roche-Posay Pharmaceuticals, "The comedones, the papules and pustules were reduced by about 80 percent, with slightly lesser and slower results being seen in the pustules. The results were almost as good as retinoic acid while offering a significant advantage. Retinoic acid has side effects, but with Effaclar AI, irritation and phototoxicity are avoided."

No significant erythema, desquamation, pruritus, tingling or burning were reported with the test medication compared to study cream, and any signs of those discomforts decreased significantly during the three-month course of the study.

Global use - but not in U.S.

In the United States, octopirox is not approved for use in cosmetics. The product has been on the market in Europe for about two years, and its safety is well-documented, according to Dr. Rougier.

"It is used in all of the European countries, in South America and Asia - and it is safe."

Effaclar K, from the same manufacturer, is available in the United States. Dr. Rougier says it works well on comedonal acne, but because it lacks the antifungal ingredient octopirox, it is not as effective as Effaclar AI on inflammatory acne.