FDA Approves Prescription Acne Treatment

The FDA has approved Aczone (dapsone) Gel, 7.5%, a new prescription topical treatment for acne patients 12 years and older. Aczone is made by Allergan plc.

A once-a-day application of Aczone Gel, 7.5% has been shown to effectively treat both inflammatory and non-inflammatory acne, with a new concentration of dapsone.

The safety and efficacy of Aczone Gel 7.5% was assessed in two similarly designed 12-week studies with a total of 4,340 acne patients who were randomized to receive Aczone Gel, 7.5% or placebo.

Results indicated that at week 12, inflammatory lesions were reduced by 15.8 lesions in the treatment group, versus 13.9 lesions reduced in the control group.

Furthermore, there was a 20.7 lesion reduction in non-inflammatory lesions among patients treated with Aczone Gel 7.5%, compared to a reduction of 18.0 lesions in the control group.

According to the researchers, the most commonly reported side effects were dryness and itching of the skin.

“Aczone Gel, 7.5%, is a new once-daily option that was shown to have significant improvement in patients’ acne after 12 weeks of use. This new formulation was well-tolerated, which is especially important to many of my female patients,” remarked Linda Stein Gold, MD, Director of Dermatology at Henry Ford Health System in Michigan and a lead investigator in the studies.