FDA Approves Prescription Acne Treatment
Once daily application of Aczone Gel effectively treats both inflammatory and non-inflammatory acne.
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,”
Newsletter
Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.
Related Articles
Effectively Managing Immunizations in the Long-Term Care SettingSeptember 18th 2025
Creating a Culture of Quality in Fast-Melt Tablet DevelopmentSeptember 18th 2025
Advise Patients About Self-Care Measures to Treat Mild to Moderate GI IssuesSeptember 18th 2025
