New Acne Gel Gets FDA Approval
The FDA has approved a new gel to treat acne.
Aczone Gel 5%, made by QLT Inc., is approved to treat acne vulgaris. That's a common skin condition in which oil and dead skin cells clog the skin's pores.
More than 85 percent of teens experience acne. Some people — especially women — have acne into their 40s and 50s.
The water-based gel's active ingredient is dapsone. It is the only acne treatment to use dapsone in a topical formulation, states a QLT news release.
Gel's Clinical Trials
Aczone was tested in two clinical trials with more than 3,000 acne patients aged 12 and older. It was compared with a similar gel without dapsone.
Aczone fared better than the comparison gel. After three months, Aczone reduced more pimples.
Women tended to have more success and fewer pimples with Aczone than men.
Acne Myths Persist Despite Lack of Evidence
The most commonly reported side effects in the clinical trials were oiliness/peeling, dryness, and skin redness. Side effects were similar with both gels.
Patients will need to be screened to see if they are predisposed to have a type of potentially severe anemia called hemolytic anemia due to a lack of the G6PD enzyme.
A deficiency of this enzyme may result in the destruction of oxygen-carrying red blood cells when a person is exposed to certain medications or chemicals, has certain viral or bacterial infections, and/or inhales the pollen of, or eats, fava beans.
Those who have the rare enzyme deficiency will need to have regular blood counts done, states the release.
According to QLT, the deficiency was present in 1.4 percent of the trials' patients. It's more common in some groups, reportedly affecting 10 percent to 14 percent of black men, states the release.
QLT has agreed to do a postapproval study in 50 patients with G6PD deficiency. Depending on the results of the study, the company may submit an application to the FDA to re-evaluate the gel's label.
The active ingredient in Aczone is also used to treat leprosy. However, it's taken as a pill for this condition.
By Miranda Hitti, reviewed by Michael W. Smith, MD
SOURCES: News release, QLT Inc. WebMD Medical Reference from Healthwise: "Acne Vulgaris — Topic Overview." Medscape Medical News: "FDA Approvals: BiDil, Megace ES, Aczone." RxList.com, a WebMD company. WebMD Medical Reference from Healthwise: "Glucose-6-Phosphate Dehydrogenase Deficiency."