FDA approves Allegran’s acne medication ACZONE

The U.S. Food and Drug Administration (FDA) recently approved Allegran’s prescription topical acne treatment for patients ages 12 and over, ACZONE Gel, 7.5%.

The medication has shown that it is effective in the treatment of both inflammatory and non-inflammatory acne as a once-a-day applicant with a concentration of dapsone.

The clinical trials of ACZONE included 4,340 patients with acne and demonstrated its effectiveness. The once-a-day dose of the medication will be delivered with a pump system. In the trials, the safety and effectiveness of ACZONE was evaluated in two 12-week studies that were randomized, multi-centered, double-blind and vehicle controlled. The 4,340 patients who took part in the two trials were given either ACZONE or vehicle on a completely random basis. The Global Acne Assessment Score showed a success rate of 29.8 percent in patients.

In addition to the positive results of the trials, ACZONE showed a high profile for being tolerable in patients. Out of the 2,161 patients who received ACZONE, only 1.1 percent suffered from mild dryness on the skin where they applied the medicine. Overall, ACZONE has proven that it can help patients see significant improvement over 12 weeks of use.