United States Food and Drug Administration (FDA) approved the Aczone (dapsone) Gel, 5 percent for the topical treatment of acne vulgaris. However, patients who have the enzyme deficiency, G6PD (glucose 6-phosphate dehydrogenase), will need blood monitoring to detect whether they are predisposed to a type of anemia (hemolytic anemia).

Aczone, a trademark of QLT USA Inc. is an aqueous topical gel containing 5 percent dapsone. According to scientific research, combining dapsone in a solvent micro particles (SMP) gel enables dapsone to be applied locally and safely. This product produced per cent reduction in the number of acne lesions and better success rate in the overall evaluation Acne results of two randomized, double-blind, vehicle controlled clinical trials in 3000 patients with acne .

Lubricity / peeling, dryness, and erythema were the most frequent adverse events reported in controlled clinical trials. However, there were no significant differences in rates of adverse events in patients treated with Aczone gel and vehicle control.

1.4 percent of the approximately 3500 patients had the enzyme deficiency in the clinical trial Aczone program that is compatible with the frequency in the general population of North America.

The company QLT will undertake a post-approval of Phase IV, 50 patients with acne, G6PD deficiency and follow them for 6 months, after which QLT expects to submit an application to the FDA to reassess the Aczone label.

The president and CEO of QLT Inc., Paul Hastings, said Aczone represents an important clinical advance in dermatology, has demonstrated safety and efficacy in over 4000 patients. We are very pleased with the decision of the FDA and confidence in the potential of Aczone as a new class of treatment for acne patients.