Title:
Acne: FDA Approved Aczone For Acne Treatment
Word Count:
278
Summary:
The U.S. Food and Drug Administration (FDA) approved to market Aczone
(dapsone) Gel, 5 per cent for acne vulgaris topical treatment. But
patients who have the enzyme deficiency, G6PD (Glucose 6-phosphate
dehydrogenase), will need to be monitored with regular blood counts to
detect if they are predisposed to one type of anemia (hemolytic anemia).
Keywords:
acne solutions products
Article Body:
The U.S. Food and Drug Administration (FDA) approved to market Aczone
(dapsone) Gel, 5 per cent for acne vulgaris topical treatment. But
patients who have the enzyme deficiency, G6PD (Glucose 6-phosphate
dehydrogenase), will need to be monitored with regular blood counts to
detect if they are predisposed to one type of anemia (hemolytic anemia).
Aczone, a trademark of QLT USA Inc., is an aqueous topical gel which
contains 5 per cent dapsone. According to scientific research, combining
dapsone in a Solvent Microparticulate (SMP) gel enables dapsone to be
applied topically and safely. This product achieved significant per cent
reduction in the number of acne lesions and better success rate on the
Global Acne Assessment Score in two randomized double-blind, vehicle
controlled clinical studies in 3000 acne patients.
Oiliness/peeling, dryness, and erythema were the most common adverse
events reported from controlled clinical trials. However, there were no
significant differences in the adverse event rates between Aczone Gel and
vehicle control treated patients.
1.4 per cent of about 3500 patients had the enzyme deficiency -in the
Aczone clinical trial program- which is consistent with the incidence in
the general North American population.
The company QLT will undertake a post-approval Phase IV study in 50 acne
patients who have G6PD deficiency and follow them for 6 months, after
which QLT expects to submit an application to the FDA to re-evaluate the
Aczone label.
The President and Chief Executive Officer of QLT Inc., Paul Hastings,
stated that “Aczone represents an important clinical advance in
dermatology, has demonstrated safety and efficacy in over 4,000 patients.
We are very pleased with the FDA's decision and confident in Aczone's
potential as a new class of treatment for acne patients”.