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Acne: FDA Approved Aczone For Acne Treatment |
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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, |
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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 |
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