The Food and Drug Administration (FDA) has approved Aczone (dapsone; Almirall) Gel 7.5% for the topical treatment of acne vulgaris in patients aged ≥9 years. Previously, the treatment had been indicated for patients 12 years of age and older.
The approval of Aczone Gel 7.5% in patients 9 to 11 years of age was supported by evidence from adequate and well-controlled clinical trials in 1066 patients 12 years of age and older and with additional pharmacokinetic and safety data in pediatric patients 9 to 11 years of age from an open label study (N=100). Based on these trials, it was determined that the treatment was safe and effective in this patient population.
“While acne may be commonly thought of as an issue for teenagers, according to treatment guidelines, acne is also prevalent in children under the age of 12,” said clinical study investigator and pediatric dermatologist, Adelaide Hebert, MD, of McGovern Medical School at UTHealth Houston. “Research revealed that treatment options like Aczone 7.5% Gel can be used in these younger individuals who are living with the detrimental effects of acne.”
Aczone Gel 7.5% is applied to the affected area once daily. If no improvement is seen after 12 weeks, treatment should be reassessed. The product is supplied in an airless pump in 30g, 60g, and 90g sizes.
For more information visit almirall.us.