The FDA has approved the expanded indication for Almirall’s Aczone® 7.5% Gel to include patients aged 9-11. Aczone 7.5% Gel was previously approved in February 2016 to treat inflammatory and non-inflammatory acne in patients 12 and older.
The expanded approval was based on data from an open-label safety study to assess safety, pharmacokinetics, and treatment effect of Aczone Gel, 7.5% in 101 patients 9 to 11 years of age with acne vulgaris. Aczone 7.5% Gel was determined to be 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,” explains 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 7.5% Gel is one of thirteen branded products marketed in the US by Almirall, a global family-owned company focused on medical dermatology and skin health. Ron Menezes, President and General Manager at Almirall, LLC, says, “We are very pleased to announce this expanded indication for Aczone 7.5% Gel which further demonstrates Almirall’s commitment to our patients and to continuous innovation in medical dermatology.”