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  • USFDA approves Epiduo...

USFDA approves Epiduo Forte gel for ACNE

Meghna A SinghaniaWritten by Meghna A Singhania Published On 2015-07-19T13:23:39+05:30  |  Updated On 19 July 2015 7:53 AM GMT
USFDA approves Epiduo Forte gel for ACNE
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Great news for  teenagers suffering from ACNE. Their acne troubles are going to come to an end as early as within a week, with a newly USFDA approved Epiduo Forte gel.The US Food and Drug Administration USFDA, approved a topical gel combination of adapalene 0.3% and benzoyl peroxide 2.5% (Epiduo Forte, Galderma) for the treatment of moderate to severe acne vulgaris in patients aged 9 years...

Great news for  teenagers suffering from ACNE. Their acne troubles are going to come to an end as early as within a week, with a newly USFDA approved Epiduo Forte gel.


The US Food and Drug Administration USFDA, approved a topical gel combination of adapalene 0.3% and benzoyl peroxide 2.5% (Epiduo Forte, Galderma) for the treatment of moderate to severe acne vulgaris in patients aged 9 years and older, the company has announced.


The approval was based on a phase 3 randomized double-blind study involving 217 patients. In the study, Epiduo Forte gel was superior to vehicle control gel in the overall study population of patients with moderate to severe acne at week 12 for the Investigator's Global Assessment Success Rate and for changes in inflammatory and noninflammatory lesion count, the company notes in a news release announcing the approval.


In addition, half of the patients had severe acne at baseline, and more than half of this group (50.5%) saw marked improvement during the study, with results seen as early as 1 week, with continued improvement through week 12, according to the company.


"Acne is a challenging condition to manage. It can vary greatly from patient to patient, can have a significant physical and psychosocial impact on sufferers, and patients can find treatment adherence difficult to maintain," Jonathan Weiss, MD, a board-certified dermatologist at Gwinnett Dermatology, PC, and lead investigator on the study, said in the news release.


"For many patients, rapid results are especially important, and some acne treatments take time to show effect. We were very excited to see in the clinical trial that people using Epiduo Forte gel saw results as early as 1 week, with efficacy continually improving through week 12," Dr Weiss added.


Erythema, scaling, dryness, stinging/burning, and irritant and allergic contact dermatitis may occur with Epiduo Forte, requiring discontinuation in some cases.


Patients using Epiduo Forte gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided, the company said.


Epiduo Forte gel will be available by prescription beginning in September.


The formulation of adapalene 0.1% and benzoyl peroxide 2.5% (Epiduo) was approved by the FDA in 2009 for use in patients 12 and older.

Acne Dermatology Epiduo Forte gel USFDA 
Meghna A Singhania
Meghna A Singhania

    Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country.She is a member of the Association of Healthcare Journalists. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

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