Epiduo Forte

EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.

• For topical use only. EPIDUO FORTE is not for oral, ophthalmic, or intravaginal use. 
• Apply a thin layer of EPIDUO FORTE to affected areas of the face and/or trunk once daily after washing. 
• Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). 
• Wash hands after application as EPIDUO FORTE may bleach hair or colored fabrics. 
• Avoid the eyes, lips and mucous membranes.

Each gram of EPIDUO FORTE topical gel contains 3 mg (0.3%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque gel. EPIDUO FORTE is available in pumps containing 15 g, 30 g, 45 g, 60 g or 70 g.

EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%.




Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:

Adapalene:

Molecular formula: C
₂₈H
₂₈O
₃Molecular weight: 412.5

Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula:

Benzoyl Peroxide:

Molecular formula: C
₁₄H
₁₀O
₄Molecular weight: 242.23

EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.

The safety and efficacy of EPIDUO FORTE applied once daily for 12 weeks for the treatment of acne vulgaris were assessed in a multicenter, randomized, double-blind, vehicle-controlled trial, comparing EPIDUO FORTE to vehicle gel in subjects with acne vulgaris. The trial also evaluated adapalene and benzoyl peroxide gel, 0.1%/2.5%, a lower strength product than EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5%. In this trial, 217 subjects were treated with EPIDUO FORTE, 217 subjects with adapalene and benzoyl peroxide, gel, 0.1%/2.5% and 69 subjects with the vehicle gel.

Treatment response was defined as the percent of subjects who were rated “clear” or “almost clear’ at Week 12 with at least a two-grade improvement based on the Investigator’s Global Assessment (IGA), and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts. An IGA score of ‘Clear’ corresponded to clear skin with no inflammatory or non-inflammatory lesions. An IGA score of “almost clear” corresponded to a few scattered comedones and a few small papules.

At baseline, 50% of subjects were graded as “moderate” (IGA Grade 3) and 50% were graded as “severe” (IGA Grade 4) on the IGA scale. Subjects had an average of 98 (range 51-226) total lesions of which the mean number of inflammatory lesions was 38 (range: 20-99) and the mean number of non-inflammatory lesions was 60 (range 30- 149). Subjects ranged in age from 12 to 57 years, with 273 (54%) of subjects 12 to 17 years of age. Approximately equal number of males (48%) and females (52%) were enrolled.

The IGA success rate, mean reduction, and percent reduction in acne lesion counts from baseline after 12 weeks of treatment are presented in the following table.

* This trial was not designed or powered to compare the efficacy of EPIDUO FORTE to the lower strength adapalene and benzoyl peroxide gel, 0.1%/2.5%, nor to compare the lower strength adapalene and benzoyl peroxide gel, 0.1%/2.5% to the vehicle control.

In subjects graded as “severe” (IGA Grade 4), efficacy was observed in the EPIDUO FORTE group.