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The Results Speak for Themselves

Epiduo® Forte (adapalene and benzoyl peroxide) Gel 0.3%/ 2.5% significantly reduced inflammatory lesion count.1

Pivotal Study Treatment Results

African-American female with IGA 3 at baseline (32 inflammatory lesions, 44 noninflammatory lesions, and 0 nodules). African-American female with IGA 3 at Week 1 (29 inflammatory lesions, 44 noninflammatory lesions, and 0 nodules).

Baseline: IGA 3
Lesion Counts: Inflammatory=32
Noninflammatory=44, Nodule=0

Week 1: IGA 3
Lesion Counts: Inflammatory=29
Noninflammatory=44, Nodule=0

Pivotal Study Design

A multicenter, randomized, double-blind, parallel-group, active- and vehicle-controlled, 12-week study comparing the efficacy and safety of once-daily adapalene 0.3%/BPO 2.5% fixed-dose combination gel (n=217) relative to vehicle (n=69) in subjects with moderate to severe acne vulgaris. At baseline, subjects had between 20 and 100 inflammatory lesions and 30 to 150 noninflammatory lesions. A once-daily adapalene 0.1%/BPO 2.5% arm was included as a safety comparator (n=217); the study was not powered to compare efficacy with adapalene 0.3%/BPO 2.5%.1

Important Safety Information

Indication: Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris. Adverse Events: In the pivotal study, the most commonly reported adverse reactions (≥1%) in patients treated with Epiduo® Forte Gel were skin irritation, eczema, atopic dermatitis and skin burning sensation. Warnings/Precautions: Patients using Epiduo® Forte Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo® Forte Gel and may necessitate discontinuation. When applying Epiduo® Forte Gel, care should be taken to avoid the eyes, lips and mucous membranes.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1‐800‐FDA‐1088.

  1. Epiduo® Forte Gel Clinical Study Report (SRE 18240). Data on file. Galderma Laboratories, L.P.
  2. Tan J, Bourdes V, Bissonnette R, et al. Prospective study of pathogenesis of atrophic acne scars and role of macular erythema. J Drugs Dermatol. 2017;16(6):567-573.
  3. Del Rosso JQ, Stein Gold L, Marchese Johnson S, et al. Efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% gel plus oral doxycycline in subjects with severe inflammatory acne who are candidates for oral isotretinoin. J Drugs Dermatol. 2018;17(3):264-273.
  4. Epiduo® Forte Gel Clinical Study Report (SPR 105061 ). Data on file. Galderma Laboratories, L.P.
  5. DuBois J, Ong GCW, Petkar G, et al. Patient-reported outcomes in acne patients with skin of color using adapalene 0.3%-benzoyl peroxide 2.5%: a prospective real-world study. J Drugs Dermatol. 2019;18(6):514-520.
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Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%

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