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Treatment Results

Most subjects were satisfied or very satisfied with treatment at Week 16.

EDEN Study Treatment Results

African-American female before acne treatment with Epiduo Forte gel (baseline). African-American female after acne treatment with Epiduo Forte gel for 16 Weeks.


Week 16

EDEN Study Design

EDEN was an open-label interventional study (N=50) conducted in 3 countries (Mauritius, Singapore, and USA) in subjects of Asian (n=20), Latin-American (n=17), or black/African-American (n=13) ethnicity, with an Investigator’s Global Assessment (IGA) of moderate or severe facial acne (enrollment 2:1), and Fitzpatrick skin type (FST) IV to VI. 74% and 22% of patients had FST IV and V, respectively, whereas 70% and 30% of patients had moderate (IGA 3) and severe (IGA 4) acne, respectively. For 16 weeks, subjects applied 0.3% Adapalene/BPO (once daily) and utilized a skin care regimen (oil control foam wash and oil control moisturizer SPF30). Primary efficacy endpoint: Patient-reported outcomes (PROs) at Week 12 and 16/early termination as measured by Dermatology Life Quality Index (DLQI)/ Children’s DLQI* and patient satisfaction over time and by ethnic population. Other assessments included IGA, Investigator’s Global Assessment of Improvement (GAI), and safety.5

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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