Efficacy

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

Demonstrated nearly 2X the efficacy of vehicle in reduction of inflammatory lesions—ITT population1

Chart showing a -68.7% mean reduction in inflammatory lesion count with Epiduo Forte gel vs. the vehicle gel at -39.2%.
  • 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 sensation1
  • Epiduo Forte Gel demonstrated nearly twice the efficacy of vehicle in reduction of inflammatory lesions1
    • Rapid reduction at Week 1; significant clearing at Week 121

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

Demonstrated nearly 2X the efficacy of vehicle in reduction of inflammatory lesions—ITT population1

Chart showing a -74.4% mean reduction in inflammatory lesion count in IGA 4 subjects with Epiduo Forte gel vs. the vehicle gel at -33.0%.
  • Overall, the most common adverse events in subjects with IGA 4 were nasopharyngitis (7.5%), skin irritation (1.9%), and influenza (1.9%)1
  • Epiduo Forte Gel demonstrated more than 2X the efficacy of vehicle in reduction of inflammatory lesions1
  • Significant clearing at Week 121

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%.2

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 www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

  1. Epiduo® Forte Gel Clinical Study Report (SRE 18240). Data on file. Galderma Laboratories, L.P.
  2. Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and severe inflammatory acne vulgaris effectively treated with single-agent therapy by a new fixed-dose combination adapalene 0.3%/benzoyl peroxide 2.5% gel: a randomized, double-blind, parallel-group, controlled study. Am J Clin Dermatol. 2016; 17:293-303.
  3. 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.
  4. Epiduo® Forte Gel Clinical Study Report (SRE 105061). Data on file. Galderma Laboratories, L.P.
  5. Dreno B, Bissonnette R, Gagne-Henley A, et al. Prevention and reduction of atrophic acne scars with adapalene 0.3%/benzoyl peroxide 2.5% gel in subjects with moderate or severe facial acne: results of a 6-month randomized, vehicle-controlled trial using intra-individual comparison. Am J Clin Dermatol. 2018;19(2):275-286.
  6. Del Rosso JO, 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.
  7. 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.
  8. Alexis AF, Cook-Bolden FE, York JP. Adapalene/benzoyl peroxide gel in 0.3%/2.5%: a safe and effective acne therapy in all skin prototypes. J Drugs Dermatol. 2017;16(6):57 4-581.
  9. According to data from Symphony Health Solutions, Pharmaceutical Audit Suite, Retail Audit, July 2019.
  10. Acne 2018 Speaker Deck. Data on file. Galderma Laboratories, L.P.
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Program Details For All Savings Offers

Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%

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