Proven Tolerability & safety

Erythema

In the safety population,* local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each study visit (N=217)1. The local tolerability profile of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% was comparable to that of Epiduo® Gel 0.1%/2.5%1†

Chart showing mean IGA scores for erythema through Week 12.
  • Mean scores for erythema, dryness, scaling, and stinging/ burning peaked at Week 1, decreased thereafter, and were mild to moderate in severity1
  • Overall, the most common AEs in the Epiduo Forte Gel arm were nasopharyngitis (6.5%), skin irritation (4.1%), gastroenteritis (1.4%), and eczema (1.4%)

*Defined as the intent-to-treat population who applied the study medication at least once.
†This study was not designed or powered to compare the efficacy of Epiduo® Forte (adapalene and benzoyl peroxide) Gel 0.3%/2.5% to the lower strength Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, nor to compare the lower strength Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to the vehicle control.
‡Sub-analysis of Investigator’s Global Assessment (IGA) 4 population from the phase 3 clinical study.

Stinging/Burning

In the safety population,* local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each study visit (N=217)1. The local tolerability profile of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% was comparable to that of Epiduo® Gel 0.1%/2.5%1†

Chart showing mean IGA scores for stinging/burning through Week 12.
  • Mean scores for erythema, dryness, scaling, and stinging/ burning peaked at Week 1, decreased thereafter, and were mild to moderate in severity1
  • Overall, the most common AEs in the Epiduo Forte Gel arm were nasopharyngitis (6.5%), skin irritation (4.1%), gastroenteritis (1.4%), and eczema (1.4%)

*Defined as the intent-to-treat population who applied the study medication at least once.
†This study was not designed or powered to compare the efficacy of Epiduo® Forte (adapalene and benzoyl peroxide) Gel 0.3%/2.5% to the lower strength Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, nor to compare the lower strength Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to the vehicle control.
‡Sub-analysis of Investigator’s Global Assessment (IGA) 4 population from the phase 3 clinical study.

Dryness

In the safety population,* local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each study visit (N=217)1. The local tolerability profile of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% was comparable to that of Epiduo® Gel 0.1%/2.5%1†

Chart showing mean IGA scores for dryness through Week 12.
  • Mean scores for erythema, dryness, scaling, and stinging/ burning peaked at Week 1, decreased thereafter, and were mild to moderate in severity1
  • Overall, the most common AEs in the Epiduo Forte Gel arm were nasopharyngitis (6.5%), skin irritation (4.1%), gastroenteritis (1.4%), and eczema (1.4%)

*Defined as the intent-to-treat population who applied the study medication at least once.
†This study was not designed or powered to compare the efficacy of Epiduo® Forte (adapalene and benzoyl peroxide) Gel 0.3%/2.5% to the lower strength Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, nor to compare the lower strength Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to the vehicle control.
‡Sub-analysis of Investigator’s Global Assessment (IGA) 4 population from the phase 3 clinical study.

Scaling

In the safety population,* local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each study visit (N=217)1. The local tolerability profile of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% was comparable to that of Epiduo® Gel 0.1%/2.5%1†

Chart showing mean IGA scores for scaling through Week 12.
  • Mean scores for erythema, dryness, scaling, and stinging/ burning peaked at Week 1, decreased thereafter, and were mild to moderate in severity1
  • Overall, the most common AEs in the Epiduo Forte Gel arm were nasopharyngitis (6.5%), skin irritation (4.1%), gastroenteritis (1.4%), and eczema (1.4%)

*Defined as the intent-to-treat population who applied the study medication at least once.
†This study was not designed or powered to compare the efficacy of Epiduo® Forte (adapalene and benzoyl peroxide) Gel 0.3%/2.5% to the lower strength Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, nor to compare the lower strength Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to the vehicle control.
‡Sub-analysis of Investigator’s Global Assessment (IGA) 4 population from the phase 3 clinical study.

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.1

Before and after acne picture of patient using Epiduo® Forte Gel. Before and after acne picture of patient using Epiduo® Forte Gel.

See real results from real patients With Epiduo Forte Gel.

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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. Acne 2018 Speaker Deck. Data on file. Galderma Laboratories, L.P.
  3. Epiduo® Forte Gel clinical Study Report (SPR 105061). Data on file. Galderma Laboratories, L.P.
  4. 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.
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Program Details For All Savings Offers

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

The Galderma® CareConnect Program is brought to you by Galderma Laboratories, L.P. The Patient Savings Card provides savings on out‑of‑pocket expenses for up to a 30‑day supply of included Galderma products. If you have valid prescriptions for more than one Galderma product, the copay expense and savings apply to each product. You may use the Patient Savings Card once every 30 days, depending on when you last received a 30‑day supply of each Galderma product. Use of the Patient Savings Card does not obligate you to use or to continue using any Galderma product. You may use the Patient Savings Card at any participating pharmacy located in the United States.

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