Efficacy

Reducing Inflammatory Lesions Can Decrease the Risk of Scarring3

The OSCAR study examined the role early treatment of acne with Epiduo® Forte Gel played in helping to prevent acne scar formation.4

Image showing the results of a 24-Week, split-face study of Epiduo Forte Gel vs. vehicle gel.

Effect of adapalene 0.3%/benzoyl peroxide 2.5% in Epiduo Forte Gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne subjects4

IGA=Investigator’s Global Assessment; SGA=Investigator’s Scar Global Assessment.
ITT = Intent to treat.
*Total acne scar counts; Mean ±SD.
†IGA: 3=moderate; 4=severe.
‡SGA: 2=mild (scars are easily recognizable; less than half of the affected face area involved); 3=moderate (more than half and less than 75% of the affected face area is involved).

In the OSCAR Study, Epiduo Forte Gel Effectively Treated Inflammatory Acne Lesions Through Week 244

Epiduo Forte Gel significantly reduced inflammatory lesion count over 24 weeks4

Chart showing a -86.7% reduction in inflammatory lesion count from baseline with Epiduo Forte gel vs. -59.7% with vehicle gel.

Early onset of action was observed with a statistically significant difference as early as Week 1 and at every study visit through Week 244

ITT=Intent-to-treat
LOCF=Last observation carried forward.

In the OSCAR Study, Epiduo Forte Gel Effectively Treated Inflammatory Acne Lesions Through Week 244

The percentage of subjects rated clear or almost clear with Epiduo Forte Gel significantly improved compared to vehicle at all study visits4

Chart showing that 64.2% of patients treated with Epiduo Forte gel achieved clear/almost clear vs. 19.4% treated with vehicle gel.

More than 3 times as many subjects were clear or almost clear at Week 244

Clear (IGA score of 0)=clear skin with no inflammatory or noninflammatory lesions; almost clear (IGA score of 1)=a few scattered comedones and a few small papules.
IGA=Investigator’s Global Assessment.
ITT=Intent-to-treat.
LOCF=last observation carried forward.2,9

Epiduo Forte Gel Reduced Scar Risk with a 30% Difference at Week 24 vs Vehicle6

Patients experienced a 15.5% reduction in acne scars from baseline with Epiduo Forte Gel vs an increase of 14.4% with the vehicle8†

Chart showing that statistically significant scar reduction was seen as early as Week 1 and was sustained over 24 Weeks with Epiduo Forte gel vs. vehicle.

Failure to Treat Acne with Epiduo Forte Gel Increased the Risk of Scarring

OSCAR study demonstrated high subject satisfaction with Epiduo Forte Gel vs vehicle

  • After 24 weeks of treatment, 90% of subjects reported they were satisfied to very satisfied with Epiduo Forte Gel vs 59% with vehicle5

Well-tolerated by study subjects

  • The most common treatment-related adverse events (AEs) were mild to moderate skin irritation (reported by 15% of subjects treated with Epiduo Forte Gel and 6% of subjects treated with vehicle)5
  • No serious or severe AEs reported5
  • Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo Forte Gel and may necessitate discontinuation

Oscar Study Design

A two-phase, randomized, multicenter, investigator-blinded, vehicle-controlled trial evaluating once-daily Epiduo® Forte Gel in moderate to severe acne subjects 16 to 35 years old with a clinical diagnosis of moderate to severe acne vulgaris on the face (defined by IGA score of 3 or 4, with the same score on both sides); a minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); no more than 2 acne nodules (≥1 cm); and ≥10 atrophic acne scars in total (>2 mm), excluding the nose. Phase 1 was a split-face, 24-week, investigator-blinded, vehicle-controlled study (n=67) at 8 visits (baseline, Weeks 1, 4, 8, 12, 16, 20, and 24). Phase 2 was a whole-face, open-label study in which select subjects (investigator and subject agreement to continue) continued treatment for an additional 24 weeks with 2 visits (weeks 36 and 48). Primary endpoint was scar count.4

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.
Galderma logo

© 2023 Galderma Laboratories, L.P. United States, All Rights Reserved. All trademarks are the property of their respective owners.

This site intended for U.S. audiences only. Information in this website is not intended as medical advice. Talk to your doctor about medical concerns. California - Do Not Sell My Personal Information

USMP/EFO/0262/1019

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.

The Galderma CareConnect Program Patient Savings Card may not be combined with any savings, discount, free trial, or other similar offer for the same prescription. The Patient Savings Card is not transferable and is void if reproduced. The Patient Savings Card is not health insurance. Limit one (1) Patient Savings Card per patient. The Galderma CareConnect Program Patient Savings Card has no cash value and will not be accepted outside of participating pharmacies in the United States. Please visit Galderma’s website for our privacy practices. Galderma reserves the right to revoke or amend this offer without notice at any time and to deny payment for noncompliance with the terms of this offer.

Use of this Patient Savings Card is subject to applicable state and federal law, and is void where prohibited by law, rule or regulation. In the event an AB rated generic equivalent product becomes available for one of the Galderma products covered by this Patient Savings Card, this offer will become void in Massachusetts with respect to that Galderma product.

By using the Galderma CareConnect Program Patient Savings Card, you acknowledge that you currently meet the following eligibility criteria:

  • You have a valid prescription for the Galderma product your copay and the savings apply to;
  • You have no insurance or are subject to a private insurance copay Requirement for your prescription;
  • You are not enrolled in Medicare Part D, Medicaid, Medigap, VA, DOD, Tricare, or any other government-run or government sponsored health care program with a pharmacy benefit;
  • You are at least 18 years old; and
  • You reside in the United States.