Acne, Acne Scarring and the OSCAR Study

The OSCAR study was a phase 4, multi-center, randomized, investigator-blinded, vehicle-controlled, intra-individual study to evaluate the efficacy and safety of Epiduo Forte Gel (indicated for the topical treatment of acne vulgaris) versus vehicle gel (n=67) in subjects with moderate to severe acne and atrophic acne scars.13 Epiduo Forte Gel was observed to be significantly superior to vehicle at all study visits starting as early as week 1, through week 24.11

Patients at All Levels of Acne Severity Can Suffer

99% of acne scars are derived from inflammatory and post-inflammatory legions.2 The OSCAR study examined the role early treatment of acne with Epiduo® Forte Gel played in helping to prevent acne scar formation.4   

99% of Acne Scars are Derived from Inflammatory and Post-Inflammatory Lesions2

Patients at all levels of acne severity can suffer from scarring, but early treatment of acne may decrease the scarring risk. 3,4 Reducing inflammation—a fundamental factor in acne scar formation—can help stop new acne from developing.2

28% of patients with almost clear skin or mild acne had scarring.3
Almost clear/mild = A few scattered comedones and a few small papules; easily recognizable; less than half of the face involved. Some comedones, papules, and pustules.4

51% of patients with moderate acne had scarring.3
Moderate = More than half of the face is involved. Many comedones, papules, and pustules. One small nodule may be present.4

77% of patients with severe acne had scarring.4
Severe = Entire face is involved. Covered with comedones, numerous papules, and pustules. A few nodules may or may not be present.4
 

Complementary Actions Can Make a Difference

Epiduo® Forte Gel contains the highest strength of adapalene available for your patients.5 The combination of adapalene and benzoyl peroxide (BPO) has multiple complementary actions.6

Adapalene

Inhibits release of pro-inflammatory mediators.7
Has low potential for irritation.7
Promotes keratinization and regulates cell turnover.7,8

BPO

Acts as an effective bacteriocide—without promoting resistance.9
BPO kills up to 99% of P acnes, a common precursor to inflammation.10
 

Proven Technology of the Simulgel Delivery System

Simulgel is a unique delivery system containing two humectants and two emollients for an ideal formulation.11 This creates an effective combination of adapalene and BPO with the unique simulgel delivery system, which does the following11:

Allows for Homogeneous dispersion of acting ingredients11
Not sensitive to pH variations11
Polymer network maintains suspension of both components11
Stabilizes adapalene and BPO and optimizes tolerability11
Non-greasy and occlusive properties11


Reducing Inflammatory Lesions Can Reduce the Risk of Scarring2

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

This chart illustrates the 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 subjects.4
 

Failure to Treat Acne with Epiduo® Forte Gel Increased the Risk of Scarring4

The graph above shows the total atrophic acne scar count for Epiduo® Forte Gel versus vehicle by visit. There were significantly more scars/% difference in amount of scars with vehicle-treated skin (ITT/LOCF).4

Lowered Risk of Scar Formation in Moderate to Severe Acne Patients

A/BPO 0.3%/2.5% vs Vehicle and Scar Formation Risk in Moderate to Severe Acne: Percent Change From Baseline - Total Atrophic Scar Count

A/BPO 0.3%/2.5% was significantly superior to vehicle at all study visits and as early as week 1

The mean number of scars decreased over time with A/BPO 0.3%/2.5%

The mean number of scars increased over time with the vehicle

The difference in mean percent change in scars (A/BPO 0.3%/2.5% vs vehicle) after 24 weeks was 29.9%


Significantly Reduced Inflammatory Lesion Counts12

OSCAR Study Treatment Results
Subject: 5029-9056 | Age: 16-year-old | Gender: male | Race: white

Significantly Reduced Inflammatory Lesion Counts12

OSCAR Study Treatment Results
Subject: 8060-9024 | Age: 18-year-old | Gender: female | Race: white

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.

1. According to data from Symphony Health Solutions, Pharmaceutical Audit Suite, Retail Audit, March 2018. 2. Epiduo® Forte Gel Clinical Study Report (SPR 105061). Data on file. Galderma laboratories, L.P. 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. Tan J, Sewon K, Leyden J. Prevalence and risk factors of acne scarring among patients consulting dermatologists in the United States. J Drugs Dermatol. 2017;16(2):97-102. 5. 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):574-581. 6. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther. 2017;7(3):293–304. 7. Leyden JJ. Topical treatment of acne vulgaris: retinoids and cutaneous irritation. J Am Acad Dermatol. 998;38(4):S1–S4. 8. Thielitz A, Sidou F, Gollnick H. Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%. J Eur Acad Dermatol Venereol. 2007;21(6):747-753. 9. Tucker R, Walton S. The role of benzoyl peroxide in the management of acne vulgaris.  Pharm J. 2007;279:48-53. 10. Mills OH, Jr, Kligman AM, Pochi P, Comite H. Comparing 2.5%, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris. Int J Dermatol. 1986;25(10):664-667. 11. Data on file, Galderma Laboratories, L.P. 12. Epiduo® Forte Gel Clinical Study Report (SRE 18240). Data on file. Galderma Laboratories, L.P. 13. Data on File: RD.03.SPR.105061, September 2017.

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.

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