Acne scarring

Acne can leave her marked for life

Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% reduces acne lesions and the risk of scarring for results your patients can see.1

Patients at All Levels of Acne Severity Can Suffer Scarring2,3

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

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

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

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 ingredients.11
  • Not sensitive to pH variations.11
  • Polymer network maintains suspension of both components.11
  • Stabilizes adapalene and BPO and optimizes tolerability.11
  • Non-greasy and occlusive properties.11
     

Effectively Treated Inflammatory Acne Lesions

Epiduo® Forte Gel significantly reduced inflammatory lesion count over 24 weeks during the OSCAR study.4 Early onset of action was observed with a statistically significant difference as early as Week 1 and at every study visit through Week 24.4

Complementary Actions Can Make a Difference

In the OSCAR Study, the percentage of subjects rated clear or almost clear with Epiduo® Forte Gel significantly improved compared to vehicle at all study visits.4 More than three times as many subjects were clear or almost clear at Week 24.4 


Proven Tolerability: Erythema

In the safety population,* local tolerability scores (erythema, dryness, scaling, stinging/burning) were assesed at each study visit (N=217)12. The local tolerability profile of Epiduo® Forte Gel was comparable to that of Epiduo Gel 0.1%/2.5%.12†

Mean scores for erythema, dryness, scaling, and stinging/ burning peaked at Week 1, decreased thereafter, and were mild to moderate in severity.12

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%).

Proven Tolerability: Stinging/Burning

In the safety population,* local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each study visit (N=217)12. The local tolerability profile of Epiduo® Forte Gel was comparable to that of Epiduo Gel 0.1%/2.5%12†.

Mean scores for erythema, dryness, scaling, and stinging/ burning peaked at Week 1, decreased thereafter, and were mild to moderate in severity.12 

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%).
 

Proven Tolerability: Dryness

In the safety population,* local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each study visit (N=217)12. The local tolerability profile of Epiduo® Forte Gel was comparable to that of Epiduo Gel 0.1%/2.5%12†.

Mean scores for erythema, dryness, scaling, and stinging/ burning peaked at Week 1, decreased thereafter, and were mild to moderate in severity.12 
 

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%).

Proven Tolerability: Scaling

In the safety population,* local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each study visit (N=217)12. The local tolerability profile of Epiduo® Forte Gel was comparable to that of Epiduo Gel 0.1%/2.5%12†.

Mean scores for erythema, dryness, scaling, and stinging/ burning peaked at Week 1, decreased thereafter, and were mild to moderate in severity.12 

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%).

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.12


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

Routine Matters.

myForte can help.

Introducing myForte

The myForte app helps your patients keep track of their progress with the Epiduo® Forte Gel daily regimen. With myForte, patients can:

  • Learn how to use the Epiduo® Forte Gel treatment
  • Track their progress with photos and feelings
  • Receive daily skin care and lifestyle tips
  • Stay motivated with reminders
Download the myForte toolkit for in-office tools and learn how this all-new app can help your patients stay on track.
Epiduoforte Product

Easy Access To The #1 Prescribed

This patient savings program*† simply isn’t like other programs. The prescriptions you write can be easily filled by any participating pharmacy and your commercially-insured patients can pay less out-of-pocket. Easy enough?  

  • Commercially insured patients pay $0
  • Uninsured patients pay $75 (for a 3-month supply)
  • No activation is required and can be used at any participating pharmacy

Patients can download a Patient Savings Card at GaldermaCC.com.

Epiduo Forte Gel Application Instructions

  1. Patients should wash their face with a gentle, non-soap cleanser like Cetaphil® Pro Oil Removing Foam Wash.
  2. Dry without scrubbing, using a soft towel.
  3. Spread a pea-sized amount of Epiduo Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% in a thin layer over the affected areas of the face. Avoid eyes and lips and other areas where skin is thin like the inside of your nose.

    Remind patients to wash their hands after applying Epiduo Forte Gel, and to wait for the gel to dry completely before getting dressed.
  4. Apply a gentle moisturizer, preferably one with SPF protection, during the day like Cetaphil® Pro Oil Absorbing Moisturizer with Sunscreen Broad Spectrum SPF 30.

PDF Resources

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.

Indication: EPIDUO® Gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (≥1%) in patients treated with EPIDUO® Gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. Warnings/Precautions: Patients taking EPIDUO® 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® Gel and may necessitate discontinuation.

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. 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. 14. Acne 2018 Speaker Deck. Data on file. Galderma Laboratories, L.P. 15. Onexton Prescribing Information. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC; 2016. 16. Aczone Prescribing Information. Irvine, CA:  Allergan, Inc; 2016. 17. Clindagel Prescribing Information. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC; 2017. 18. Epiduo Forte Prescribing Information. Fort Worth, TX: Galderma Laboratories, L.P;  2015. 19. Gollnick H, Cunliffe W, Berson D, et al. Management of acne: a report from a global alliance to improve outcomes in acne. J Am Acad Dermatol. 2003;(49)1:S1-S37.

*Galderma CareConnect is only available for commercially insured or uninsured patients. Patients who are enrolled in a government-run or government-sponsored healthcare plan with a pharmacy benefit are not eligible to use the Galderma CareConnect Patient Savings Card.

†Restrictions apply. Please see Galderma CareConnect Patient Savings Card for details.

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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