According to Lawrence Eichenfield, M.D., chief of pediatric and adolescent dermatology at Rady Children's Hospital, San Diego and at the University of California, San Diego, "Given the nature of acne, and its direct relationship between puberty and hormones, the focus of acne treatment has been on teenagers, leaving the younger age group with limited FDA-approved treatment options.1 The onset of acne is frequently seen in preadolescent aged patients,2 and until now, dermatologists did not have access to a prescription acne product approved for this age group."
The recent approval by the FDA was based on data received after a 12-week multicenter, randomized, vehicle-controlled, double-blind pediatric study was completed that evaluated the safety and efficacy of the gel in 285 acne patients aged 9 to 11 years.

3 Results showed that:

1. Epiduo is safe and effective in this younger population known to have more sensitive skin.
2. Parents of children in the treatment group saw a near 70 percent improvement in their child's acne.

Galderma Laboratories has taken the treatment of acne even further by creating the Epiduo TAP program, an interactive and integrated performance-based platform designed to help acne patients 13 years and older stay on treatment. The significance behind this program is explained by Steven R. Feldman, M.D., Ph.D., professor of dermatology at Wake Forest Baptist Medical Center, "When we think about the demographic pediatricians and physicians treat, we can easily attribute forgetfulness, poor motivation and bothersome side effects to the list of reasons of why patients do not stay compliant to their medication.4,5,6 When a teenager is prescribed Epiduo Gel, they can enroll in the program and earn points through reporting daily medication usage among other items. Points are then redeemed for rewards. Dermatologists know that poor use of acne medication can occur anytime during treatment, and given the chronic nature of acne, a program like TAP is needed to encourage patient adherence during the entire treatment schedule.7"

Important Safety Information
Epiduo Gel is a retinoid and antimicrobial combination product indicated for the topical treatment of acne vulgaris in patients 9 years and older. The most common adverse events associated with use of Epiduo Gel are erythema, scaling, dryness, stinging and burning. In addition, in clinical trials, adverse events reported in greater than one percent of patients treated with the gel included contact dermatitis and skin irritation. Excessive exposure to sunlight and sunlamps should be avoided during treatment and use of sunscreen products and protective clothing is recommended. Concomitant use of irritating topical products (such as products containing resorcinol, salicylic acid or sulfur) should be avoided. Epiduo Gel has not been tested on pregnant or nursing women, or with the elderly. Pregnancy
Category C. Please see Full Prescribing Information.

References

1. Food and Drug Administration. Facing facts about acne. Accessed at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm174521.htm#BewareofMyths on April 3, 2013.

2. Friedlander SF, Eichenfield LF, Fowler JF Jr, Fried RG, Levy ML, Webster GF. Acne epidemiology and pathophysiology. Semin Cutan Med Surg. 2010;29:2-4.

3. Data on file, Galderma Laboratories, L.P. Zaghloul S, Cunliffe W, and Goodfield, M. Objective assessment of compliance with treatments in acne. Br J Dermatol. 2005;152(5):1015-21.

4. Koo J. How do you foster medication adherence for better acne vulgaris management? Skinmed. 2003;2(4):229-33. Fernandez-Obregon A. Azithromycin for the treatment of acne. Int J Dermatol. 2003;9(1):45-50.

5. Robeva R, Assyov Y, Romova A, and Kumanov P. Acne vulgaris is associated with intensive pubertal development and altitude of residence-a cross-sectional population-based study on 6,200 boys. Eur J Pediatr;172(4):465-71.