Galderma Announces Positive Results from the “CoMMPlete” Regimen Study Including Epiduo® Gel in the Management of Acne in Adolescent Student Athletes

Sigue a La Raza en Facebook

Young athletes need take extra precaution to safe guard their skin
health, as 8 out of 10 of pre-teen and adolescent teens will encounter
some form of acne as a natural side effect of puberty
1

FORT WORTH, Texas–(BUSINESS WIRE)–Galderma Laboratories, L.P. today announced the results of the
open-label single center study that evaluated the acne regimen comprised
of Epiduo® (adapalene /benzoyl peroxide) Gel, 0.1%/2.5%, the #1
prescribed branded topical acne agent in the world,2 which
uses two antibiotic-free medicines for the treatment of acne, plus
Cetaphil® DermaControl™ Face Wash and Cetaphil® DermaControl™
Moisturizer SPF 30 (referred to as the CoMMPlete Regimen). It was shown
that the CoMMPlete Regimen was safe, effective and scored high in
patient satisfaction for the treatment of acne vulgaris in adolescent
student athletes.3 The data was presented at the 74th
American Academy of Dermatology (AAD) annual meeting in Washington, D.C.


The eight (8) week study evaluated the effectiveness of the CoMMPlete
Regimen study on Texas University Interscholastic League (UIL) student
athletes (N=28), ages 12-18, with mild to moderate acne. The results
showed significantly reduced lesion counts compared to baseline (total,
inflammatory, and noninflammatory lesions; P<.001) at week 8, a 29.6%
mean change in total lesion count.3 Reduction in lesion
counts were seen as early as week two in inflammatory lesions and total
lesion counts, 11.1% and .05% respectively.3

Participants also reported good tolerability,3 minimal skin
irritation3 and patient satisfaction3 when
adhering to the acne regimen.

“The combination of Epiduo Gel, plus Cetaphil DermaControl Face Wash and
Moisturizer with SPF 30 exhibited improvement,3” said Dr.
Edward Lain, MD, MBA, lead study author and Galderma consultant. “This
data has successfully shown the benefits of a skincare regimen to
effectively treat acne vulgaris in young athletes.3

Many teens and pre-teens will experience various degrees of acne due to
the hormonal swells provoked by puberty.4 However, for
adolescent athletes, skin irritants such as heat, moisture, friction and
foreign cells,5 such as dirt and sweat, can obstruct the
openings of microscopic exocrine glands, increasing the likeliness of
frequent breakouts.1 Athletic equipment, such as helmets,
pads and tight clothing or uniforms, can often increase the occurrence
of acne.5

Acne is the most common skin condition in the U.S., affecting 40-50
million Americans nationwide.1 Epiduo Gel is the #1
prescribed branded topical acne agent in the world,2 using
two antibiotic-free medicines for the treatment of acne.6 For
patients with mild to moderate acne, Epiduo Gel works to help treat
current breakouts quickly and help prevent future pimples from forming.6

“At Galderma, we understand the impact acne has on various aspects of
patients’ lives, especially among the pre-teen and teenage population,”
said Miles Harrison, President and General Manager of Galderma
Laboratories, L.P. “We are committed to science based skin health
treatment options and helping patients manage and maintain skin health
through an effective skin care regimen.”

About Acne

Acne is the most common skin condition in the United States, affecting
more than 40 to 50 million people.1 Acne appears when pores
clog with dead skin cells,1 and can have a wide-ranging
negative impact on sufferers that includes both emotional and physical
scars.7 Acne not only affects teenagers but also can be seen
in men and women of all ages8 with research showing that the
onset of acne is frequently seen in prepubescent patients.9

When it comes to acne treatment, long-term use of antibiotics may be a
contributing factor to the overall global antibiotic resistance issue.10
Propionibacterium acnes (P. acnes), a bacteria linked to acne, is
increasingly becoming resistant to topical and oral antibiotics,10
which may potentially cause a decrease in treatment efficacy against
acne.10

About Galderma

Dating back to 1961, Galderma is now present in 100 countries with an
extensive product portfolio to treat a range of dermatological
conditions. The company partners with health care professionals around
the world to meet the skin health needs of people throughout their
lifetime. Galderma is a leader in research and development of
scientifically-defined and medically-proven treatment options for the
skin, hair and nails.

Strategic brands in the U.S. include Epiduo® Gel, Epiduo® Forte
Gel, Oracea® Capsules, Clobex® Spray, Differin® Gel, Mirvaso® Gel,
MetroGel® Gel, Soolantra® Cream, Vectical® Cream, Tri-Luma® Cream,
Cetaphil®, Benzac® Acne Solutions, Restylane®, Restylane® Silk,
Restylane® Lyft, Dysport® (abobotulinumtoxinA) and Sculptra® Aesthetic.

All trademarks are the property of their respective owners.

Important Safety Information
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.

Additional information on Epiduo Gel can be found in the prescribing
information at www.epiduo.com.

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.

References

  1. American Academy of Dermatology. Acne. https://www.aad.org/media/stats/conditions.
    Accessed on February 22, 2016.
  2. Internal calculation, IMS MIDAS, Prescription Bound, MAT Q4 2014, in
    units & in value (LCD MNF).
  3. Adams, B., et al. Adolescent Student Athletes: Efficacy, Safety, and
    Satisfaction with a Combined Acne Regimen of Adapalene and benzoyl
    peroxide (A/BPO) Gel, 0.1%/2.5% and Acne Specific Moisturizer with
    Sunscreen and Foam Wash for the Treatment of Acne Vulgaris. Presented
    at the American Academy of Dermatology Annual Meeting. Washington,
    D.C. 2016.
  4. National Institute of Arthritis and Musculoskeletal and Skin Diseases.
    What Is Acne? http://www.niams.nih.gov/Health_Info/Acne/acne_ff.asp.
    Accessed February 22, 2016.
  5. American Academy of Dermatology. Skin in the game: Dermatology issues
    among athletes. https://www.aad.org/media/news-releases/skin-in-the-game-dermatology-issues-among-athletes.
    Accessed on February 22, 2016.
  6. Epiduo [prescribing information]. Galderma Laboratories, L.P.; Fort
    Worth, TX
  7. American Academy of Dermatology. Acne. https://www.aad.org/dermatology-a-to-z/diseases-and-treatments/a—d/acne.
    Accessed on February 22, 2016.
  8. American Academy of Dermatology. Acne. https://www.aad.org/dermatology-a-to-z/diseases-and-treatments/a—d/acne.
    Accessed on February 22, 2015.
  9. Goldberg JL, et. al. Changing Age of Acne Vulgaris Visits: Another
    Sign of Earlier Puberty? Pediatr Dermatol 2011 Nov;28(6):645-648.
  10. Humphrey S. Antibiotic Resistance in Acne Treatment. Skin Therapy Let.
    2012;17(9). http://www.medscape.com/viewarticle/772258_1.
    Accessed on February 22, 2015.

Contacts

Galderma North America
Virginie Naigeon
Director of
Communications
virginie.naigeon@galderma.com
or
Twist
Mktg
Brooke Shenkin, 212-301-7202
bshenkin@w2ogroup.com