Galderma's Tri-Luma® Cream, Only FDA-Approved Treatment for Melasma, Now Available in Pharmacies Clinically Proven Treatment Can Help More than 7 Million Suffering from Melasma in the U.S.

FORT WORTH, Texas, Feb. 12, 2013 /PRNewswire/ -- Galderma Laboratories, L.P.'s Tri-Luma® (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Cream, the only FDA-approved triple combination topical product indicated for the short-term (up to 8 weeks) treatment of moderate to severe melasma of the face, is now available to the more than 7 million people who suffer from this chronic skin condition.

Tri-Luma® Cream contains a clinically-proven formula which combines three active ingredients:  fluocinolone acetonide 0.01%, a mild corticosteroid that reduces inflammation; hydroquinone 4%, a de-pigmenting agent that interrupts the formation and synthesis of melanin to help lighten the skin; and tretinoin 0.05%, which works to increase the skin cell turnover rate to exfoliate skin. There is no generic equivalent.

Melasma is a common skin condition that causes the appearance of brown to gray-brown patches of skin due to the body producing too much melanin, a natural substance that gives color to skin, hair and eyes. Melasma usually appears on the face, although it can also develop on the forearms and neck. 

There are many factors that are associated with melasma including the use of birth control pills, hormone therapy, cosmetics and anti-seizure medications. Because melasma is so common during pregnancy, it is sometimes referred to as "the mask of pregnancy."  Sun exposure is also a major melasma trigger because ultraviolet (UV) light from the sun increases melanin production.  People of Latin, Asian, Indian, Middle Eastern, Mediterranean and North African descent, as well as people with a family history of melasma, are more likely to suffer from the condition.

"Tri-Luma is the only FDA-approved product containing hydroquinone 4% to treat melasma patients safely and effectively. At Galderma we engage with doctors to develop an empathetic understanding of melasma and the impact it has on patients. Our greatest satisfaction comes from the realization that Tri-Luma can actually help people and positively change their lives," explains Francois Fournier, President of Galderma's US and Canadian Operations. "Galderma is more than ever committed to delivering innovative medical solutions to meet the dermatological needs of patients throughout their lifetime while serving healthcare professionals."

"One of the most difficult hyperpigmentation disorders to treat is melasma. It is emotionally and psychologically devastating to patients and has a negative impact on their quality of life. In fact, I have had many patients who have lost their job or have avoided social situations because of the way they look and feel about their skin. In my practice, the most effective therapy that I have used has been Tri-Luma.  I am really excited that it is back," said Valerie D. Callender, MD, Medical Director, Callender Dermatology and Cosmetic Center in Glenn Dale, MD. 

"Tri-Luma is the most effective branded prescription product I have used for my patients with melasma since I began practicing dermatology more than 20 years ago.  The clinical studies performed with Tri-Luma, which led to its approval, provide the evidence dermatologists need to use this product confidently. I have had countless patients return with positive comments regarding their improvement with Tri-Luma," added Amit G. Pandya, MD a distinguished teaching professor at University of Texas Southwestern Medical Center.   

Francois Fournier stated that healthcare providers may now write prescriptions for Tri-Luma® Cream.

IMPORTANT SAFETY INFORMATION
Indication: TRI-LUMA® Cream is indicated for the short-term (up to 8 weeks) treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance, including the use of sunscreens.  Adverse Events: In the controlled clinical trials, the most frequently reported events were redness, peeling, burning, dryness, and itching at the site of application.  Warnings/Precautions: TRI-LUMA contains sulfites which may cause severe, life-threatening allergic reactions in people allergic to sulfites. TRI-LUMA contains hydroquinone, which may cause a gradual blue-black darkening of the skin.  If you are pregnant, nursing or trying to become pregnant you should not use TRI-LUMA.  Safety and efficacy have not been established in individuals with darker skin.  Reversable HPA axis (adrenal function) suppression may result from exposure to the topical corticosteroid, fluocinolone acetonide, so discontinue use if signs and symptoms of this condition occur.  Avoid products that may dry or irritate the skins, such as abrasive cleansers, scrubs, or skin-peeling agents. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided.  If exposure cannot be avoided, sunscreen products [SPF 30 or more] and protective apparel should be used.

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.

For more information about Tri-Luma® Cream, please see full Prescribing Information at TriLuma.com.

About Galderma
Galderma is a global company founded in 1981 committed to delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime while serving healthcare professionals around the world.  The company has 31 wholly-owned affiliates with a worldwide network of distributors and more than 4,000 employees. Galderma's extensive product portfolio is available in 70 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence.

With approximately 20% of revenues invested each year to discover and develop new products and access innovative technologies, the company is one of the world's leading investors in dermatology R&D. Four state-of-the-art R&D centers and four manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy. Strategic brands in the U.S. include Epiduo®, Differin®, Oracea®, MetroGel®,  Clobex®, Vectical®, Pliaglis® and Cetaphil®.

SOURCE Galderma Laboratories



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