FORT WORTH, Texas, Jan. 29, 2015 /PRNewswire/ -- Galderma, a global healthcare company focused on skin health, today announced the launch of Restylane® Silk, the first and only dermal filler approved by the U.S. Food and Drug Administration (FDA) for lip enhancement and the treatment of wrinkles and lines around the mouth in people over the age of 21. Restylane® Silk is a smooth gel designed to restore natural youthful definition and symmetry to the lip and mouth area.
"We are proud to announce the launch of Restylane® Silk, the first and only product specifically designed to treat the lips and lines around the mouth," said Stuart Raetzman, Chief Executive Officer of Galderma Laboratories, L.P, and Senior Vice President North America. "There is strong market interest for aesthetic products that can help address the signs of aging in the smile area without resulting in an artificial or "overdone" look, and we are pleased that Restylane® Silk will satisfy this need for healthcare professionals and consumers in the U.S."
As people age, fat and collagen in the face begin to deteriorate and bone loss may occur, leading to thinner skin and more noticeable lines and wrinkles. In the lower part of the face, this often results in lost lip volume and definition and an increase in lines around the mouth.
"Many of my patients want to address wrinkles in the lip and the vertical "barcode" lines that appear around the mouth with age, but want a natural look without the extra volume," said Doris Day, M.D., NYC dermatologist. "The availability of Restylane® Silk presents a new option for these patients that not only helps smooth wrinkles and lines, but also softly restores lip shape and enhances definition without over-plumping."
In a clinical study involving 221 patients, investigators observed that 77% of patients treated with Restylane® Silk showed an improvement in lip fullness 8 weeks after treatment and 59% of treated patients maintained lip fullness six months after treatment.1
In the same study, 98% of patients treated with Restylane® Silk reported a visible improvement in the fullness of their lips 14 days after injection and 76% reported that they still had lip improvement at six months following injection.1
"The lip and perioral area is the second most common treatment area on the face, yet – until the availability of Restylane® Silk – there has not been an FDA approved filler that has been able to effectively enhance this area with truly natural-looking results," said Kenneth Beer, M.D., Director of Kenneth Beer MD PA Cosmetic, Surgical and General Dermatology in Palm Beach, Florida and an investigator in the Restylane® Silk Phase 3 registration trial. "Restylane Silk is an exciting advancement on safe, effective and proven Restylane® technology that was engineered specifically to treat the sensitive and delicate area in the lips and around the mouth. The clinical results we observed from the Restylane® Silk trial demonstrated significant improvements in lip fullness, the smoothing of wrinkles around the mouth and showed extremely high levels of patient satisfaction."
Restylane® Silk is administered by a physician or qualified healthcare professional. The product is injected into a patient's lip and/or area around the mouth in one or two sessions as needed and the process typically takes less than one hour. In the clinical study, the results of Restylane® Silk lasted approximately 6 months following treatment. The most common side effects observed following treatment with Restylane® Silk were: swelling, tenderness, bruising, pain and redness. The majority of these side effects were mild and decreased in severity within 2-7 days. These side effects have also been observed in other lip enhancement clinical trials.
Indication:Restylane® Silk is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
Important Safety Information Restylane® Silk should not be used by people with previous bad allergies, particularly to microorganisms known as gram-positive bacteria, or by people with serious allergies to drugs that have previously required in-hospital treatment. Restylane® Silk should not be used by people with bleeding disorders, a known allergy to lidocaine, or under the age of 22, or by women who are pregnant or breastfeeding.
Use at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. In these instances, product use could delay healing or make skin problems worse. After treatment, swelling, tenderness, bruising, pain, or redness may occur. These side effects are typically mild in severity and normally last less than 7 days. Restylane® Silk should not be injected into blood vessels, which can cause injury to the blood supply and damage to the skin.
Treatment volume should be limited to 1.5 mL per lip per treatment and 1.0 mL for perioral rhytid correction, as greater amounts significantly increase moderate and severe injection site reactions.
Please see complete Instructions for Use at restylanesilk.com or restylaneusa.com.
Restylane® Silk is only available through a licensed practitioner.
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 34 wholly-owned affiliates with a worldwide network of distributors and more than 5,000 employees. Galderma's extensive product portfolio is available in 80 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 19% 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. Five state-of-the-art R&D centers and five manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy. Strategic brands include Epiduo, Oracea, Clobex, Differin, Mirvaso, Rozex/MetroGel, Silkis/Vectical, Tri-Luma, Loceryl, Cetaphil, Nutraderm, Nutraplus, Metvix, Azzalure/Dysport, Restylane and Emervel.