Restylane for Lip Augmentation and Wrinkle Reduction
Wrinkle reduction has never been easier, thanks to development of Restylane. This revolutionary product can be used to ease the appearance of facial wrinkles – including the nasolabial folds, crow’s feet, and forehead wrinkles – enhance lip volume, and fill in facial hollows. The results are typically consistent and long-lasting, with touch-up procedures scheduled every six to twelve months in order to maintain results.
Restylane is composed of non-animal-derived hyaluronic acid, a natural component of healthy skin. Hyaluronic acid helps make up the skin’s underlying structure, contributing to elasticity and moisture. In fact, hyaluronic acid can hold 1,000 times its own weight in water.
When injected into targeted areas of the face, Restylane goes to work by increasing volume in the underlying tissue. As the volume increases, any wrinkles present begin to smooth out, much like when you blow air into a balloon. In areas where the underlying fat pads have diminished with age, Restylane can also restore a more rounded, youthful appearance.
Recovery from Restylane
Injections with Restylane can sometimes cause pain or bruising at the injection site, as well as some redness. These conditions almost always dissipate within two to three days. During this period, you should start to see the final results of your treatment appear. Side effects are rare and may be treated with injections designed to speed up the natural degradation of the hyaluronic acid. Because Restylane is not animal based, there is no allergy test required prior to use.
Frequently Asked Questions About Restylane
Q Is this a new product?
A This is a new indication for the existing Restylane product. Medicis is pleased to bring to market the first and only dermal filler FDA approved for lip augmentation in patients over 21 years.
Q What were the objectives of the pivotal clinical study used to gain FDA approval?
A The objectives of the study were to assess the safety and effectiveness of Restylane in the augmentation of soft tissue fullness of the lips.
Q How was treatment success defined in the pivotal study?
A Treatment success was defined as at least a 1-grade improvement, as assessed by a blinded evaluator at Week 8 (primary endpoint) and through Week 24 (secondary endpoints), compared to a treating investigator’s baseline assessment, using the validated Medicis Lip Fullness Scale (MLFS).
Q What was the primary outcome of the pivotal clinical study?
A At Week 8, for upper and lower lips combined, 93% (125/135) of the patients treated with Restylane experienced significant improvement (:~1 grade) in comparison to the group receiving no treatment based on the validated MLFS.
Q How long did the treatment results last?
A Using the MLFS, blinded evaluators reported that 70% of Restylane subjects maintained at least a one-grade improvement 6 months after the initial treatment.
Q How did the subjects assess their appearance after lip enhancement with Restylane?
A Using the non-validated Global Aesthetic Improvement Scale (GAlS), 74% of subjects rated their appearance as “improved” or better 6 months after initial treatment.
Q Which product(s) in the Restylane family are approved for lip augmentation?
A The FDA approval for lip augmentation was based on clinical trials using Restylane only. Restylane-L7 Periane,® and Perlane-L® are not currently approved for lip augmentation.
Q What types of adverse events were reported in the pivotal clinical trial?
A Treatment related Adverse Events (AEs) included pain, swelling, tenderness, bruising and redness. The majority of AEs reported were mild (88%) to moderate (11%) and transient in nature, resolving within less than lS days after the procedure. Restylane for lip augmentation has an acceptable safety profile, and repeat treatment did not resu lt in additional or increased adverse events.
Q What do you recommend for pain management?
A In the pivotal clinical study, the type of pain management treatment used was at the discretion of the treating physician.
Q What type of support will Medicis Aesthetics provide during the launch of the lip indication?
A Medicis Aesthetics will introduce a comprehensive set of tools to help you educate your patients on the benefits of lip enhancement. These tools will include in-office materials like patient education brochures and consultation tools as well as co-op advertising and email communications targeted to
patients. Medicis will also provide education and training for you through programs like Speaker events and Peer-to-Peer injection training.
The Restylane family of products includes Restylane, Restylane-L, Perlane, and Perlane-L. These products are indicated for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are indicated for mid-to-deep dermal implantation; Per/ane and Perlane-L are indicated for implantation into the deep dermis to superficial subcutis. Restylane is also indicated for submucosal implantation for lip augmentation in patients over 21 years.
Important Safety Information for the Restylane family of products
Products in the Restylane family contain traces of gram-positive bacterial protein and are contraindicated for patients with allergies to such material or in patients with severe allergies that have required in-hospital treatment. Patients with bleeding disorders should not use products in the Restylane family. Products should not be injected anywhere except the dermis, superficial subcutis (Per/ane and Perlane-L only), or lip submucosa (Restylane only). Restylane-L and Perlane-L should not be used in patients with hypersensitivity to amide-type local anesthetics, such as lidocaine.
Use of products in the Restylane family at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. The most commonly observed side effects are swell ing, redness, pain, bruising, and tenderness at the injection site. These are typically mild in severity and resolve in less than 7 days in nasolabial folds and less than 14 days in lips. The incidence of swelling may be higher in patients under 36 years, and the incidence of bruising may be higher in patients over 3S years. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. Do not implant into blood vessels. Use with caution in patients recently treated with anticoagulant or platelet inhibitors to avoid bleeding and bruising. Safety has not been established for use during pregnancy, when breastfeeding, or in patients under 18 years for nasolabial folds.
Treatment volume should be limited to 6.0 mL in wrinkles and folds, such as nasolabial folds, and limited to 1.5 mL per lip (Restylane only), as higher volume significantly increases moderate and severe injection site reactions. The safety or effectiveness of treatment in areas other than nasolabial folds and lips (Restylane only) has not been established in controlled clinical studies.
The Restylane family of products is available only through a licensed practitioner. Complete product and safety information is available at www.RestylaneUSAcom.]
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