Of Dysport Challenge patients who made a selection, over 90% chose Love It!*
Of 49,042 patients who took the Dysport Challenge between March 1 and April 30, 2010, 91.2% of 18,646 patients who made a selection chose "Love It."
source: Medicis Aesthetics
FDA Approves Sculptra®Aesthetic,
A Facial Injectable for Correction of Nasolabial
Folds and other Facial Wrinkles
Click here to view press release.
Medicis Announces FDA Approval of PMA Supplement for RESTYLANE
Study Demonstrates RESTYLANE Effect Persisted Up to 18 Months in Duration in 97 Percent of Patients With One Repeat Injection
SCOTTSDALE, Ariz., Oct. 10, 2008 -- Medicis (NYSE:MRX) today announced the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement, based on clinical data which highlights RESTYLANE®'s duration effect up to 18 months in 97% of patients with repeated treatment. The RESTYLANE® package insert will be amended to include the study results. The Company anticipates using this information in its promotional activities.
About the Study
This randomized, evaluator-blinded, multi-center study enrolled 75 patients to study the safety and effectiveness of two different retreatment schedules, including duration of correction. Following a bilateral (split-face) design, each patient had both nasolabial folds corrected with RESTYLANE®. One side of the face was randomly selected to be corrected with RESTYLANE® and then re-treated at 4.5 months; the opposite side was re-treated at 9 months. Patients were evaluated using the Wrinkle Severity Rating Scale (WSRS), a five-point scale to measure visual severity of wrinkles where five is the most severe rating (extreme). Patients enrolled in the study had an initial WSRS rating of three (moderate) or four (severe).
RESTYLANE®'s effective correction of nasolabial folds persisted for up to 18 months post initial treatment, regardless of retreatment schedule. A vast majority of patients (97%) had at least one grade improvement on the WSRS at 18 months when retreated at 4.5 months. The study showed no significant difference between 4.5-month and 9-month retreatment schedules for effectiveness and safety assessment. Adverse events were primarily swelling (24%) and bruising (19%); none were serious.
The study was conducted by Rhoda S. Narins, MD, Steven H. Dayan, MD, FAS, and Frederic S. Brandt, MD.
Important Safety Considerations of RESTYLANE®
RESTYLANE® restores volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as the lines from your nose to the corners of your mouth (nasolabial folds). After your treatment, you might have some swelling, redness, pain, bruising, and tenderness. This will normally last less than seven days. Although rare, red or swollen small bumps may occur. If you have had facial cold sores before, an injection can cause another outbreak. In rare circumstances, the doctor may inject into a blood vessel, which can damage the skin. To avoid bruising and bleeding, you should not use RESTYLANE® if you have recently used drugs that thin your blood or prevent clotting. If you are pregnant, breastfeeding, or under 18, you should not use RESTYLANE®.
RESTYLANE® should not be used by people with previous bad allergies, particularly to certain microorganisms known as gram positive bacteria; by people with previous bad allergies to drugs that have required in-hospital treatment; or by people with bleeding disorders. RESTYLANE® should not be injected anywhere except the skin or just under the skin.
The use of RESTYLANE® at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. Use of RESTYLANE® in these instances could delay healing or make your skin problems worse.
RESTYLANE® is available only through a licensed practitioner. For complete product and safety information, visit www.RestylaneUSA.com.
Medicis Aesthetics Inc., the company that currently is marketing and selling RESTYLANE® and PERLANE® in the U.S., is a wholly owned subsidiary of Medicis Pharmaceutical Corporation, a leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. Medicis Pharmaceutical Corporation has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
The Company's products include the prescription brands RESTYLANE(R) (hyaluronic acid), PERLANE(R) (hyaluronic acid), DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), PLEXION(R) (sodium sulfacetamide 10% and sulfur 5%), SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets, TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide) Cream 0.05%, VANOS(R) (fluocinonide) Cream 0.1%, and ZIANA(R) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL(R) (sodium phenylbutyrate) Tablets and Powder and AMMONUL(R) (sodium phenylacetate and sodium benzoate) Injection 10%/10%, prescription products indicated in the treatment of Urea Cycle Disorder, and the over-the-counter brand ESOTERICA(R). For more information about Medicis, please visit the Company's website at www.medicis.com.
The Best of the U. S. Announces the inclusion of Jill Foster in its 2008 List of the Best (Facial Plastic Surgeons) in the U.S.
Plastic Surgery Ohio is proud to announce that Jill A. Foster, M.D., F.A.C.S. was recently selected for inclusion in The Best of the U.S.s 2008 list of the best professional in the U.S.
Plastic Surgery Ohio uses Medical knowledge to apply the latest non-invasive techniques with our surgical expertise in facial cosmetic procedures. Through your consultation with Dr. Foster we can design a program that will help you look your best.
The Best of the U.S. LLC is an independent research firm that provides a free internet search engine at BestOfUS.com that lists the Best of Class service providers throughout the United States. Those professionals included in The Best of the U.S. list have displayed an exemplary commitment to their profession, their community and to their (clients/patients). The Best of the U. S. recognizes those professionals that continue their education in an effort to stay current in their chosen profession and continue to distinguish themselves among their peers.
Know your fillers..
The Food and Drug Administration (FDA) recently gave an approving nod to the facial filler known as Radiesse. Although it has been used in doctors offices for "other than indicated" uses for many years, it has now been granted the necessary "cosmetic use" seal of approval. Primary injection sites for Radiesse include the nasolabial folds and oral commisures, with its claim to fame being longevity. Once injected, Radiesse is reported to last 12 - 18 months, which is longer that any other available dermal filler. (Information from - The Wall Street Journal - 12/27/2006)
* Tip from Plastic Surgery Ohio
Whether you decide to use a dermal filler like Radiesse, Resylane or Juverderm, consider not only who is injecting the product, but also, where is the product being injected? Know your fillers. For more information contact our office. 614-221-7464 or email us.
Jill A. Foster, M.D., F.A.C.S. awarded the Henry J. Baylis Cosmetic Surgery Award by the American Society of Ophthalmic Plastic & Reconstructive Surgeons..
The Henry J. Baylis Cosmetic Surgery Award was presented to Jill A. Foster, M.D., F.A.C.S. in recognition of her longstanding contributions in the field of cosmetic surgery. Dr. Foster has been a pioneer in the field of cosmetic facial surgery. Her keynote lecture was titled "Botox - From Deadly Nuerotoxin to Icon".
Restylane Satisfaction Study
Restylane is cross-linked hyaluronic acid that is used to fill in or "plump" wrinkles. Areas of the face where Restylane is most commonly used include the lips, nasolabial folds, melolabial folds, and undereye hollows. Data collected from patients at several ASOPRS practices reviewed complication rates and patient satisfaction of 286 patients who received Restylane. About 5% of patients after restylane injections had complications including bruising, swelling, lumps, redness, and asymmetry. More patients rated their satisfaction level as "quite high" and were more satisfied with Restylane than collagen because of a pronounced decrease in side effects and because of the longer lasting results.
1. Khan JA, McCracken MS, Wulc AE, Holds JB, Fante RG, Migliori ME, Ebroon DA, Amato MM, Silkiss RZ, Patel BCK. Hyaluronic acid gel (Restylane) filler for facial rhytids: lessons learned from ASOPRS member treatment of 286 patients. ASOPRS Fall Meeting Oct 2005, New Orleans).
Ophthalmologists have been using hyaluronic acid for more than twenty years. With increased crossed linkages, it has applications as a filler that are superior to any exogenous material that we have used in two decades. While in some cases we prefer to use autologous substances such as fat for the augmentation of deep hollows and folds, Restylane can be used to fill wrinkles and minor contour abnormalities such as acne scars, creases, folds, and hollows. It has a low incidence of complications, and is exceedingly well accepted by our patients. It lasts for at least six months, and we have seen results for up to 24 months in some patients.