Treatment Effective on 89 Percent of Patients
For Release: 09/21/2011
"This unique, painless product could greatly expand the patient population for wrinkle reduction by offering a highly effective treatment option," said Michael Kane, MD, ASPS Member Surgeon and study author. "Many patients want the benefits injectable products offer but shy away from needles."
The study examined 270 patients with moderate to severe wrinkling around the eyes. Following application of the new botulinum toxin gel, 89 percent of patients experienced a statistically significant improvement of their wrinkles.
The gel is in clinical trials and not yet approved by the U.S. Food and Drug Administration (FDA). It reduces wrinkles by penetrating the skin and relaxing the underlying muscles. It differs from other topical treatments as those do nothing to affect the underlying muscle structure of the face. The gel is applied by the physician and then wiped off using a simple proprietary cleansing procedure.
"You can't compare RT001 to a cosmetic skin cream," said Dr. Kane. "This is a drug, not a take home product. If approved, patients will only be able to undergo the procedure at a physician's office."
Dr. Kane, who is a clinical investigator on RT001, adds that more than 500 patients have been treated in 11 clinical trials with successful results. The studies show that the wrinkle reducing effect of the product last about four months, which according to published literature, is consistent with the effect of injectable treatments.
"This is a very promising product and I'm enthusiastic about the technology," said Dr. Kane. "We are finishing Phase II testing now, and Phase III studies will need to be completed before it hits the market."
The study, "Safety and Efficacy of Topical Botulinum Toxin Type A for the Treatment of Moderate to Severe Lateral Canthal Lines - A Review of the US Phase II Experience," is being presented Saturday, September 24, 1:45 p.m., at the Colorado Convention Center in Denver.
Reporters can register to attend Plastic Surgery 11 THE Meeting or arrange interviews with presenters by contacting ASPS Public Relations at (847) 228-9900 or in Denver, September 23-27, at (303) 228-8410.
Some of the procedures and technologies presented at Plastic Surgery 11 THE Meeting, such as RT001, are currently under investigation and are presented for research and educational purposes. More scientific study is needed to further determine efficacy and success rate. The ASPS and The Plastic Surgery Foundation (The PSF) do not necessarily endorse the procedures or technologies presented and recommend that any reporting of the presented information be done responsibly with full disclosure of their unproven nature.
The American Society of Plastic Surgeons (ASPS) is the world's largest organization of board-certified plastic surgeons. Representing more than 7,000 Member Surgeons, the Society is recognized as a leading authority and information source on aesthetic and reconstructive plastic surgery. ASPS comprises more than 94 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the Society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada. ASPS advances quality care to plastic surgery patients by encouraging high standards of training, ethics, physician practice and research in plastic surgery.