Chances are you've either had BOTOX done or you've heard of it - it is often brought up as controversial points in the press such as: Who is too young for BOTOX? or Which celebrity has gotten BOTOX done? Love it or hate it, the business of botulinum toxin is booming and BOTOX is at the forefront of the anti-wrinkle injectable race. Dysport, another botulinum neurotoxin was FDA approved in June of 2009 but BOTOX still has the strong hold in the market. Could a new contender, PurTox be the first to give BOTOX a run for it's money?
Recently at the Aesthetic Plastic Surgery Symposium, plastic surgeons and industry leaders gathered to discuss the next generation of anti-aging and technology. One of the keynote speakers, Dr. Brian Kinney, assistant professor of plastic surgery at USC in Los Angeles and renowned reconstructive plastic surgeon, was one of the 12 investigational sites that just completed the Phase 3 FDA clinical trials for PurTox.
"We moved into the phase 3C clinical trials with six or seven hundred patients in 12 different centers," as Dr. Kinney describes the final FDA tests for PurTox, "We completed that patient study in March and April. It was a three year study and the best study I've ever done on patients. People love it."
Currently unavailable in the market, PurTox, created by Mentor Corporation, will be a direct competitor to BOTOX as it is being evaluated by the FDA for the reduction of glabellar rhytides or the frown lines between the eyebrows. Similar to BOTOX, testing and pending approval is based on just the the glabella region. However, off label usage may prove just as effective as off-label usages of BOTOX have shown.
Patients of the study received either PurTox or a placebo in the first part of the Phase 3 trials. "We did a comparison of the PurTox for wrinkles in the glabella region, comparing that to the placebo which was saline," says Dr. Kinney.
Using a stringent rating system, Dr. Kinney and his team use high resolution photography to ensure the most accurate results are being captured. Dr. Kinney states, "Month after month, we took high resolution close-up photography with patients' heads in a grid with a standardized camera and color correction computer system. These are real photos which are independently evaluated by an outside source. When I look at my PurTox patient photos, I'm looking at their pore size and their wrinkles, or lack thereof, to objectively assess the product."
Early results have been favorable however, PurTox will not be available in the U.S. until late 2012.