Novel Polycaprolactone Filler Could Produce Longer-Lasting Results Vs. Traditional Fillers
A novel biostimulatory polycaprolactone (PCL)-based dermal filler could offer longer-lasting performance over NASHA-based dermal fillers in nasolabial fold treatment, according to a new report. In a randomized split-face study, researchers compared a PCL-based dermal filler with a NASHA-based dermal filler, for safety, efficacy, and duration of cosmetic correction for the treatment of nasolabial folds (NLFs). A total of 40 patients received a PCL-based dermal filler in one of their NLFs, and a NASHA-based dermal filler on the contralateral side, with researchers evaluating efficacy based on the Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale. After six, nine, and 12 months post-treatment, NLFs treated with the PCLbased dermal filler showed statistically significant improvements on the Wrinkle Severity Rating Scale and greater improvements on the GAIS compared to NLFs treated with the NASHA-based dermal filler. Both products were found to be equally safe and well tolerated.
—J Cosmet Dermatol. 2015 Jan 6.
Alphaeon Begins Phase III Study For Its Neurotoxin, Evosyal
The FDA agreed to Alphaeon Corporations’s protocol for its Phase III clinical study of Evosyal™ to treat glabellar lines. Alphaeon acquired the exclusive US and certain international distribution rights to Evosyal, a botulinum toxin type A neuromodulator, as part of its acquisition of Evolus Inc. In the last 12 months, Alphaeon has submitted its investigational new drug application for Evosyal and completed enrollment in its Phase II study. Alphaeon began enrollment of its Phase III study on January 14, 2015.
BY THE NUMBERS
1,257
The number of medical device reports made to the FDA between 1991 and 2013, according to a new study. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. Despite underreporting of adverse events, the authors note that the MAUDE database (available on the FDA website) is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports, will help raise awareness and improve patient safety.
—Lasers Surg Med. 2015 Feb 4.
TRENDING NOW
“Lips present a threedimensional challenge. That is, they have to appear like they do in real life and they have to be proportional…. In order to create lifelike and perfect lips, it’s important to understand the underlying anatomy.”
—Kenneth Beer, MD
In a recent edition of DermWireTV, Dr. Kenneth Beer shared insights on the challenges and opportunities associated with the treatment of lips and the significance of Restylane Silk, the first dermal filler for lip enhancement. See the full segment at DermTube.com
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