September 2012 | Volume 11 | Issue 9 | Original Article | 1133 | Copyright © 2012
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
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Spray-On Cell-Based Therapy and Leg Ulcers
The results of a multicenter, phase-2 trial that shows the efficacy of a spray-on, cell-based treatment of venous leg ulcers was published August 2 in Lancet. The study, lead-authored by Robert S. Kirsner MD, of the Leonard M. Miller School of Medicine in Miami, tested the ability of a spray-on application of growth-arrested neonatal keratinocytes and fibroblasts to self-assemble into a fibrin matrix and heal leg ulcers. The study results show a significantly greater reduction in wound area than the control group. The treatment also accelerated wound closure by an average of 21 days compared to the control group.
The study enrolled adult outpatients with up to 3 ulcers from 28 centers in the United States and Canada. The patients had at least 1 ulcer measuring from 2 cm2 to 12 cm2 in area, which had persisted for from 6 to 104 weeks. Treatment was sprayed on the wound every 7 or 14 days. The spray-applied cell therapy is dosed at 0.5 × 106 cells per mL every 14 days. The 228 participants were randomly assigned to 1 of 5 groups: vehicle alone (50 patients), 0.5 × 106 cells every 14 days (46 patients), 0.5 × 106 cells every 7 days (43 patients), 5.0 × 106 cells every 14 days (44 patients), or 5.0 × 106 cells every 7 days (45 patients). All patients were also treated with compression bandages.
This new treatment would allow for healing without a new wound where the graft is taken from, as well as immediate treatment, without the preparation time required for skin grafts.
Syneron Receives FDA Clearance for elos Plus
Syneron Medical Ltd. has announced that it has received FDA clearance for elos Plus, a next generation, multi-platform system featuring the Company's proprietary elos technology. The elos Plus can be used to treat a range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, rejuvenation of the skin's appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins, and cellulite.
The new elos Plus employs Syneron's elos® technology of optical energy and bi-polar radio frequency designed to provide safe and efficacious treatments. The system is customizable or upgradable, utilizing up to 8 aesthetic applicators, including Syneron's Sublative and Sublime applications. The system includes a 15” touch screen for the guided treatment modes for all applications. The system is also equipped with the features from recent Syneron models such as the proprietary Active Dermal Monitoring, Intelligent Feedback System (IFS), and Sublative iD.
Vichy Laboratories Introduces LiftActiv Serum 10
Vichy Laboratories has introduced LiftActiv Serum 10, a hydrating formula that combines Rhamnose in a 10% concentration with hyaluronic acid, ceramides, and antioxidant rich Vichy Thermal Water that Vichy touts as giving a powerful anti-aging treatment in a silky texture.
Vichy touts that one single drop delivers an instant smoothing effect that leaves the skin firmer, tighter, and softer. According to the company, after one month, skin is visibly transformed; with a clinically proven reduction on the appearance of facial wrinkles: eye contours, crow's feet, forehead wrinkles, and laugh lines. LiftActiv Serum 10 also provides a long-lasting lifting effect while reducing the appearance of pores. The company also states that it is gentle enough for sensitive skin.
In self-evaluations published by Vichy, immediately after applying LiftActiv Serum 10, 98% of subjects reported softer skin, 77% of subjects reported smoother-looking skin, and 87% of subjects reported more hydrated skin. After one month, 85%reported more supple skin, 71% reported more luminous skin, and 77% reported more refined pores.
In a clinical test on women aged 40 to 55 years published by Vichy, there was a significant reduction on the appearance of key problematic wrinkles including a 21.7% reduction in crow's feet wrinkles, a 17.4% reduction in forehead wrinkles, a 16.4% reduction in nasolabial fold, and a 27.3% reduction in under eye wrinkles. Vichy LiftActiv Serum 10 ($52.00) will be available beginning September 2012 at select CVS/pharmacy, Duane Reade, and Walgreens stores.
AiCuris Herpes Drug Clears Phase II Trial
AiCuris, a pharmaceutical company that was formed in March 2006 as a spin-off of the Anti-Infectives Unit of BayerHealthCare, has completed a successful double-blind, placebo-controlled phase II dose-ranging trial for the anti-herpes drug, AIC316, which can be administered orally once-daily for prophylaxis and suppression of the HSV-2 virus.
The drug AIC316 is a non-nucleosidic drug and acts via a novel mode of action targeting viral enzymes different from polymer-