November 2015 | Volume 14 | Issue 11 | Feature | 1371 | Copyright © 2015
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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Envy Adds Third Generation SilkPeel
Envy Medical has added the third generation of their SilkPeel system. The third generation of the system is said to deliver a “state-of-the-art Dermalinfusion treatment” via aClarityMD infusion (salicylic acid and solubized bakuchiol) that is used for acneic skin and a Lumixyl peptide solution used for brightening/discoloration.
Unveiled in 2005, SilkPeel is celebrating its 10th anniversary in style with fresh features, enhanced functionality and a sleek new design. During the past decade, SilkPeel’s distribution has expanded to more than 40 countries, with 3,000 systems in use worldwide.
SilkPeel3 is an advancement in ease-of-use, functionality, and efficacy, contended the company. A SilkPeel3 Facial costs approximately $125-150, and is available at select spas, medical spas, and dermatologist offices nationwide. It is sleeker, more compact, and has an innovative "IndiviDUAL Infusion" dual-port design that loads two serum solutions at once, allowing for more tailored treatments that address multiple skin concerns. SilkPeel3 can treat blemishes, dry skin, dark spots, and a host of other common skin concerns in one session.
Additional improvements include the ergonomically improved "Plexus" hand piece with the option of new disposable medical-grade stainless steel treatment tips that make the treatment more comfortable and effective by eliminating incomplete passes and delivering more powerful and precise pneumatic vacuum results.
The new SilkPeel3 offers an even wider treatment range, expanding the system’s efficacy to multiple body applications as well.
Fotona’s Q-Switched Lasers for Advanced Pigment Removal
Q-switched lasers have long been recognized as the gold standard technology for removal of natural as well as man-made pigments (i.e. tattoo inks) from skin tissue. Using selective photothermolysis and a unique photoacoustic effect, Q-switched laser energy penetrates safely through the epidermis to break apart specific pigments, allowing them to be easily cleared from the body.
A multi-wavelength Q-switched system such as Fotona’s QX MAX, which offers four treatment wavelengths in a single system (1064 nm Nd:YAG, 532 nm KTP, 650 nm dye, 585 nm dye), provides a complete selection of wavelengths for treating pigmented and vascular lesions. For example, superficial pigmented lesions can be treated most effectively with the 532 nm wavelength, while the 1064 nm wavelength is optimal for targeting deeper lesions.
Laser wavelength must be considered when removing pigments, especially with multi-colored tattoos. To ensure safe and effective treatments, you’ll need an optimized selection of wavelengths to target a wide range of pigments. Black and blue inks respond well to the QX MAX’s 1064 nm wavelength, red and brown respond to its 532 nm wavelength, while other colors such as green and sky blue can be more effectively treated with the 650 nm and 585 nm wavelengths, respectively.
News from Solta
Solta Medical, a division of Valeant Pharmaceuticals North America LLC announced the availability of the Clear + Brilliant pelo™ laser in the United States, a sophisticated approach to permanent hair reduction. The launch of this device, which joins the comprehensive portfolio of Solta Medical's aesthetic device solutions, follows a unique partnership with German Medical Engineering, (GME), a sophisticated leader in the development of high-performance aesthetic energy devices.
The Clear + Brilliant pelo laser system uses a novel linear scanning approach with integrated contact cooling to deliver the effectiveness of current best-in-class diode laser hair removal technology with the fastest and largest treatment area available (50mm by 15mm). In addition, a unique all-inclusive subscription model will provide ease-of-mind and simplicity in ensuring consistent device performance and dependable support.
ZELTIQ Receives FDA Clearance to Treat Submental Fat With Coolsculpting Procedure
ZELTIQ® Aesthetics, Inc. announced that it received an expanded clearance from the U.S. Food and Drug Administration, paving the way for introduction of the new, CoolMini™ applicator, which is designed to treat smaller pockets of fat, including the submental area. The applicator's size, shape, and curvature is designed to comfortably fit these small, problem areas. Patients may see results as early as 3 weeks, with the most dramatic results generally observed 1-3 months following treatment.
The FDA clearance is based on data from a U.S. pivotal clinical trial involving 60 male and female patients, ranging in age from 22 to 65 years. In the trial, patients received 1-2 treatments in the area under the chin, each six weeks apart, resulting in an average of 20% fat reduction, which is in line with results achieved with other CoolSculpting applicators. Additionally, no significant adverse events were observed and patients experienced little to no discomfort or downtime.
CleoPen for Collagen Induction
The CleoPen (a division of RBELL Medical LLC) is set to break new ground in regenerative medicine, particularly in the areas of scar treatment, fine line and wrinkle reduction, and medical tattooing, among other applications. The device represents the next step in the evolution of collagen induction therapy, a proven technique for encouraging the structural restoration of skin.
The CleoPen distinguishes itself in terms of its versatility and optimization of well-researched, effective aesthetic procedures. The device also allows practitioners to add platelet rich plasma (PRP) therapy to their aesthetic procedure toolset; PRP is a recently developed approach that uses the patient's own blood to synthesize an effective and safe dermal filler.
LEO Pharma Inc. Announces FDA Approval of Enstilar® for Plaque Psoriasis
LEO Pharma Inc announced that Enstilar® has been approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis in adults 18 years of age and older.
Enstilar® is a once-daily, alcohol free foam formulation in a pressurized spray can that allows application across large body areas of plaque psoriasis. In the pivotal Phase 3 clinical trial, over half of patients treated with Enstilar® were "Clear" or "Almost Clear" by week 4 as assessed by the Investigator Global Assessment (IGA) score of disease severity. Additionally, more than half of patients treated with Enstilar® achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline. Adverse reactions were reported in less than 1% of patients treated and included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerabation of psoriasis.