Dermatologic, Aesthetic Surgery League Formed
The Dermatologic and Aesthetic Surgery International League (DASIL), headquartered in Chicago, IL, was founded last month by Michael H. Gold, MD of the US and Marc B. Roscher, MD of South Africa, on the principle “to teach what we do best - dermatologic and aesthetic surgery.” DASIL says it will be a transparent and open society working first hand with all nations of the world's dermatologic and aesthetic surgery professionals to ensure future generations of leaders in these fields will have values that are consistent and aligned with the mission of DASIL. Among the League's programs and services, “Our planned Mentoring Program will be one of the core elements and focal points by which this will be accomplished,” says Dr. Gold. For information: theDASIL.org
Promius Acquires Cloderm
Promius Pharma has signed an agreement to market the topical steroid Cloderm (clocortolone pivalate 0.1%) Cream and will begin distribution and marketing in the US effective immediately. Cloderm is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and is available in a 45g and 90g tube, as well as in a 30g or 75g pump.
Positive Tofacitinib RA Data
Positive results from the ongoing, two-year ORAL Scan Phase III study of tofacitinib (Pfizer), an investigational JAK inhibitor, have been released. For the study, patients with moderate-to-severe RA who had inadequate response to methotrexate were randomized to add tofacitinib 5mg or 10mg BID or placebo. The data reported are from a planned analysis at one year. The study met all primary endpoints at the 10mg BID dose, showing statistically significant changes versus placebo in reducing signs of symptoms of RA, as well as reducing the progressions of structural damage and improving physical function. Tofacitinib is also under investigation for the treatment of psoriasis.
New Laser Technology May Treat Nail Fungus
New from Sciton, the ClearSense is a laser delivery technology with real-time temperature feedback for the safe and effective cosmetic improvement of dermatologic and vascular conditions, even nail fungus. The ClearToe indication is a novel intervention for onychomycosis. Other conditions that can be treated with the ClearSense include benign pigmented lesions, vascular lesions, warts, scars, wrinkles, and hair loss. Available on the expandable JOULE platform, ClearSense can be acquired as an upgrade for those who own other Sciton systems or as a single module on a standalone system.
Plaster Formulation May be Effective For Psoriasis
A plaster formulation of betamethasone valerate 0.1% (Betnovate, GSK) may be more effective in treating mild to moderate plaque psoriasis than the cream formulation, a new study finds (Am J Clin Dermatol. 12(3):191-201). Researchers randomized patients to receive BMV 0.1% plaster or BMV 0.1% cream and found that significantly more patients achieved clearing after three weeks' treatment with BMV plaster. Moreover, this difference was maintained at five weeks, with the total plaque area decreased to a larger extent for the BMV plaster group compared with the cream group. IPGA scores were significantly lower after three and five weeks' treatments with BMV plaster. There were no significant differences in adverse events between groups, the investigators noted.
First Published Account of In Vivo Mapping of NMSC
A case study documenting the successful use of Michelson Diagnostics' VivoSight optical coherence tomography (OCT) scanner for in vivo mapping of nonmelanoma skin cancer (NMSC) suggest the imaging technology can improve treatment outcomes for skin tumors (Photodiagnosis and Photodynamic Therapy, March 2011). The OCT imaging technique provides images of sub-surface tissue similar to ultrasound, but at far higher resolution, enabling the clinician to see critical details of the epidermis and dermis in realtime. In their report, researchers note that use of the new laser scanner to image skin before, during, and after PDT treatment may allow clinicians to determine whether they have successfully treated the tumor.
Pathway to Licensure
Provectus Pharmaceuticals has held its second end-of- Phase II meeting with the FDA regarding PV-10 for metastatic melanoma. The meeting addressed several topics central to the definition of the applicable patient population and primary endpoint for the planned pivotal phase III randomized controlled trial of PV-10. The agent received Orphan Drug designation for treatment of liver cancer last month.
Fibrin Sealant Associated with Reduced Wound Drainage
Results of a phase III study evaluating the safety and efficacy of ARTISS (Baxter International), a two-component fibrin sealant made from pooled human plasma, showed a reduction in wound drainage when used after facelift surgery in 75 patients. The data were reported at the American Association of Plastic Surgeons (AAPS) 90th Annual Meeting.
According to Steve Zvi Abrams, MD, Medical Director for Baxter's BioScience business, “Adjunctive ARTISS use reduced total drainage volumes at 24 hours after rhytidectomy compared with standard of care without the use of pressure dressings, which were not permitted in the study. A mean ± standard deviation volume of 7.7±7.4mL drained after 24 hours at the ARTISS-treated sides of the face, compared to a mean volume of 20.0±11.3mL at sides of the face receiving standard of care alone...Previous research has suggested that post-operative drainage can be a surrogate marker of tissue adherence and elimination of ‘dead space' between the wound bed and tissue flap,” he continued. “ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations. It offers ease of use for doctors to help deliver the product to the exact location and reduce scarring for patients without the need for staples.”
Investigators recorded seven hematoma/seroma events in five patients on the ARTISS-treated sides of the face, while eight events occurred in eight patients on the standard of care sides of the face.
Hair Restoration Society Meeting Announced
The 19th Annual Scientific Meeting of the International Society of Hair Restoration Surgery (ISHRS) will take place September 14-18, 2011, at the Dena'ina Civic and Convention Center and Hotel Captain Cook in Anchorage, AK. The theme the meeting: “New Vistas and Trusted Techniques in Hair Transplantation.” For information: www.ishrs.org.
Regenerative Medicine Company Expands
With its spray-on treatment for burns, hyper- and hypo-pigmentation, scar revisions, and aesthetic skin rejuvenation procedures (ReCell Spray-On Skin) in development, Avita Medical expanded sales and marketing operations into three new countries: Russia, The Netherlands, and Portugal. The company has commercial operations in Australia and France.
Grants Support Hemangioma, Melanoma Research
Researchers investigating the growth of hemangiomas in newborns and role of the hedgehog stem cell pathway in melanoma will each receive a grant of $10,000 from LaRoche-Posay North America Foundation. Recipients of the Foundation's 2011 Research Awards are Kathryn O'Reilly, MD (NYU Langone Medical Center) and Thanh Nga Tran, MD (Harvard Medical School).
According to Dr. Tran, “There is anecdotal evidence that early treatment of hemangioma, before or at the beginning of the proliferating phase, could limit or abort the growth of the tumor. Given the extended risk posed by systemic treatment, effective and non-invasive therapy aimed at treating infantile hemangiomas at an early state...is therefore needed in the hope of preventing significant morbidities associated with the growing lesions.” Dr. Tran is now part of a prospective, single blinded, randomized study of pulsed-dye laser (PDL) and topical timolol in the treatment of very early hemangiomas.
Dr. O'Reilly, noting that small molecule inhibitors of the hedgehog pathway are in clinical trials, says, “We aim to determine the frequency of hedgehog pathway alteration in primary and metastatic melanoma and to determine whether inhibition of the pathway induces melanoma cell death…Our studies of hedgehog signaling in melanoma may uncover additional therapeutic strategies for the subset of melanoma patients whose tumors show activation of this embryonic stem cell pathway.”