News

Alcohol Intake Not Linked to Early BCC

Despite some trends suggesting that high alcohol use and high UV exposure may be associated with risk for early onset BCC in women, there is no statistically significant association between lifetime alcohol intake and early-onset BCC overall or in women only, new data from the British Journal of Dermatology show.

Previous epidemiological studies of overall alcohol intake and BCC have offered some evidence for increased skin cancer risk, with differences based on type of alcoholic beverage. Researchers compared BCC cases and controls with benign skin conditions under 40 years of age. Participants provided information on lifetime alcohol intake, including type of beverage, during an in-person interview. Self-reported data on indoor tanning and outdoor sunbathing were used to categorize UV exposure.

Intake of red wine, white wine, beer, or spirits and mixed drinks was not associated with early-onset BCC. While it is hypothesized that alcohol may enhance the carcinogenicity of ultraviolet (UV) radiation, this has not been evaluated in existing epidemiological studies.

Dermira and UCB Announce Start of Phase III Program for Cimzia^® (Certolizumab Pegol) in Psoriasis

Dermira, Inc., a specialty biopharmaceutical company focused on bringing innovative and differentiated medical dermatology products to dermatologists and their patients, and UCB, a global biopharmaceutical leader, announced that the first patients have been dosed in the Phase III clinical program designed to evaluate the efficacy and safety of Cimzia^® (certolizumab pegol) in adult patients with moderate- to-severe chronic plaque psoriasis. This is an important step forward in the collaboration between Dermira and UCB in the development of solutions for patients with moderateto- severe plaque psoriasis. Cimzia^® is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

Revance Therapeutics Initiates BELMONT Phase II Active Comparator Trial of Injectable RT002

Specialty biopharmaceutical company Revance Therapeutics, Inc. has initiated the BELMONT trial, a Phase II, randomized, double-blind, dose ranging, active, and placebo controlled, multi-center study to evaluate the safety and efficacy and duration of effect of RT002, a botulinum toxin type A for injection, to treat glabellar lines, more commonly known as frown lines. RT002, incorporating Revance's patented TransMTS^® delivery technology, is an investigational product designed to offer more targeted delivery of botulinum toxin to intended treatment sites with reduced spread beyond the site of local injection. Last April, Revance reported the results of a Phase I/II study that showed median duration of 29.4 weeks, which exceeds the labeled duration of currently marketed botulinum toxin products for the treatment of glabellar lines.

Vivacare Launches “Find a Dermatologist” Directory with “Expert Opinion” Function

Vivacare has launched its new Find a Dermatologist Directory (www.findadermatologist.com) to help dermatology professionals reach prospective patients and share their unique approach to patient care.

The Find a Dermatologist directory lists US-based dermatologists, dermatology physician assistants (PAs), and dermatology nurse practitioners (NPs) who have shown a commitment to patient education. Those physicians and medical providers who display Vivacare patient education content on their websites are profiled in the Directory. Dermatology professionals are also invited to share their own ‘expert opinions' regarding dermatology topics. Expert opinions that offer helpful insights for a patient audience are featured in the Directory and increase the author's visibility online.

By creating a Vivacare account, physicians or medical groups can quickly create their own free, personalized ‘Health Library' that is pre-populated with hundreds of patient handouts, videos and other resources that can be printed in the office, viewed on a mobile device, or displayed on a medical practice website. By being integrated onto a practice website, the ‘Health Library' efficiently delivers indepth health information to patients at the point of care from their own doctor.

Vivacare's newly released ‘Expert Opinion' function enables a physician to supplement the Health Library with his or her own professional perspective regarding selected topics. For instance, dermatologists may add their expert opinion regarding sunscreen, with details about which ingredients to look for and which brands to consider buying. Expert opinions provided by dermatologists are published to the Find a Dermatologist Directory to highlight the doctor's unique approach to patient care.

ASDSA Names 2014 Patient Safety Hero Award Winners

Honoring physicians and dermatologic societies whose notable efforts for greater patient safety in cosmetic procedures have made a difference last year, the American Society for Dermatologic Surgery Association (ASDSA) recently named the 2014 winners of its annual Patient Safety Hero Awards. The Minnesota Dermatological Society was honored for its work to block legislation that would have significantly weakened protections for patients undergoing laser procedures and also for helping to pass a ban on indoor tanning by those younger than 18.

Recipients of the Physician Patient Safety Hero awards were Practical Dermatology^® contributor Bruce A. Brod, MD (see page 34) and Ashley A. Smith, MD, for their work to highlight consumers' preferences for truth in medical advertising. In 2013, as part of the ASDS Future Leaders Network, Dr. Brod and Dr. Smith conducted a consumer survey of those considering cosmetic medical procedures, specifically on board certification and dermatology. The survey revealed a clear preference on the part of consumers to know the level of licensure and other information about potential providers, according to the ASDSA. Dr. Brod and Dr. Smith's work was subsequently turned into a podcast and infographic, which were the centerpiece for advocating on the issue at a New York state legislative day as well as in efforts in several other states. Both the podcast and infographic are available for download at asdsa.asds.net.

ASDS Presents Award for Outstanding Service

Melanie Palm, MD, MBA was honored for her contributions to the American Society for Dermatologic Surgery with the ASDS Award for Outstanding Service. The annual award recognizes young, emerging leaders of ASDS who have demonstrated commitment to the Society's growth and success. Nominees must have been ASDS members for fewer than 10 years and have volunteered their time and efforts in multiple capacities for a minimum of three consecutive years.

Dr. Palm, director and owner of Art of Skin MD, in Solana Beach, CA, has been active in ASDS since beginning her medical residency, said 2013-14 ASDS President Mitchel P. Goldman, MD, who presented the award. She participated as a mentee of the Society's Future Leaders Network in its inaugural year. Her project—the ASDS DermSurg Fellowship Finder database to help dermatology residents locate prospective fellowships—now is featured on the ASDS website. She is a member or former member of several ASDS work groups, including the Product and Service Development Work Group, which she chairs. Dr. Palm has been a faculty lecturer and moderator at several ASDS Annual Meetings and a faculty member for a procedural course. She contributes to Dermatologic Surgery, the journal of ASDS, and has participated in complimentary ASDS skin cancer screenings. She has won the ASDS Review Article Incentive Program and the ASDS Young Investigators Writing Competition.

Dr. Palm trained at Dr. Goldman's practice. “As a fellow, she was outstanding in every way,” he said, adding that they continue to co-author chapters of dermatology textbooks together. “She is already a leader and role model and will continue to excel.”

Promius Pharma Launches Promius Promise App

Promius Pharma, marketer of ZenataneTM (Isotretinoin Capsules USP), a generic form of isotretinoin, has created the Promius Promise App designed to help educate and guide patients through the various treatment requirements.

The Promius Promise App can be downloaded free of charge by anyone who has received a prescription for Zenatane through the Promius Promise program. It answers frequently asked questions and makes it easy for the patient to find important information, Promius says. The App acknowledges that there are many steps involved in the treatment process and outlines them with an easy-to-follow roadmap. Market research that suggested the app may be especially beneficial for young adults and teens. Promius says it can serve as a tool for parents, who may want easy access to Promius Promise information and phone numbers in the event a question arises, so they can support the isotretinoin patient in their life. Providers can also use the App to access the new secure web portal.

More Headlines from DermWire.com

Oculus Innovative Sciences Launches IntraDerm Pharmaceuticals, New Dermatology Division

Oculus Innovative Sciences, Inc., a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, has launched a new division, IntraDerm Pharmaceuticals.

IntraDerm Pharmaceuticals intends to develop and commercialize advanced dermatological products for the professional dermatology markets in the US and internationally. Headquartered in Petaluma, CA, IntraDerm Pharmaceuticals is staffed with a seasoned management and sales team well versed in the dermatology prescription markets in both the US and Europe.

For more breaking industry news, visit www.DermWire.com.

FDA Actions

Suneva Medical's Bellafill Approved to Treat Acne Scars
Suneva Medical, Inc.'s Bellafill is now the only filler on the market approved for the treatment of acne scars. FDA granted approval for Bellafill to treat acne scars based on the outcomes of a double- blinded, randomized, placebo-controlled pivotal study in which subjects were treated with Bellafill at 10 U.S. clinical centers. Bellafill was found to be a safe and effective treatment when compared to subjects treated with a Control saline injection.

The study's primary effectiveness endpoint was proven superior for subjects treated with Bellafill compared to Control at six months. A responder was defined as a subject who had 50 percent or more of treated acne scars improve by two or more points on a validated fourpoint Acne Scar Rating Scale (ASRS). At six months, the response rate for Bellafill was 64 percent vs. 33 percent for Control. Bellafill continued to show effectiveness by an unblinded assessment at 12 months.

FDA Approves Galderma's Soolantra to Treat Rosacea

The FDA approved Galderma's Soolantra (ivermectin) Cream 1% for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. Recent studies have further solidified that generally harmless microscopic Demodex mites may also be a culprit. These mites are normal inhabitants of everyone's skin, but may appear in greater numbers on the faces of people with rosacea.

In clinical studies, Soolantra Cream effects were seen as early as week two with continuous improvement in patients with inflammatory lesions of rosacea. In a separate head-tohead study with metronidazole 0.75% cream, Soolantra Cream was shown to be more efficacious from as early as week three onward. While the mechanism of action of Soolantra Cream is unknown, ivermectin, the active ingredient in Soolantra Cream, has been reported to have both anti-inflammatory and antiparasitic activity.

Celsus Therapeutics Receives FDA Allowance of IND in Atopic Dermatitis
Celsus Therapeutics will expand its clinical program in atopic dermatitis in the US, now that the FDA has allowed its Investigational New Drug Application (IND) for the clinical development of MRX-6 Cream 2% in patients with atopic dermatitis. The company plans to initiate enrollment of a Phase II double blind, vehicle controlled, dose ranging trial of MRX-6 cream testing 0.1%, 1% and 2% vs vehicle in the first quarter of 2015. The Phase II trial will test three doses (0.1%, 1% and 2%) versus vehicle to evaluate the safety and efficacy of MRX-6 cream in mild to moderate atopic dermatitis. The trial will enroll 168 patients into a four-week double-blind period. Results from this trial are expected in the first quarter of 2016.