News

Practical Dermatology and DermTube's Video Coverage of the AAD's Summer Meeting in Chicago

Earlier this month, Practical Dermatology^® and DermTube brought you daily coverage of the Summer Meeting of the American Academy of Dermatology in Chicago. Hosted by Amy Derick, MD, the video coverage highlights pearls from various presentations throughout the meeting, featuring interviews with several thought leaders in the specialty, including:

• Henry Lim, MD, on sunscreens and photoprotection, including the latest on the FDA final rule, as well as the potential for systemic photoprotection.
• Alexa B. Kimball, MD, MPH, on the latest developments in the treatment of hidradenitis suppurativa.
• Steven Feldman, MD, PhD, on improving patient outcomes and boosting adherence.
• Peter Lio, MD, on new concepts in atopic dermatitis research and treatment strategies.
• Clay Cockerell, MD, on the relationship between dermatologists and dermatopathologists.
• Yolanda Lenzy, MD, MPH, on African American Hair Management, including keratin treatments and vehicle selection.
• Gary Goldenberg, MD, on the newest research and treatment pearls for actinic keratosis.
• Neal Bhatia, MD, on office relationships and politics.

To view these videos, visit DermTube.com (http:// dermtube.com/series/daily-coverage-chicago-2014/welcome- to-chicago/). And for the latest breaking news, visit DermWire.com and follow @Practical_Derm on Twitter.

FDA Approves of Acticlate Tablets from Aqua Pharmaceuticals, LLC

Aqua Pharmaceuticals' oral antibiotic Acticlate (doxycycline hyclate USP) is now FDA approved for the treatment of acne. Acticlate is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne. Acticlate 150mg tablets have two functional scores, providing several dosing options to physicians and patients. The Acticlate film-coated, round 75mg tablets and oval-shaped, dualscored 150 mg tablets are designed to be small and easy to swallow. Utilization of the latest manufacturing technology has allowed 150mg of doxycycline to be formulated in a substantially reduced tablet size for Acticlate, according to Aqua.

Promius Pharma's Physician Portal Tracks Patient Progress on Zenatane

A new web-based provider portal from Promius Pharma allows physicians to follow a patient's progress while taking Zenatane™(isotretinoin capsules USP) AB rated to Accutane. Designed to allow any authorized prescriber using the Promius Promise to obtain easy, instant access to secure patient data related to their prescriptions handled by the Promius Promise, the portal is HIPAA-secured. The portal provides a list of all patients who are enrolled in the Promius Promise program (when processed through Direct Success Pharmacy), patient demographics, dates of prescriptions received and prescription shipments, information on pending prescriptions, reports showing communication with the patients and HCP office, and a patient messaging tool.

Dermatologists Remember Richard Fitzpatrick, MD

Clinical dermatologist, researcher, and laser and skincare pioneer Richard Fitzpatrick, MD, FAAD, died July 12, 2014. Dr. Fitzpatrick's various accomplishments are detailed online: clderm.com.

“Fitz and I were friends and colleagues for 28 years. We wrote many of our papers, textbooks and clinical studies together, and we always had a fun time doing it. From being founding members of the Space Dermatology Foundation, founding SkinMedica with our partner, Kim Butterwick, to doing what others thought was impossible, collaboration made our time together exciting; although our most exciting time together was watching the Chargers beat the Raiders at Qualcomm Stadium.”
—Mitchel P. Goldman, MD

“I can't think of a single non-academic dermatologist who has influenced the field of dermatology in the way that Fitz has. His contributions ranged from lasers to cosmeceuticals and he had a business mind that led to the efficient and successful adoption of his ideas. The collegiality and professionalism he presented was something I'll never forget. We all try to be kind and helpful, but Fitz did it with ease and charm. It is one thing to have an idea, but it is entirely different to see that idea take hold and change your profession. Fitz was that and more—he will be missed greatly.”
—Joel Schlessinger, MD

“Dr. Fitzpatrick was a man of quiet accomplishment and was a genuine colleague with whom I collaborated for over 20 years. He was someone whose professional views and personal thoughts I trusted and whose insight was critical to my own professional development. Fitz was multi-dimensional in the best of ways and he worked tirelessly despite dealing with health issues over the past several years. His sense of irony and humor were very much a part of what was so attractive to all of us who knew him. No matter the event or the occasion, the setting always improved when Fitz was in the room. We will miss him very much.”
—Tina S. Alster, MD

“He had an uncompromised passion for his profession and for scientific enquiry, gave of his knowledge and his skills without hesitation, and was a role model for doctors, students, nurses, the industry, professional organizations, and virtually all who knocked on his door.”
—Penny J. Smalley, RN, CMLSO

“Dick was the guy I always looked forward to seeing and after spending time with him was really glad I did. I was constantly amazed at his creativity and great insights but mostly of his great love of life. He has made a very meaningful impact on my life and I truly grateful for that.”
—Brian Zelickson, MD

Psoriasis Foundation Awards Fellowships

The National Psoriasis Foundation awarded 12 residents and medical students each a one-year, $50,000 fellowship to study psoriasis. The fellowships aim to increase the number of scientists studying and treating psoriatic disease by encouraging promising doctors to dedicate their careers to the study of psoriasis as physician researchers. The program pairs an early-career doctor with an established psoriatic disease researcher to oversee their work. To learn more about the Psoriasis Foundation fellowship program, visit www.psoriasis. org/fellowships.

Cynosure's PicoSure Laser Cleared by FDA for Acne Scars

The FDA cleared the PicoSure picosecond laser to treat acne scars. New results from PicoSure clinical studies show a dramatic improvement in the appearance of acne scars in as little as three treatments, giving sufferers a reason to celebrate. In clinical studies, 77 percent of patients achieved greater than 50 percent improvement as graded by the physician. According to the company, these are very positive signs to restoring normal skin elasticity in the scar tissue and thus reducing the appearance of the scar.

Acyclovir Muco-Adhesive Buccal Tablet Offers A Novel Approach to Target HSV

Sitavig^® (50mg acyclovir) Muco-Adhesive Buccal Tablet (Innocutis), is a new treatment option for recurrent herpes labialis, offering a unique vehicle and delivery system. Sitavig, licensed from BioAlliance Pharma, uses proprietary Lauriad® delivery technology which delivers a high and sustained concentration of acyclovir in saliva and labial mucosa. An 8mm in diameter, 2.2- 2.6m thick tablet adheres to the gum, above the canine tooth on the side of the lip that is infected with a cold sore. The tasteless, odorless tablet dissolves in 4 to 6 hours to provide a sustained release of acyclovir.

Phase III study results demonstrate that a single low dose of Sitavig acyclovir buccal tablet improved all clinical parameters of herpes labialis. The incidence of blocked herpes episodes was increased by 24.2% (34.9% vs 28.1%; p = 0.042) in the active treatment group. During the nine-month follow up, recurrence of herpes lesions was less frequent (64.2% vs 73.6%; p = 0.027) and delayed (205 days vs 165 days, p = 0.041) in the Sitavig 50mg group compared to placebo controls.

Reduction in frequency of and time to recurrence “may be due to the rapid and high acyclovir concentrations in the basal layer of the mucosa where HSV-1 replication is most abundant ,” Dr. Downing suggests.

The new formulation may provide benefits in terms of both compliance and drug delivery, according to investigators. Therapeutic adherence is a concern with topical formulations of acyclovir. “They have to be reapplied multiple times, and reapplication may become less frequent over time,” says Christopher Downing, MD, Sub-Investigator at the Center for Clinical Studies in Houston, Texas. “This new formulation is quite innovative. It is applied to the gum just one time.”

“Patients using the product are, by definition, compliant,” adds Stephen K. Tyring, MD, PhD, clinical professor of dermatology at the University of Texas Health Science Center in Houston, Texas. “Either patients are 100% compliant or they are not compliant at all.”

Drs. Downing and Tyring participated in trials for Sitavig. Data have been published in Journal of Drugs in Dermatology.

The majority of subjects in the clinical trial had previously used acyclovir, and it was necessary to stress that they were not to swallow the tablet. It was an easy concept to explain, Dr. Tyring says, and patients easily applied the tablet as instructed. He adds that if a patient does swallow a tablet, there is no associated safety concern.

In a multicenter double blind placebo-controlled patient-initiated trial, 775 patients with recurrent HL were randomly assigned to either a single application of Sitavig 50mg or matching placebo as soon as prodromal symptoms occurred.

“This treatment is best suited for the patient who can recognize prodromal symptoms of disease and apply the treatment as quickly as possible once the syndrome is identified,” Dr. Downing says. Patients can be advised to have their prescription with them when going to the beach or ski slopes or other locations that are associated with inducing HSV flares.

Although the study did not investigate subjects who applied Sitavig during an active outbreak, Dr. Tyring believes treatment may provide benefit to patients with active herpes labialis. Furthrmore, there is no reason the formulation cannot be used in combination with standard interventions for symptom management.

Local and overall tolerance of Sitavig 50mg was acceptable in the trials. Application site irritation was slight and infrequent (<1%).

New Data Show High Efficacy for Can-Fite's CF101 in Rheumatoid Arthritis and Psoriasis Patients

New data from a retrospective analysis of its autoimmune disease advanced trials show high efficacy of Can- Fite BioPharma Ltd.'s orally bioavailable drug CF101.

The retrospective study, conducted by a third-party statistician group, analyzed the correlation between response to CF101 and patients' body mass index (BMI) in the Phase II/III Psoriasis interim results as well as the recently completed Phase II Rheumatoid Arthritis trial. The data shows a significant increase in the response to CF101 in patients with a BMI of over 25 in both studies.

These findings corroborate the efficacy seen with other FDA approved drugs such as cyclosporine A, which was more effective in patients with high BMI. The company believes these findings will enable it to optimize the design of its forthcoming Phase III studies. Can-Fite's Phase II/III psoriasis trial is ongoing with data expect to be released in the first quarter of 2015.

FDA Warns on Unapproved Use of Expression Injectable as a Dermal Filler

The FDA reported that it has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. According to the FDA, Expression is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material.

Dermatologists: Preferred Providers to Treat, Evaluate Skin Cancer

Dermatologists are overwhelmingly the preferred health care provider for evaluating and treating skin cancer, according to a study published in the June issue of Dermatologic Surgery. In an online survey conducted by the American Society for Dermatologic Surgery (ASDS), respondents were asked their choice for evaluating a worrisome lesion on the face and for removing skin cancers from the back and face. The options were a dermatologist, primary care physician, plastic surgeon, general surgeon or a physician assistant/nurse practitioner. According to the study authors, the findings shed light on the perceptions of the general public when it comes to evaluating and treating skin cancer.

Meeting Minute

CSF Adds New Faculty, Sessions
Cosmetic Surgery Forum has added new faculty members and educational sessions to its agenda. New to the podium this year will be Joel Cohen, MD, Ellen Marmur, MD, Gerald Goldberg, MD, Sabrina Fabi, MD, and Laurin Council, MD. Among the new sessions at this year's meeting is an “Invention and Intellectual Property” panel with speakers Carl Thornfeldt, MD, course director Joel Schlessinger, MD, and others. According to Dr. Schlessinger, the panel will go over the patent process, including things to avoid and tops for would-be inventors. For more information or to register, visit www.cosmeticsurgeryforum.com.

Summit on Patient-Centered Trials
On September 4-5, 2014, industry leaders will convene in Boston to discuss promoting patient empowerment in clinical research, leveraging innovation, and collaboration. The conference will open with a keynote by Ken Getz, Director of Sponsored Research at Tufts CSDD, and is cochaired by Christine Pierre, President of the Society for Clinical Research Sites (SCRS) and Andreas Koester, Vice President of Innovation and External Alliances at Janssen, Pharmaceutical Companies of Johnson & Johnson.

More Headlines from Dermwire.com

Anacor Partners with Sandoz to Distribute Kerydin
Anacor Pharmaceuticals, Inc. has entered into an exclusive agreement with Sandoz Inc., a Novartis company, pursuant to which Sandoz will distribute and commercialize Anacor's recently approved Kerydin (tavaborole) topical solution, 5% in the US. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of Kerydin, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails. The agreement with Sandoz entitles Anacor to upfront payments totaling $40 million and an additional milestone payment of $25 million expected to be paid in January 2015.

National Call-to-Action on Skin Cancer Prevention
The American Academy of Dermatology Association (AADA) recently joined with the U.S. Department of Health and Human Services' (HHS) Office of the Surgeon General and Centers for Disease Control and Prevention (CDC) to issue a national call-to-action on skin cancer prevention. The national call to action identifies opportunities for the government, public and private organizations, healthcare providers, and individuals to raise awareness of skin-protection practices.