Women's Rogaine 5% Receives FDA Approval
The FDA has approved Women's Rogaine 5% Minoxidil Topical Aerosol, a once-daily use treatment for Female Pattern Hair Loss. The product penetrates into the scalp, with gentle massaging to reactivate hair follicles and stimulate hair regrowth. Clinical studies show that with once daily use of Women's Rogaine 5% Minoxidil Topical Aerosol for 24 weeks, 81 percent of women regrew hair, with initial results as early as 12 weeks and new hairs coming in up to 48 percent thicker than before, according to manufacturer McNeill-PCC.
Promius Pharma Launches Promiseb Topical Cream 60 Gram Option
Promius Pharma LLC launched Promiseb Topical Cream in a new 60-gram tube. According to the company, Promiseb has demonstrated both anti-inflammatory and antifungal properties. It is indicated to manage and relieve signs and symptoms of seborrheic dermatitis. The new 60-gram box provides an option for treatment of larger body surface areas, which may necessitate fewer refills.
FDA Clears Syneron Candela's PicoWay Laser for Tattoo Removal
The FDA granted 510(K) clearance to Syneron Candela's PicoWay picosecond device for tattoo removal. PicoWay is a dual wavelength device (1064nm/532nm) that incorporates picosecond (one trillionth of a second) pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin. The high-energy ultra-short picosecond laser pulse creates a strong photomechanical impact that optimizes fracturing of tattoo ink. In a larger multicenter study, 86 percent of patients achieved at least 50 percent tattoo clearance after only three treatments based on blinded, independent review. Device treatment also presented a favorable safety profile with no device-related serious adverse events, and low levels of pain or discomfort throughout the study. The FDA clearance is for all tattoo colors: red, yellow, and orange for the 532nm wavelength; black, brown, green, blue, and purple for the 1064nm wavelength.
FDA Committee Recommends Approval of Secukinumab
The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the FDA voted 7 to 0 to support the approval of AIN457 (secukinumab), a selective interleukin- 17A (IL-17A) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. The recommendation is based on the safety and efficacy outcomes from 10 psoriasis Phase II/III clinical studies which included nearly 4,000 patients with moderate to severe plaque psoriasis.
The Phase III clinical program for secukinumab included four placebo-controlled pivotal studies that examined secukinumab 300mg and 150mg in patients with moderate to severe plaque psoriasis. In these studies, secukinumab met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 responses, showing significant skin clearance at Week 12. A majority of secukinumab-treated patients who achieved PASI 75 response and IGA mod 2011 0/1 at Week 12 maintained the response at Week 52 with continued treatment.
Study: MelaFind Reduces Benign Biopsies
A new independent study suggests that use of the MelaFind device significantly reduces biopsies for benign lesions. Using MelaFind data, investigators identified 64 of 166 pigmented lesions (on 30 patients) for biopsy, and 102 were selected for continued observation. “The results showed 61 percent of the clinically suspicious pigmented lesions in an at-risk population were deferred from biopsy, indicating that MelaFind analysis may prevent overly aggressive biopsy decisions. There may also be an overall improvement in biopsy risk,” the authors noted.
Novel Molecule Promising in Hyperhidrosis Pilot Study
Outcomes of a pilot study of BBI-4000, a new compound for the topical treatment of primary axillary hyperhidrosis, support the potential for BBI-4000 to become a safe and effective treatment option for people suffering from excessive sweating. BBI-4000 is a new molecular entity from Brickell Biotech—a “soft anticholinergic” designed to be therapeutically active in the skin.
Preliminary data show that 75 percent of patients receiving BBI-4000 achieved more than 50 percent sweat reduction compared to 33 percent of vehicle patients. In addition, 67 percent of patients receiving BBI-4000 reported a substantial (≥ 2 point) improvement in Hyperhidrosis Disease Severity Scale scores, compared with 33 percent of vehicle patients. Additionally, there were no treatment-related adverse effects or discontinuations due to adverse events. Future studies are expected.
ASDS New Officers/Board Members
The American Society for Dermatologic Surgery (ASDS) announced the election of Tom Rohrer, MD as Vice President, as well as the election of three new board members during its Annual Meeting in San Diego. Elected to three-year terms on the Board of Directors are: Ashish C. Bhatia, MD of Naperville, IL, Terrence A. Cronin Jr, MD of Melbourne, FL, and Derek H. Jones, MD, of Los Angeles. All three will serve until 2017.
Dr. Rohrer is a physician at SkinCare Physicians in Chestnut Hill and an Adjunct Associate Professor of Dermatology at Brown University in Rhode Island. Dr. Rohrer is a 2010 recipient of the ASDS President's Award and as Vice President will ascend to President-Elect in 2015-16 and President in 2016-17.
The Society's newly elected officials will join President George Hruza, MD and President-Elect Naomi Lawrence, MD.
Brodalumab Outperforms Ustekinumab in Head-to-Head Trial
New findings from the Phase III AMAGINE-3 trial suggest that the investigational IL-17 inhibitor brodalumab (Amgen/AstraZeneca) may be superior to ustekinumab in treating patients with moderate to severe psoriasis. Investigators evaluated more than 1,800 patients who were randomized to receive brodalumab 210mg, brodalumab 140mg, ustekinumab, or placebo. They found that 37 percent of patients receiving a 210mg dosage of brodalumab achieved total clearance, as compared to 27 percent of patients receiving 140mg brodalumab and 18.5 percent patients receiving ustekinumab. Additionally, 85.1 percent of patients receiving brodalumab 210mg achieved PASI 75, as compared to 69.2 percent of patients on brodalumab 140mg, 69.3 percent of patients on ustekinumab, and six percent of patients receiving placebo. Serious adverse events were somewhat more common with brodalumab than with ustekinumab, but were still uncommon, according to the authors.
Researchers Present Gigapixel Whole-Body Camera
A new “gigapixel whole-body photographic camera” may provide an option for tracking changes in potentially cancerous skin lesions. Duke University researchers developed the imaging technology.
Described as “three dozen cameras in one,” the camera has a structure similar to a telescope and its eyepieces, with a precise but simple objective lens that produces an imperfect image with known irregularities. The 34 microcameras are arranged in a “dome” to correct these aberrations and form a continuous image of the scene. The exposure time and focus for each microcamera can be adjusted independently, and a computer can do a preliminary examination of the images to determine if any areas require future attention.
Although the resolution of the gigapixel camera is not as high as the best dermatoscope, it is significantly better than normal photography, allows for a larger imaging area than a dermatoscope and could be used for telemedicine, researchers said. Clinical trials are expected.
