Recent Developments

FDA Bans 19 Ingredients from Hand Soaps

Antibacterial soaps as we know them will soon be gone from store shelves, according to a new rule from the FDA. The final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including triclosan and triclocarban. Triclosan is used in 93 percent of liquid products labeled “antibacterial” or “antimicrobial”— at least 2,000 different products, according to the FDA.

Companies will no longer be able to market antibacterial washes with these ingredients, because manufacturers did not demonstrate that they are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.

Manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products. This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in healthcare settings.

In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products—benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX)—to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.

Skin Cancer Foundation Calls for Grant Proposals

The Skin Cancer Foundation is calling for grant proposals for their 2017 Research Grant Awards Program.

Four grants of $25,000 will be awarded to research projects and clinical studies related to improving methods of skin cancer prevention, detection, and treatment. Applications are due Friday, October 14, 2016.

Researchers are invited to submit applications for one-year projects to be conducted within the dermatology departments of medical institutions in the US. Submissions will be reviewed by the Foundation’s Research Grants Committee and applicants will be notified by December 15, 2016.

Award presentations will take place at the Foundation’s Research Grant Awards Reception on Friday, March 3, 2017, in Orlando, FL. Grantees must be present at the reception to accept their awards in person.

FDA Accepts NDA for New Impetigo Treatment

The FDA has accepted Medimetriks Pharmaceuticals, Inc.’s New Drug Application (NDA) for their novel impetigo treatment, ozenoxacin cream 1%. Ozenoxacin cream is a non-fluorinated quinolone. The Prescription Drug User Fee Act (PDUFA) date for the completion of FDA’s review is June 22, 2017.

Medimetriks licensed exclusive US commercialization rights to ozenoxacin from Spanish pharmaceutical company Ferrer in March 2014 and announced the completion of the second successful Phase 3 pivotal trial in July 2015. Both Phase 3 pivotal studies demonstrated the superiority of ozenoxacin cream 1%, applied topically twice daily for five days versus placebo on both clinical and bacteriological endpoints. In the studies, ozenoxacin demonstrated superior bacteriological cure compared to placebo as early as visit two (day three to four), and showed excellent antibacterial activity against a broad range of bacteria. The studies demonstrated that ozenoxacin was safe and well tolerated in adult and pediatric populations aged two months and older.

Cetaphil Marks Fifth Year of Support for CSDF and Camp Wonder

Galderma Laboratories, L.P., makers of Cetaphil, is celebrating the fifth consecutive year of its “Meaningphil” partnership with the Children’s Skin Disease Foundation (CSDF) and Camp Wonder. Galderma and Cetaphil provide product and grants, volunteers, and sponsored activities as part of their partnership. Throughout the five-year partnership, Galderma and the Cetaphil brand have raised more than $700,000 to help support Camp Wonder, a medically staffed summer program that invites children ages seven to 16 who live with severe and life-threatening skin diseases to experience the joys of being a kid at summer camp. The week-long camp is funded by the CSDF.

Oculus Innovative Sciences Receives FDA Approval for Post-Dermal-Procedures Product

The FDA awarded Oculus Innovative Sciences, Inc. 510(k) clearance for its new post-dermal-procedures product. Under the supervision of a healthcare professional, the product is intended for the removal of foreign material including microogranisms and debris from post­dermal procedures.

“Within my practice I utilize the Microcyn Technology (hypochlorous acid or HOCl) post-procedure and have been most impressed with its ability to accelerate the healing process, manage post-procedure symptoms, and protect against secondary infections. I find these HOCl products to be safer, non-cytotoxic, and a more effective alternative to povidone-iodine and chlorhexidine. Now, with this approval from the FDA, I believe my peers will benefit from adding Microcyn-based products to their treatment protocols,” said Michael Gold, MD, board-certified dermatologist and cosmetic surgeon, and founder of Gold Skin Care Center, Advanced Aesthetics Medical Spa, the Laser & Rejuvenation Center and Tennessee Clinical Research Center, all located in Nashville, TN.

Oculus’ dermatology division, IntraDerm, will begin marketing the post­dermal-procedures product in the United States beginning in March 2017.

Freedom Laser Therapy Launches iRESTORE Hair Growth System

Freedom Laser Therapy is rolling out the iRestore Hair Growth System. The hands-free iRestore Hair Growth System is FDA-cleared for hair growth. It works via lasers and light-emitting diodes that stimulate miniaturized and dormant hair follicles. iRestore can help maintain results and promote accelerated healing after a hair transplant as well as in conjunction with drug-based hair loss treatment methods to maximize results.

The iRestore Laser Hair Growth System is available online on Amazon and through mail order catalog websites such as Sharper Image, beauty stores, laser hair therapy clinics, hair transplant clinics and high-end hair salons for around $595.

23andMe Data Helps ID BCC Risk Genes

New research out of 23andMe and Stanford University School of Medicine pinpoints 31 genetic associations for basal cell carcinoma (BCC), 14 of which are all new. Taken together, these associations are estimated to explain almost 11 percent of the genetic risk for BCC, according to the study, which appears in Nature Communications.

The study follows another recent 23andMe and Stanford study that focused on squamous cell carcinoma. Both studies were carried out using data from 23andMe customers who consented to participate in research and had reported having either basal cell carcinoma or squamous cell carcinoma. The new findings were confirmed via data from the Nurses’ Health Study and the Health Professionals Follow-Up Study.

In the new study, regions associated with basal cell carcinoma appeared to exert a greater effect in younger individuals, suggesting that environmental factors for basal cell carcinoma might become more influential with age. What’s more, there was a significant interaction between a genetic marker in a gene called LPP and hair color, specifically light brown and dark brown/black hair groups. This suggests that the LPP marker is exerting a bigger effect on BCC risk for in people with brown or black hair. Genetic associations were found in gene regions involved in maintaining telomeres, regulating the immune system and tumor progression, as well as those already thought to regulate skin cells.

Merz Acquires Aesthetics Medical Device Company ON Light Sciences

With its newest acquisition of ON Light Sciences, Inc., Merz North America is expanding its reach into the laser-adjacent dermatologic arena. ON Light Sciences, Inc. is a US medical device company developing technologies to enhance laser-based skin procedures including the DeScribe Transparent PFD (perfluorodecalin) patch used in laser tattoo removal. The DeScribe Transparent PFD Patch is placed over tattoos prior to irradiation, allowing physicians to treat tattoos more efficiently by enabling rapid multiple laser passes in a single treatment session. It also provides significant optical clearing of tissue, protects the epidermis, and inhibits potentially infectious back-splatter and fumes.

Current OLS customers should continue to place product orders via the ON Light Sciences’ website at www.onlightsciences.com.