Head Lice Infestation:  Developing Drugs for Topical Treatment
2015-19 Head Lice Infestation Developing Drugs for Topical Treatment CDER development program clinical trial designs
2016-10-25
FDA-2015-D-4561-0006
04:00:00
https://api.regulations.gov/v4/comments/FDA-2015-D-4561-0006
Anonymous
Anonymous
I am a practicing physician and hold active licenses in 3 states. This particular guidance caught my attention because there already exists a nearly 100% safe and effective treatment for head lice utilizing an FDA-cleared medical device called the AirAlle (formerly Lousebuster). It received FDA-clearance in May of 2010. I am the medical director of Pediatric Hair Solutions which is a regional company dedicated solely to the treatment of head lice utilizing the AirAlle medical device. Pediatric Hair Solutions has 10 clinics across 4 states. We have now successfully treated more than 15,000 cases over the past 5 and 1/2 years. Rather than encouraging pharmaceutical companies to develop new potentially toxic topical treatments for head lice I would encourage the FDA to review the published data on the AirAlle medical device. The AirAlle uses heated air to desiccate live bugs as well as the eggs or nits. Researchers strongly believe that lice will not be able to develop resistance to this treatment method because the mechanism of action is water deprivation. The AirAlle kills not only live bugs but is also extremely ovicidal (it kills 99.2%) The cost of treatment is also significantly less than the cost of the popular prescription medication Sklice. Sklice is also only 70-74% effective as documented in the package insert. I would urge the FDA to review the studies referenced below and perhaps reconsider this recent guidance.1. An Effective Non-chemical Treatment for Head Lice: A Lot of Hot Air. Pediatrics November, 2006 Volume 118    Issue 5 2. Efficacy of the Lousebuster, a New Medical Device for Treating Head Lice (anoplura Pediculae) Journal of Medical     Entomology 48 (1) 67-72. 20113. A New Treatment Approach to Pediculosis Utilizing the Lousebuster TM Device and Safe Nontoxic Treatment Solutions    St. Jude Pediatric Infectious Disease Conference February 2012 Abstract #201221