Topical Therapy Safely Treats Serious Skin Infections

A new topical lotion that penetrates the skin deeply enough to target and eliminate serious skin infections, but without being systemically absorbed, has shown a high degree of safety and tolerability, according to a new phase I study.

NB-002 is a topical oil-in-water nanoemulsion combined with an antimicrobial agent. The nanoemulsion undergoes a high-energy process to shrink the particles so they are small enough to enter the skin through pores and hair follicles but too large to penetrate the tight junctions of the epithelium. In a phase I study to test the product, developed by NanoBio Corporation (Ann Arbor, MI, USA) a spin-off from the University of Michigan (Ann Arbor, MI, USA), 20 subjects with advanced onychomycosis (toenail fungus) were randomized to receive two strengths of NB-002. Treatments were applied twice daily for 28 days to both affected and unaffected toenails and a small area of surrounding skin. Results showed that systemic drug absorption was below quantifiable limits for all subjects throughout the study period. Additionally, the trial showed that NB-002 had no safety or dermal irritation concerns. The study was presented at the 47th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting, held during September 2007, in Chicago (IL, USA).

"At present, the vast majority of people with onychomycosis are untreated as a result of concerns for the serious toxicities associated with the available oral medications,” said lead author James Baker, M.D., chief science officer and founder of NanoBio. "Our safety data, combined with early information from the ongoing phase 2 trial, indicate that NB-002 is potentially the first treatment for onychomycosis that is highly efficacious and very safe.”

Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail accompanied by serious pain and disability. Fungal infections of the nail bed affect 25% of adults and this rate rises with age. Systemic treatments have significant safety risks and a high relapse rate (40%). Available topical treatment, on the other hand, has a low efficacy rate (5-12%).


Related Links:
NanoBio Corporation
University of Michigan