Document Detail

Treatment With a Novel Topical Nanoemulsion (NB-001) Speeds Time to Healing of Recurrent Cold Sores.
MedLine Citation:
PMID:  22859243     Owner:  NLM     Status:  In-Data-Review    
Background: Current topical therapies for cold sores are only marginally beneficial due to poor skin penetration. We assessed the safety and efficacy of a novel topical antiviral nanoemulsion (NB-001) with high tissue bioavailability. Objectives: The primary endpoint was the time to lesion healing. Methods: 482 subjects with recurrent cold sores were randomized to self-initiate treatment with either vehicle or NB-001 (0.1%, 0.3% or 0.5%) at the first signs or symptoms of a cold sore episode. Lotion was applied 5 times per day, approximately 3 to 4 hours apart, for 4 days. Time to lesion healing was correlated with NB-001 bioavailability determined in human cadaver skin. Results: Subjects treated with 0.3% NB-001 showed a 1.3-day improvement in the mean time to healing compared to vehicle (P=0.006). This was consistent with human cadaver skin data indicating that the 0.3% nanoemulsion had the highest bioavailability, compared to 0.1% and 0.5% emulsions. No significant safety or dermal irritation concerns or systemic absorption were noted with any of the doses. Conclusions: Topical NB-001 (0.3%) was well tolerated and highly efficacious in shortening the time to healing of cold sores. The improvement in time to healing was similar to that reported for oral nucleoside analogues, but without systemic exposure. Topical agents for recurrent herpes labialis (cold sores) reduce healing time by one half day, compared to oral therapies that speed healing by a day or more. A topical antiviral nanoemulsion was well tolerated and improved cold sore healing time by over a day compared to vehicle control. Nanoemulsion (NB-001) could represent a more efficacious topical treatment for recurrent cold sores. J Drugs Dermatol. 2012;11(8):970-977.
Leon Kircik; Terry M Jones; Michael Jarratt; Mary R Flack; Marian Ijzerman; Susan Ciotti; Joyce Sutcliffe; Guy Boivin; Lawrence R Stanberry; James R Baker
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of drugs in dermatology : JDD     Volume:  11     ISSN:  1545-9616     ISO Abbreviation:  J Drugs Dermatol     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-08-03     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101160020     Medline TA:  J Drugs Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  970-7     Citation Subset:  IM    
Physicians Skin Care, PLLC, Louisville, KY, Mount Sinai Medical Center, New York, NY, and Indiana University School of Medicine, Indianapolis, IN J&S Studies, Inc., College Station, TX; DermResearch, Inc., Austin, TX NanoBio Corporation, Ann Arbor, MI Centre Hospitalier Universitaire de Québec, Quebec, Canada Columbia University College of Physicians and Surgeons, New York, NY University of Michigan, Ann Arbor, MI.
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