title: Treatment with a novel topical nanoemulsion (NB-001) speeds time to healing of recurrent cold sores.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Physicians Skin Care, PLLC, Louisville, KY 40217, USA. wedoderm@yahoo.com
authors.forename: Leon
authors.initials: L
authors.lastname: Kircik
authors.forename: Terry M
authors.initials: TM
authors.lastname: Jones
authors.forename: Michael
authors.initials: M
authors.lastname: Jarratt
authors.forename: Mary R
authors.initials: MR
authors.lastname: Flack
authors.forename: Marian
authors.initials: M
authors.lastname: Ijzerman
authors.forename: Susan
authors.initials: S
authors.lastname: Ciotti
authors.forename: Joyce
authors.initials: J
authors.lastname: Sutcliffe
authors.forename: Guy
authors.initials: G
authors.lastname: Boivin
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Stanberry
authors.forename: James R
authors.initials: JR
authors.lastname: Baker
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000998:Antiviral Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D001682:Biological Availability; D002102:Cadaver; D002594:Cetylpyridinium / Q000493:pharmacokinetics / Q000627:therapeutic use; D004311:Double-Blind Method; D004655:Emulsions; D005260:Female; D006560:Herpes Labialis / Q000188:drug therapy*; D018259:Herpesvirus 1, Human / Q000187:drug effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D049329:Nanostructures / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012869:Skin Absorption; D013024:Soybean Oil / Q000493:pharmacokinetics / Q000627:therapeutic use; D013501:Surface-Active Agents / Q000493:pharmacokinetics / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004655:Emulsions; D013501:Surface-Active Agents; D013024:Soybean Oil; D002594:Cetylpyridinium