Clinical Trial: NB-001 Treatment of Recurrent Herpes Labialis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis

Brief Summary: This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Subjects will then be followed to assess time to healing.

Detailed Summary:
Sponsor: NanoBio Corporation

Current Primary Outcome: Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. [ Time Frame: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days) ]

Time to healing is the time from receiving the combination to unlock the medication and begin treatment to investigator assessed healing.


Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage [ Time Frame: Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days) ]

This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.


Original Secondary Outcome: Same as current

Information By: NanoBio Corporation

Dates:
Date Received: September 18, 2012
Date Started: October 2012
Date Completion: July 2013
Last Updated: June 13, 2013
Last Verified: June 2013