Clinical Trial: A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).

Detailed Summary:

This is a randomized, double-blind, two arm, parallel-group, vehicle-controlled, multi-center study of NB-001. The study is designed to demonstrate the safety and efficacy of NB-001 in subjects with RHL. Approximately 850 subjects who meet all eligibility criteria will be randomized in the study. Subjects will begin treatment as soon as they experience the onset of cold sore symptoms. Treatment will be applied 5 times daily, approximately 3-4 hours apart while awake. Treatment will continue until the investigator assesses the primary lesion complex as healed or a maximum of 4 days.

Clinic visits will occur on a daily basis until the investigator determines that the primary lesion complex has healed or a maximum of 15 clinic visits. At daily clinic visits, the investigator will make efficacy assessments of the primary lesion complex; safety and tolerability assessments of NB-001 following topical administration will also be assessed daily. Subjects will make daily assessments of therapy.

At the End of Study, the investigator will make a global assessment of therapy. The subject will make global assessments of therapy and social impact.


Sponsor: NanoBio Corporation

Current Primary Outcome: Time of Healing of the primary lesion complex [ Time Frame: Median time to healing (day 1 until up to 4 days) ]

Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. Time to healing is the time from application of the first dose 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: First Post-Treatment Visit (after maximum 15 clinical visits) ]

Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. 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: March 22, 2011
Date Started: April 2011
Date Completion:
Last Updated: May 15, 2013
Last Verified: May 2013