NCT01324466

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 847 (actual)
• Sponsor: NanoBio Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Recurrent Herpes Labialis

Interventions

Type	Name	Description
DRUG	NB-001	Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
DRUG	Vehicle	Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-03-29
• Last updated: 2013-05-23

Locations

35 sites across 1 country: United States