Recurrent Herpes Labialis Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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