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

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

Detailed Description
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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.

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

Conditions
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Recurrent Herpes Labialis

Intervention / Treatment
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* Drug: NB-001
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study. Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months; Have the majority of their cold sore recurrences preceded by a well defined history of prodromal symptoms. Exclusion Criteria: Subjects with severe chronic illness Received (within the last 6 months) or receiving chemotherapy; Significant skin disease on the face Previously received herpes vaccine; Active alcohol or drug abuse; Prior randomization into any NanoBio study; Known allergies to topical creams, ointments or other topical medications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Vehicle | Drug: Vehicle<br>* Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days<br>|
| Active Comparator: Active<br>Active NB-001(0.3%) | Drug: NB-001<br>* Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Healing of the primary lesion complex | 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 | Median time to healing (day 1 until up to 4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. | 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. | First Post-Treatment Visit (after maximum 15 clinical visits) |