Overview

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

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
NanoBio Corporation
Treatments:
5- ((2- (6- Amino- 9H- purin- 9- yl) ethyl) amino) - 1- pentanol
5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol
Criteria
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.