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.