A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS) (NCT01324466) | Clinical Trial Compass
CompletedPhase 3
A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)
United States847 participantsStarted 2011-04
Plain-language summary
The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Time of Healing of the primary lesion complex
Timeframe: Median time to healing (day 1 until up to 4 days)