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

Completed · Phase 3

Conditions studied: Recurrent Herpes Labialis

In brief

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

Key facts

Study ID

NCT01324466

Run by

NanoBio Corporation

People needed

847

Starts

2011-04-01

Expected to finish

2012-01-01

Last updated by the study team

2013-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Radiant Research, Inc. — Birmingham, Alabama, United States
• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• Radiant Research, Inc — Tucson, Arizona, United States
• Providence Clinical Research — Burbank, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Staywell Research — Northridge, California, United States
• Front Range Clinical Research — Wheat Ridge, Colorado, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• Altus Research, Inc. — Lake Worth, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Radiant Research, Inc — Pinellas Park, Florida, United States
• Radiant Research, Inc. Chicago — Chicago, Illinois, United States
• DermResearch — Louisville, Kentucky, United States
• Commonwealth Biomedical Research — Madisonville, Kentucky, United States
• The Center for Pharmaceutical Research, P.C. — Kansas City, Missouri, United States
• Radiant Research, Inc. — St Louis, Missouri, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Axis Clinical Trials — New Hyde Park, New York, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• Upstate Clinical Research Associates — Williamsville, New York, United States
• Radiant Research, Inc. — Akron, Ohio, United States
• Radiant Research, Inc. — Cincinnati, Ohio, United States
• Paramount Clinical Research — Bridgeville, Pennsylvania, United States
• Omega Medical Research — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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