A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)
- Registration Number
- NCT01324466
- Lead Sponsor
- NanoBio Corporation
- Brief Summary
The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 847
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Vehicle Active NB-001 Active NB-001(0.3%)
- Primary Outcome Measures
Name Time Method Time of Healing of the primary lesion complex Median time to healing (day 1 until up to 4 days) 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
- Secondary Outcome Measures
Name Time Method Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. First Post-Treatment Visit (after maximum 15 clinical visits) 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.
Trial Locations
- Locations (27)
South Valley Dermatology
🇺🇸West Jordan, Utah, United States
Radiant Research, Inc.
🇺🇸San Antonio, Texas, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
Radiant Research, Inc. Chicago
🇺🇸Chicago, Illinois, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Utah Clinical Trials, LLC
🇺🇸Salt Lake City, Utah, United States
Paramount Clinical Research
🇺🇸Bridgeville, Pennsylvania, United States
Benchmark Research - San Angelo
🇺🇸San Angelo, Texas, United States
Research Across America
🇺🇸Dallas, Texas, United States
Axis Clinical Trials
🇺🇸New Hyde Park, New York, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
National Clinical Research
🇺🇸Richmond, Virginia, United States
DermResearch
🇺🇸Louisville, Kentucky, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Radiant Research, Inc
🇺🇸Pinellas Park, Florida, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Commonwealth Biomedical Research
🇺🇸Madisonville, Kentucky, United States
Altus Research, Inc.
🇺🇸Lake Worth, Florida, United States
Front Range Clinical Research
🇺🇸Wheatridge, Colorado, United States
The Center for Pharmaceutical Research, P.C.
🇺🇸Kansas City, Missouri, United States
IntegraTrials, LLC
🇺🇸Arlington, Virginia, United States
Staywell Research
🇺🇸Northridge, California, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
Dermatology & Laser Center NW
🇺🇸Bellingham, Washington, United States