A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
NCT ID: NCT01321359
Last Updated: 2013-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
907 participants
INTERVENTIONAL
2011-04-30
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vehicle
Vehicle
Vehicle versus NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Active
Active NB-001(0.3%)
Vehicle versus NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Interventions
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Vehicle versus NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Eligibility Criteria
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Inclusion Criteria
* 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 proceeded by a well defined history of prodromal symptoms.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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NanoBio Corporation
INDUSTRY
Responsible Party
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Locations
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Radiant Research, Inc
Chandler, Arizona, United States
Radiant Research, Inc
Scottsdale, Arizona, United States
ACR-Phase 1, LLC.
Anaheim, California, United States
Northern California Research
Sacramento, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Radiant Research, Inc
Santa Rosa, California, United States
Westlake Medical Research
Westlake Village, California, United States
Longmont Medical Research Network
Longmont, Colorado, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Clinical Study Center
Fort Myers, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Radiant Research, Inc
Atlanta, Georgia, United States
Advanced Clinical Research
Meridan, Idaho, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Radiant Research, Inc.
Overland Park, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Michigan Center for Research Corp, DBA Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
Radiant Research, Inc.
Edina, Minnesota, United States
Pioneer Clinical Research, LLC
Bellevue, Nebraska, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Physicians' Research, Inc.
Zanesville, Ohio, United States
Westover Heights Clinic
Portland, Oregon, United States
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, United States
Primary Physicians Research
Pittsburgh, Pennsylvania, United States
Radiant Research, Inc
Greer, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
J&S Studies, Inc.
College Station, Texas, United States
Radiant Research-Dallas North
Dallas, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Research Across America
Plano, Texas, United States
Intermountain Clinical Research
Draper, Utah, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
Countries
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Other Identifiers
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NB-001-004
Identifier Type: -
Identifier Source: org_study_id
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