Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
- Conditions
- Herpes Labialis
- Registration Number
- NCT00453401
- Lead Sponsor
- NanoBio Corporation
- Brief Summary
Purpose of this study is to determine the safety and efficacy of topical applications of NB-001 as compared to placebo for the treatment of recurrent herpes labialis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- 18 to 80 years of age of either gender
- Good general health
- History of recurrent herpes labialis with at least 3 episodes per year
- Pregnant and/or nursing female
- Lesions or irritation on or around the lips that would interfere with recognition of a herpes labialis attack
- Treatment with topical steroids, antivirals, or new topical products on or around the lips in the week prior to the onset of an attack
- Known allergies to topical creams, ointments or medications.
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to healing as assessed by the subject.
- Secondary Outcome Measures
Name Time Method Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.
Trial Locations
- Locations (28)
Okatie Research Center, LLC
🇺🇸Beaufort, South Carolina, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
The Savin Center, PC
🇺🇸New Haven, Connecticut, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Advanced Clinical Research, Inc.
🇺🇸Boise, Idaho, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Dermatology Treatment & Research Center
🇺🇸Dallas, Texas, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Research Across America
🇺🇸Dallas, Texas, United States
Wake Research Associates, LLM
🇺🇸Raleigh, North Carolina, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
DermResearch, PLCC
🇺🇸Louisville, Kentucky, United States
Lederach Family Medicine
🇺🇸Harleysville, Pennsylvania, United States
J&S Studies Inc.
🇺🇸Bryan, Texas, United States
R/D Clinical Research, Inc
🇺🇸Lake Jackson, Texas, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Benchmark Research
🇺🇸Austin, Texas, United States
South Valley Dermatology Center
🇺🇸West Jordan, Utah, United States
DermResearch Inc.
🇺🇸Austin, Texas, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Advanced Healthcare
🇺🇸Milwaukee, Wisconsin, United States
Clinical Physiology Associates
🇺🇸Fort Myers, Florida, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Front Range Clinical Research
🇺🇸Wheatridge, Colorado, United States
MI Center for Skin Care Research
🇺🇸Clinton Township, Michigan, United States