Status:
COMPLETED
Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
Lead Sponsor:
NanoBio Corporation
Conditions:
Herpes Labialis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 18 to 80 years of age of either gender
- Good general health
- History of recurrent herpes labialis with at least 3 episodes per year
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00453401
Start Date
February 1 2007
End Date
December 1 2007
Last Update
May 30 2008
Active Locations (28)
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1
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
2
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
3
Westlake Medical Research
Westlake Village, California, United States, 91361
4
Front Range Clinical Research
Wheat Ridge, Colorado, United States, 80033