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Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis

Phase 2
Completed
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
Inclusion Criteria
  • 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 Criteria
  • 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
NameTimeMethod
Time to healing as assessed by the subject.
Secondary Outcome Measures
NameTimeMethod
Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.

Trial Locations

Locations (28)

Medical Affiliated Research Center, Inc.

🇺🇸

Huntsville, Alabama, United States

Advanced Clinical Research Institute

🇺🇸

Anaheim, California, United States

Westlake Medical Research

🇺🇸

Westlake Village, California, United States

Front Range Clinical Research

🇺🇸

Wheatridge, Colorado, United States

The Savin Center, PC

🇺🇸

New Haven, Connecticut, United States

Clinical Research of West Florida

🇺🇸

Clearwater, Florida, United States

Clinical Physiology Associates

🇺🇸

Fort Myers, Florida, United States

Suncoast Clinical Research

🇺🇸

New Port Richey, Florida, United States

Advanced Clinical Research, Inc.

🇺🇸

Boise, Idaho, United States

DermResearch, PLCC

🇺🇸

Louisville, Kentucky, United States

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Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States

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