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

May 28, 2008 updated by: NanoBio Corporation

The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Westlake Village, California, United States, 91361
        • Westlake Medical Research
    • Colorado
      • Wheatridge, Colorado, United States, 80033
        • Front Range Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • The Savin Center, PC
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida
      • Fort Myers, Florida, United States, 33916
        • Clinical Physiology Associates
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83704
        • Advanced Clinical Research, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • DermResearch, PLCC
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • MI Center for Skin Care Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-5239
        • Academic Dermatology Associates
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLM
    • Oregon
      • Portland, Oregon, United States, 97210
        • Westover Heights Clinic
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Lederach Family Medicine
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • Omega Medical Research
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Okatie Research Center, LLC
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch Inc.
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Bryan, Texas, United States, 77802
        • J&S Studies Inc.
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Dallas, Texas, United States, 75230
        • Dermatology Treatment & Research Center
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research, Inc
    • Utah
      • West Jordan, Utah, United States, 84088
        • South Valley Dermatology Center
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • New River Valley Research Institute
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to healing as assessed by the subject.

Secondary Outcome Measures

Outcome Measure
Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NanoBio Corporation

Investigators

  • Principal Investigator: Alicia Bucko, DO, Academic Dermatology Associates
  • Principal Investigator: Dennis Riff, MD, Advanced Clinical Research Institute
  • Principal Investigator: William Abramovits, MD, Dermatology Treatment and Research Center
  • Principal Investigator: Jeffrey Adelglass, MD, Research Across America
  • Principal Investigator: Maurice Archuleta, MD, Front Range Clinical Research
  • Principal Investigator: Brian Bock, DO, Bock Clinical Research Incorporated
  • Principal Investigator: Teresa Coats, MD, Benchmark Research
  • Principal Investigator: Lisa Cohen, DO, Suncoast Clinical Research
  • Principal Investigator: John Eck, MD, Advanced Clinical Research Incorporated
  • Principal Investigator: Douglass Forsha, MD, South Valley Dermatology Center
  • Principal Investigator: David Fried, MD, Omega Medical Research
  • Principal Investigator: Helen Henry, MD, Westover Heights Clinic
  • Principal Investigator: Michael T Jarratt, MD, Derm Research Incorporated
  • Principal Investigator: Terry Jones, MD, J & S Studies
  • Principal Investigator: Steven Kaster, MD, Wenatchee Valley Medical Center
  • Principal Investigator: Leon Kircik, MD, DermResearch, PLCC
  • Principal Investigator: Ronica Kluge, MD, Clinical Physiology Associates
  • Principal Investigator: Elias Kolettis, MD, Clinical Research of West Florida
  • Principal Investigator: Oswald Mikell, MD, Okati Research Center, LLC
  • Principal Investigator: Eugene Monroe, MD, Advance Healthcare
  • Principal Investigator: Edward Pornoy, MD, Westlake Medical Research
  • Principal Investigator: Harvey Resnick, MD, R/D Clinical Research Incorporated
  • Principal Investigator: Mark A Ringold, MD, New River Valley Research Institute
  • Principal Investigator: Ronald Savin, MD, PC
  • Principal Investigator: Daniel Stewart, MD, MI Center for Skin Care Research
  • Principal Investigator: Cynthia B Strout, MD, Coastal Carolina Research Center
  • Principal Investigator: Wayne Harper, MD, Wake Research Associates, LLM
  • Principal Investigator: Timothy Howard, MD, Medical Affiliated Reseach Center Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (Estimate)

March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

May 30, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NB-001-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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