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

This study has been completed.
Sponsor:
Information provided by:
NanoBio Corporation
ClinicalTrials.gov Identifier:
NCT00453401
First received: March 26, 2007
Last updated: May 28, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Herpes Labialis
Drug: NB-001
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis

Resource links provided by NLM:


Further study details as provided by NanoBio Corporation:

Primary Outcome Measures:
  • Time to healing as assessed by the subject.

Secondary Outcome Measures:
  • Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.

Estimated Enrollment: 1000
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453401

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

No publications provided

Responsible Party: Mary Flack, MD, NanoBio Corporation
ClinicalTrials.gov Identifier: NCT00453401     History of Changes
Other Study ID Numbers: NB-001-003
Study First Received: March 26, 2007
Last Updated: May 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NanoBio Corporation:
cold sore

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on August 20, 2014