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

  Show 28 Study Locations
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 September 18, 2014