Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00453401
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : May 30, 2008
Sponsor:
Information provided by:
NanoBio Corporation

Tracking Information
First Submitted Date  ICMJE March 26, 2007
First Posted Date  ICMJE March 28, 2007
Last Update Posted Date May 30, 2008
Study Start Date  ICMJE February 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2007)
Time to healing as assessed by the subject.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2007)
Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
Official Title  ICMJE The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Herpes Labialis
Intervention  ICMJE Drug: NB-001
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 27, 2007)
1000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00453401
Other Study ID Numbers  ICMJE NB-001-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary Flack, MD, NanoBio Corporation
Study Sponsor  ICMJE NanoBio Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account NanoBio Corporation
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP