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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

March 26, 2007
May 28, 2008
February 2007
December 2007   (final data collection date for primary outcome measure)
Time to healing as assessed by the subject.
Same as current
Complete list of historical versions of study NCT00453401 on ClinicalTrials.gov Archive Site
Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.
Same as current
Not Provided
Not Provided
 
Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Herpes Labialis
Drug: NB-001
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
December 2007
December 2007   (final data collection date for primary outcome measure)

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

Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00453401
NB-001-003
No
Mary Flack, MD, NanoBio Corporation
NanoBio Corporation
Not Provided
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
NanoBio Corporation
May 2008

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