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

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

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

Keywords provided by NanoBio Corporation:

cold sore

Study placed in the following topic categories:

Mouth Diseases

Virus Diseases

Herpes Simplex

Skin Diseases, Infectious

Skin Diseases

DNA Virus Infections

Stomatognathic Diseases

Recurrence

Herpesviridae Infections

Herpes Labialis

Additional relevant MeSH terms:

Skin Diseases, Viral

Lip Diseases

ClinicalTrials.gov processed this record on October 20, 2008

Sponsored by:	NanoBio Corporation
Information provided by:	NanoBio Corporation
ClinicalTrials.gov Identifier:	NCT00453401