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

NCT ID: NCT00453401

Last Updated: 2008-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Herpes Labialis

Keywords

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cold sore

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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NB-001

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NanoBio Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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NanoBio Corporation

Principal Investigators

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William Abramovits, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Treatment and Research Center

Jeffrey Adelglass, MD

Role: PRINCIPAL_INVESTIGATOR

Research Across America

Maurice Archuleta, MD

Role: PRINCIPAL_INVESTIGATOR

Front Range Clinical Research

Brian Bock, DO

Role: PRINCIPAL_INVESTIGATOR

Bock Clinical Research Incorporated

Alicia Bucko, DO

Role: PRINCIPAL_INVESTIGATOR

Academic Dermatology Associates

Teresa Coats, MD

Role: PRINCIPAL_INVESTIGATOR

Benchmark Research

Lisa Cohen, DO

Role: PRINCIPAL_INVESTIGATOR

Suncoast Clinical Research

John Eck, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Clinical Research Incorporated

Douglass Forsha, MD

Role: PRINCIPAL_INVESTIGATOR

South Valley Dermatology Center

David Fried, MD

Role: PRINCIPAL_INVESTIGATOR

Omega Medical Research

Helen Henry, MD

Role: PRINCIPAL_INVESTIGATOR

Westover Heights Clinic

Michael T Jarratt, MD

Role: PRINCIPAL_INVESTIGATOR

Derm Research Incorporated

Terry Jones, MD

Role: PRINCIPAL_INVESTIGATOR

J & S Studies

Steven Kaster, MD

Role: PRINCIPAL_INVESTIGATOR

Wenatchee Valley Medical Center

Leon Kircik, MD

Role: PRINCIPAL_INVESTIGATOR

DermResearch, PLCC

Ronica Kluge, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Physiology Associates

Elias Kolettis, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research of West Florida

Oswald Mikell, MD

Role: PRINCIPAL_INVESTIGATOR

Okati Research Center, LLC

Eugene Monroe, MD

Role: PRINCIPAL_INVESTIGATOR

Advance Healthcare

Edward Pornoy, MD

Role: PRINCIPAL_INVESTIGATOR

Westlake Medical Research

Harvey Resnick, MD

Role: PRINCIPAL_INVESTIGATOR

R/D Clinical Research Incorporated

Dennis Riff, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Clinical Research Institute

Mark A Ringold, MD

Role: PRINCIPAL_INVESTIGATOR

New River Valley Research Institute

Ronald Savin, MD

Role: PRINCIPAL_INVESTIGATOR

PC

Daniel Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

MI Center for Skin Care Research

Cynthia B Strout, MD

Role: PRINCIPAL_INVESTIGATOR

Coastal Carolina Research Center

Wayne Harper, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Research Associates, LLM

Timothy Howard, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Affiliated Reseach Center Incorporated

Locations

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Medical Affiliated Research Center, Inc.

Huntsville, Alabama, United States

Site Status

Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

Westlake Medical Research

Westlake Village, California, United States

Site Status

Front Range Clinical Research

Wheat Ridge, Colorado, United States

Site Status

The Savin Center, PC

New Haven, Connecticut, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

Clinical Physiology Associates

Fort Myers, Florida, United States

Site Status

Suncoast Clinical Research

New Port Richey, Florida, United States

Site Status

Advanced Clinical Research, Inc.

Boise, Idaho, United States

Site Status

DermResearch, PLCC

Louisville, Kentucky, United States

Site Status

MI Center for Skin Care Research

Clinton Township, Michigan, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

Wake Research Associates, LLM

Raleigh, North Carolina, United States

Site Status

Westover Heights Clinic

Portland, Oregon, United States

Site Status

Lederach Family Medicine

Harleysville, Pennsylvania, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

Site Status

Okatie Research Center, LLC

Beaufort, South Carolina, United States

Site Status

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Site Status

Benchmark Research

Austin, Texas, United States

Site Status

DermResearch Inc.

Austin, Texas, United States

Site Status

J&S Studies Inc.

Bryan, Texas, United States

Site Status

Dermatology Treatment & Research Center

Dallas, Texas, United States

Site Status

Research Across America

Dallas, Texas, United States

Site Status

R/D Clinical Research, Inc

Lake Jackson, Texas, United States

Site Status

South Valley Dermatology Center

West Jordan, Utah, United States

Site Status

New River Valley Research Institute

Christiansburg, Virginia, United States

Site Status

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Site Status

Advanced Healthcare

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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NB-001-003

Identifier Type: -

Identifier Source: org_study_id