NCT00453401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 30, 2008

Status Verified

May 1, 2008

Enrollment Period

10 months

First QC Date

March 26, 2007

Last Update Submit

May 28, 2008

Conditions

Herpes Labialis

Keywords

cold sore

Outcome Measures

Primary Outcomes (1)

  • Time to healing as assessed by the subject.

Secondary Outcomes (1)

  • Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.

Interventions

NB-001DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years of age of either gender
  • Good general health
  • History of recurrent herpes labialis with at least 3 episodes per year

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Westlake Medical Research

Westlake Village, California, 91361, United States

Location

Front Range Clinical Research

Wheat Ridge, Colorado, 80033, United States

Location

The Savin Center, PC

New Haven, Connecticut, 06511, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33916, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

Advanced Clinical Research, Inc.

Boise, Idaho, 83704, United States

Location

DermResearch, PLCC

Louisville, Kentucky, 40217, United States

Location

MI Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106-5239, United States

Location

Wake Research Associates, LLM

Raleigh, North Carolina, 27612, United States

Location

Westover Heights Clinic

Portland, Oregon, 97210, United States

Location

Lederach Family Medicine

Harleysville, Pennsylvania, 19438, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02888, United States

Location

Okatie Research Center, LLC

Beaufort, South Carolina, 29902, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

J&S Studies Inc.

Bryan, Texas, 77802, United States

Location

Dermatology Treatment & Research Center

Dallas, Texas, 75230, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

R/D Clinical Research, Inc

Lake Jackson, Texas, 77566, United States

Location

South Valley Dermatology Center

West Jordan, Utah, 84088, United States

Location

New River Valley Research Institute

Christiansburg, Virginia, 24073, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801, United States

Location

Advanced Healthcare

Milwaukee, Wisconsin, 53209, United States

Location

MeSH Terms

Conditions

Herpes Labialis

Interventions

5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol

Condition Hierarchy (Ancestors)

Herpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralLip DiseasesMouth DiseasesStomatognathic DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 28, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 30, 2008

Record last verified: 2008-05

Locations

US(28)