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

May 28, 2008 updated by: NanoBio Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Westlake Village, California, United States, 91361
        • Westlake Medical Research
    • Colorado
      • Wheatridge, Colorado, United States, 80033
        • Front Range Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • The Savin Center, PC
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida
      • Fort Myers, Florida, United States, 33916
        • Clinical Physiology Associates
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83704
        • Advanced Clinical Research, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • DermResearch, PLCC
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • MI Center for Skin Care Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-5239
        • Academic Dermatology Associates
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLM
    • Oregon
      • Portland, Oregon, United States, 97210
        • Westover Heights Clinic
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Lederach Family Medicine
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • Omega Medical Research
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Okatie Research Center, LLC
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch Inc.
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Bryan, Texas, United States, 77802
        • J&S Studies Inc.
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Dallas, Texas, United States, 75230
        • Dermatology Treatment & Research Center
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research, Inc
    • Utah
      • West Jordan, Utah, United States, 84088
        • South Valley Dermatology Center
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • New River Valley Research Institute
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time to healing as assessed by the subject.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NanoBio Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alicia Bucko, DO, Academic Dermatology Associates
  • Principal Investigator: Dennis Riff, MD, Advanced Clinical Research Institute
  • 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: 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: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB-001-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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