Back to resultsSafety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
Primary Purpose
Herpes Labialis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NB-001
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis focused on measuring cold sore
Eligibility 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
Sites / Locations
- Medical Affiliated Research Center, Inc.
- Advanced Clinical Research Institute
- Westlake Medical Research
- Front Range Clinical Research
- The Savin Center, PC
- Clinical Research of West Florida
- Clinical Physiology Associates
- Suncoast Clinical Research
- Advanced Clinical Research, Inc.
- DermResearch, PLCC
- MI Center for Skin Care Research
- Academic Dermatology Associates
- Wake Research Associates, LLM
- Westover Heights Clinic
- Lederach Family Medicine
- Omega Medical Research
- Okatie Research Center, LLC
- Coastal Carolina Research Center
- Benchmark Research
- DermResearch Inc.
- J&S Studies Inc.
- Dermatology Treatment & Research Center
- Research Across America
- R/D Clinical Research, Inc
- South Valley Dermatology Center
- New River Valley Research Institute
- Wenatchee Valley Medical Center
- Advanced Healthcare
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00453401
Brief Title
Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
Official Title
The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NanoBio Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
Keywords
cold sore
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NB-001
Primary Outcome Measure Information:
Title
Time to healing as assessed by the subject.
Secondary Outcome Measure Information:
Title
Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Abramovits, MD
Organizational Affiliation
Dermatology Treatment and Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Adelglass, MD
Organizational Affiliation
Research Across America
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maurice Archuleta, MD
Organizational Affiliation
Front Range Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Bock, DO
Organizational Affiliation
Bock Clinical Research Incorporated
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alicia Bucko, DO
Organizational Affiliation
Academic Dermatology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teresa Coats, MD
Organizational Affiliation
Benchmark Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Cohen, DO
Organizational Affiliation
Suncoast Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Eck, MD
Organizational Affiliation
Advanced Clinical Research Incorporated
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglass Forsha, MD
Organizational Affiliation
South Valley Dermatology Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Fried, MD
Organizational Affiliation
Omega Medical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen Henry, MD
Organizational Affiliation
Westover Heights Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael T Jarratt, MD
Organizational Affiliation
Derm Research Incorporated
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terry Jones, MD
Organizational Affiliation
J & S Studies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Kaster, MD
Organizational Affiliation
Wenatchee Valley Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leon Kircik, MD
Organizational Affiliation
DermResearch, PLCC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronica Kluge, MD
Organizational Affiliation
Clinical Physiology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elias Kolettis, MD
Organizational Affiliation
Clinical Research of West Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oswald Mikell, MD
Organizational Affiliation
Okati Research Center, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene Monroe, MD
Organizational Affiliation
Advance Healthcare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Pornoy, MD
Organizational Affiliation
Westlake Medical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harvey Resnick, MD
Organizational Affiliation
R/D Clinical Research Incorporated
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis Riff, MD
Organizational Affiliation
Advanced Clinical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark A Ringold, MD
Organizational Affiliation
New River Valley Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald Savin, MD
Organizational Affiliation
PC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Stewart, MD
Organizational Affiliation
MI Center for Skin Care Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia B Strout, MD
Organizational Affiliation
Coastal Carolina Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wayne Harper, MD
Organizational Affiliation
Wake Research Associates, LLM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Howard, MD
Organizational Affiliation
Medical Affiliated Reseach Center Incorporated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Front Range Clinical Research
City
Wheatridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
The Savin Center, PC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Physiology Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Advanced Clinical Research, Inc.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
DermResearch, PLCC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
MI Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106-5239
Country
United States
Facility Name
Wake Research Associates, LLM
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lederach Family Medicine
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Okatie Research Center, LLC
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
DermResearch Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Dermatology Treatment & Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
R/D Clinical Research, Inc
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
South Valley Dermatology Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Advanced Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
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