Clinical trial NCT00453401: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Labialis
Keywords: cold sore
Lead sponsor: NanoBio Corporation
Sponsor class: INDUSTRY
First posted: 2007-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to healing as assessed by the subject.
Secondary outcomes:
measure: Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Wheatridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Boise
country: United States
facility: Advanced Clinical Research, Inc.
state: Idaho
city: Louisville
country: United States
facility: DermResearch, PLCC
state: Kentucky
city: Clinton Township
country: United States
facility: MI Center for Skin Care Research
state: Michigan
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Raleigh
country: United States
facility: Wake Research Associates, LLM
state: North Carolina
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Harleysville
country: United States
facility: Lederach Family Medicine
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Beaufort
country: United States
facility: Okatie Research Center, LLC
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
city: Bryan
country: United States
facility: J&S Studies Inc.
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc
state: Texas
city: West Jordan
country: United States
facility: South Valley Dermatology Center
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare
state: Wisconsin
Study officials:
affiliation: Dermatology Treatment and Research Center
name: William Abramovits, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Across America
name: Jeffrey Adelglass, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Front Range Clinical Research
name: Maurice Archuleta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bock Clinical Research Incorporated
name: Brian Bock, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Dermatology Associates
name: Alicia Bucko, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Benchmark Research
name: Teresa Coats, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Suncoast Clinical Research
name: Lisa Cohen, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Clinical Research Incorporated
name: John Eck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Valley Dermatology Center
name: Douglass Forsha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Omega Medical Research
name: David Fried, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Westover Heights Clinic
name: Helen Henry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derm Research Incorporated
name: Michael T Jarratt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: J & S Studies
name: Terry Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wenatchee Valley Medical Center
name: Steven Kaster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DermResearch, PLCC
name: Leon Kircik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Physiology Associates
name: Ronica Kluge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research of West Florida
name: Elias Kolettis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Okati Research Center, LLC
name: Oswald Mikell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advance Healthcare
name: Eugene Monroe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Westlake Medical Research
name: Edward Pornoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: R/D Clinical Research Incorporated
name: Harvey Resnick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Clinical Research Institute
name: Dennis Riff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New River Valley Research Institute
name: Mark A Ringold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PC
name: Ronald Savin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MI Center for Skin Care Research
name: Daniel Stewart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Coastal Carolina Research Center
name: Cynthia B Strout, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Research Associates, LLM
name: Wayne Harper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Affiliated Reseach Center Incorporated
name: Timothy Howard, MD
role: PRINCIPAL_INVESTIGATOR
References: