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

Herpes Labialis Clinical Trial

Official title:

The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453401
• Other study ID #: NB-001-003
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2007
• Last updated: May 28, 2008
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: NanoBio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Labialis

Intervention

Drug:
• NB-001

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Benchmark Research	Austin	Texas
United States	DermResearch Inc.	Austin	Texas
United States	Okatie Research Center, LLC	Beaufort	South Carolina
United States	Advanced Clinical Research, Inc.	Boise	Idaho
United States	J&S Studies Inc.	Bryan	Texas
United States	New River Valley Research Institute	Christiansburg	Virginia
United States	Clinical Research of West Florida	Clearwater	Florida
United States	MI Center for Skin Care Research	Clinton Township	Michigan
United States	Dermatology Treatment & Research Center	Dallas	Texas
United States	Research Across America	Dallas	Texas
United States	Clinical Physiology Associates	Fort Myers	Florida
United States	Lederach Family Medicine	Harleysville	Pennsylvania
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	R/D Clinical Research, Inc	Lake Jackson	Texas
United States	DermResearch, PLCC	Louisville	Kentucky
United States	Advanced Healthcare	Milwaukee	Wisconsin
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	The Savin Center, PC	New Haven	Connecticut
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Westover Heights Clinic	Portland	Oregon
United States	Wake Research Associates, LLM	Raleigh	North Carolina
United States	Omega Medical Research	Warwick	Rhode Island
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	South Valley Dermatology Center	West Jordan	Utah
United States	Westlake Medical Research	Westlake Village	California
United States	Front Range Clinical Research	Wheatridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
NanoBio Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to healing as assessed by the subject.
Secondary	Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.