A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis

Recurrent Herpes Simplex Labialis Clinical Trial

— SHaRCS  

Official title:

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321359
• Other study ID #: NB-001-004
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2011
• Last updated: May 15, 2013
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: May 2013
• Source: NanoBio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).

Description:

This is a randomized, double-blind, two arm, parallel-group, vehicle-controlled, multi-center study of NB-001. The study is designed to demonstrate the safety and efficacy of NB-001 in subjects with RHL. Approximately 850 subjects who meet all eligibility criteria will be randomized in the study. Subjects will begin treatment as soon as they experience the onset of cold sore symptoms. Treatment will be applied 5 times daily, approximately 3-4 hours apart while awake. Treatment will continue until the investigator assesses the primary lesion complex as healed or a maximum of 4 days.

Clinic visits will occur on a daily basis until the investigator determines that the primary lesion complex has healed or a maximum of 15 clinic visits. At daily clinic visits, the investigator will make efficacy assessments of the primary lesion complex; safety and tolerability assessments of NB-001 following topical administration will also be assessed daily. Subjects will make daily assessments of therapy.

At the End of Study, the investigator will make a global assessment of therapy. The subject will make global assessments of therapy and social impact.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 907
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A Healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study.

• Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months;

• Have the majority of their cold sore recurrences proceeded by a well defined history of prodromal symptoms.

Exclusion Criteria:

• Subjects with severe chronic illness

• Received (within the last 6 months) or receiving chemotherapy;

• Significant skin disease on the face

• Previously received herpes vaccine;

• Active alcohol or drug abuse;

• Prior randomization into any NanoBio study;

• Known allergies to topical creams, ointments or other topical medications.

Study Design

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

Related Conditions & MeSH terms

• Herpes Labialis
• Herpes Simplex
• Recurrent Herpes Simplex Labialis

Intervention

Drug:
• Vehicle versus NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days

Locations

Country	Name	City	State
United States	ACR-Phase 1, LLC.	Anaheim	California
United States	Radiant Research, Inc	Atlanta	Georgia
United States	Pioneer Clinical Research, LLC	Bellevue	Nebraska
United States	Radiant Research, Inc	Chandler	Arizona
United States	New River Valley Research Institute	Christiansburg	Virginia
United States	Michigan Center for Research Corp, DBA Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	J&S Studies, Inc.	College Station	Texas
United States	Radiant Research-Dallas North	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Intermountain Clinical Research	Draper	Utah
United States	Radiant Research, Inc.	Edina	Minnesota
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Clinical Study Center	Fort Myers	Florida
United States	Benchmark Research	Fort Worth	Texas
United States	Radiant Research, Inc	Greer	South Carolina
United States	AGA Clinical Trials	Hialeah	Florida
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Advanced Clinical Research	Meridan	Idaho
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Radiant Research, Inc.	Overland Park	Kansas
United States	Paddington Testing Co, Inc	Philadelphia	Pennsylvania
United States	Primary Physicians Research	Pittsburg	Pennsylvania
United States	Research Across America	Plano	Texas
United States	Progressive Medical Research	Port Orange	Florida
United States	Westover Heights Clinic	Portland	Oregon
United States	Northern California Research	Sacramento	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Radiant Research, Inc	Santa Rosa	California
United States	Radiant Research, Inc	Scottsdale	Arizona
United States	Westlake Medical Research	Westlake Village	California
United States	Physicians' Research, Inc.	Zanesville	Ohio

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 of Healing of the primary lesion complex	Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. Time to healing is the time from application of the first dose to investigator assessed healing	Days	No
Secondary	Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.	Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.	First Post-Treatment Visit	No