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

Recurrent Herpes 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: NCT01324466
• Other study ID #: NB-001-005
• 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

The purpose of this study is to 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: 847
• 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 preceded 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
• Recurrent Herpes Labialis

Intervention

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

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Akron	Ohio
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	IntegraTrials, LLC	Arlington	Virginia
United States	DermResearch, Inc.	Austin	Texas
United States	Dermatology & Laser Center NW	Bellingham	Washington
United States	Radiant Research, Inc.	Birmingham	Alabama
United States	Paramount Clinical Research	Bridgeville	Pennsylvania
United States	Providence Clinical Research	Burbank	California
United States	Radiant Research, Inc. Chicago	Chicago	Illinois
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Research Across America	Dallas	Texas
United States	The Center for Pharmaceutical Research, P.C.	Kansas City	Missouri
United States	Altus Research, Inc.	Lake Worth	Florida
United States	Axis Clinical Trials	Los Angeles	California
United States	Axis Clinical Trials	Los Angeles	California
United States	DermResearch	Louisville	Kentucky
United States	Commonwealth Biomedical Research	Madisonville	Kentucky
United States	Axis Clinical Trials	New Hyde Park	New York
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Staywell Research	Northridge	California
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Elite Clinical Studies, LLC	Phoenix	Arizona
United States	Radiant Research, Inc	Pinellas Park	Florida
United States	National Clinical Research	Richmond	Virginia
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Utah Clinical Trials, LLC	Salt Lake City	Utah
United States	Benchmark Research - San Angelo	San Angelo	Texas
United States	Radiant Research, Inc.	San Antonio	Texas
United States	Radiant Research, Inc.	St. Louis	Missouri
United States	Radiant Research, Inc	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	South Valley Dermatology	West Jordan	Utah
United States	Front Range Clinical Research	Wheatridge	Colorado
United States	Upstate Clinical Research Associates	Williamsville	New York

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	Median time to healing (day 1 until up to 4 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 (after maximum 15 clinical visits)	No