Clinical trial NCT01324466: A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)
Official title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Herpes Labialis
Lead sponsor: NanoBio Corporation
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 847
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time of Healing of the primary lesion complex
timeFrame: Median time to healing (day 1 until up to 4 days)
Secondary outcomes:
measure: Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.
timeFrame: First Post-Treatment Visit (after maximum 15 clinical visits)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Northridge
country: United States
facility: Staywell Research
state: California
city: Wheatridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc
state: Florida
city: Chicago
country: United States
facility: Radiant Research, Inc. Chicago
state: Illinois
city: Louisville
country: United States
facility: DermResearch
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research
state: Kentucky
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, P.C.
state: Missouri
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: New Hyde Park
country: United States
facility: Axis Clinical Trials
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Bridgeville
country: United States
facility: Paramount Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research - San Angelo
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Utah Clinical Trials, LLC
state: Utah
city: West Jordan
country: United States
facility: South Valley Dermatology
state: Utah
city: Arlington
country: United States
facility: IntegraTrials, LLC
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research
state: Virginia
city: Bellingham
country: United States
facility: Dermatology & Laser Center NW
state: Washington
Study officials:
References: