Clinical trial NCT01321359: A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
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 Simplex Labialis
Lead sponsor: NanoBio Corporation
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 907
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: 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 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.

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