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

Phase 3

Completed

Conditions: Recurrent Herpes Simplex Labialis

Interventions: Drug: Vehicle versus NB-001

Registration Number: NCT01321359

Lead Sponsor: NanoBio Corporation

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 907

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle versus NB-001	Vehicle
Active	Vehicle versus NB-001	Active NB-001(0.3%)

Primary Outcome Measures

Name	Time	Method
Time of Healing of the primary lesion complex	Days	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

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.	First Post-Treatment Visit	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.

Trial Locations

Locations (30): Westlake Medical Research
🇺🇸
Westlake Village, California, United States
Intermountain Clinical Research
🇺🇸
Draper, Utah, United States
Progressive Medical Research
🇺🇸
Port Orange, Florida, United States
Research Across America
🇺🇸
Plano, Texas, United States
MediSphere Medical Research Center, LLC
🇺🇸
Evansville, Indiana, United States
Radiant Research, Inc
🇺🇸
Greer, South Carolina, United States
Benchmark Research
🇺🇸
Fort Worth, Texas, United States
Avail Clinical Research, LLC
🇺🇸
DeLand, Florida, United States
Radiant Research, Inc.
🇺🇸
Edina, Minnesota, 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
Physicians' Research, Inc.
🇺🇸
Zanesville, Ohio, United States
Coastal Carolina Research Center
🇺🇸
Mount Pleasant, South Carolina, United States
Advanced Clinical Research
🇺🇸
Meridan, Idaho, United States
Regional Clinical Research, Inc.
🇺🇸
Endwell, New York, United States
Pioneer Clinical Research, LLC
🇺🇸
Bellevue, Nebraska, United States
ACR-Phase 1, LLC.
🇺🇸
Anaheim, California, United States
Northern California Research
🇺🇸
Sacramento, California, United States
Medical Center for Clinical Research
🇺🇸
San Diego, California, United States
Longmont Medical Research Network
🇺🇸
Longmont, Colorado, United States
Clinical Study Center
🇺🇸
Fort Myers, Florida, United States
AGA Clinical Trials
🇺🇸
Hialeah, Florida, United States
Orlando Clinical Research Center
🇺🇸
Orlando, Florida, United States
Central Kentucky Research Associates, Inc.
🇺🇸
Lexington, Kentucky, United States
Westover Heights Clinic
🇺🇸
Portland, Oregon, United States
Paddington Testing Co, Inc
🇺🇸
Philadelphia, Pennsylvania, United States
Primary Physicians Research
🇺🇸
Pittsburg, Pennsylvania, United States
Clinical Research Associates, Inc.
🇺🇸
Nashville, Tennessee, United States
Radiant Research-Dallas North
🇺🇸
Dallas, Texas, United States
New River Valley Research Institute
🇺🇸
Christiansburg, Virginia, United States