A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
SHaRCS
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
1 other identifier
interventional
907
1 country
35
Brief Summary
Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMay 23, 2013
May 1, 2013
9 months
March 22, 2011
May 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.
First Post-Treatment Visit
Study Arms (2)
Vehicle
PLACEBO COMPARATORVehicle
Active
ACTIVE COMPARATORActive NB-001(0.3%)
Interventions
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Radiant Research, Inc
Chandler, Arizona, 85225, United States
Radiant Research, Inc
Scottsdale, Arizona, 85251, United States
ACR-Phase 1, LLC.
Anaheim, California, 92801, United States
Northern California Research
Sacramento, California, 95821, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Radiant Research, Inc
Santa Rosa, California, 95405, United States
Westlake Medical Research
Westlake Village, California, 91361, United States
Longmont Medical Research Network
Longmont, Colorado, 80501, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Clinical Study Center
Fort Myers, Florida, 33916, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Radiant Research, Inc
Atlanta, Georgia, 30342, United States
Advanced Clinical Research
Meridan, Idaho, 83642, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Radiant Research, Inc.
Overland Park, Kansas, 66202, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Michigan Center for Research Corp, DBA Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038, United States
Radiant Research, Inc.
Edina, Minnesota, 55435, United States
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 68005, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Physicians' Research, Inc.
Zanesville, Ohio, 43701, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103, United States
Primary Physicians Research
Pittsburgh, Pennsylvania, 15241, United States
Radiant Research, Inc
Greer, South Carolina, 29651, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
J&S Studies, Inc.
College Station, Texas, 77845, United States
Radiant Research-Dallas North
Dallas, Texas, 75231, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Research Across America
Plano, Texas, 75093, United States
Intermountain Clinical Research
Draper, Utah, 84020, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
March 23, 2011
Study Start
April 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
May 23, 2013
Record last verified: 2013-05