A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)
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
847
1 country
35
Brief Summary
The purpose of this study is to 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 29, 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
Median time to healing (day 1 until up to 4 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 (after maximum 15 clinical visits)
Study Arms (2)
Vehicle
PLACEBO COMPARATORVehicle
Active
ACTIVE COMPARATORActive NB-001(0.3%)
Interventions
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 preceded 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.
Birmingham, Alabama, 35209, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
Radiant Research, Inc
Tucson, Arizona, 85710, United States
Providence Clinical Research
Burbank, California, 91505, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Axis Clinical Trials
Los Angeles, California, 90057, United States
Staywell Research
Northridge, California, 91325, United States
Front Range Clinical Research
Wheat Ridge, Colorado, 80033, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Altus Research, Inc.
Lake Worth, Florida, 33461, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Radiant Research, Inc
Pinellas Park, Florida, 33781, United States
Radiant Research, Inc. Chicago
Chicago, Illinois, 60654, United States
DermResearch
Louisville, Kentucky, 40217, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, 42431, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114, United States
Radiant Research, Inc.
St Louis, Missouri, 63141, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Axis Clinical Trials
New Hyde Park, New York, 11040, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Radiant Research, Inc.
Akron, Ohio, 44311, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45249, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, 15017, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Research Across America
Dallas, Texas, 75234, United States
Benchmark Research - San Angelo
San Angelo, Texas, 76904, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
Utah Clinical Trials, LLC
Salt Lake City, Utah, 84107, United States
South Valley Dermatology
West Jordan, Utah, 84088, United States
IntegraTrials, LLC
Arlington, Virginia, 22205, United States
National Clinical Research
Richmond, Virginia, 23294, United States
Dermatology & Laser Center NW
Bellingham, Washington, 98225, United States
MeSH Terms
Conditions
Interventions
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 29, 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