A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)
NCT ID: NCT01324466
Last Updated: 2013-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
847 participants
INTERVENTIONAL
2011-04-30
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
NCT01321359
Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
NCT00453401
NB-001 Treatment of Recurrent Herpes Labialis
NCT01695187
A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis
NCT03521479
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
NCT01971385
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vehicle
Vehicle
Vehicle
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Active
Active NB-001(0.3%)
NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Vehicle
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NanoBio Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radiant Research, Inc.
Birmingham, Alabama, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Radiant Research, Inc
Tucson, Arizona, United States
Providence Clinical Research
Burbank, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Staywell Research
Northridge, California, United States
Front Range Clinical Research
Wheat Ridge, Colorado, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Altus Research, Inc.
Lake Worth, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Radiant Research, Inc
Pinellas Park, Florida, United States
Radiant Research, Inc. Chicago
Chicago, Illinois, United States
DermResearch
Louisville, Kentucky, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States
Radiant Research, Inc.
St Louis, Missouri, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Axis Clinical Trials
New Hyde Park, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Radiant Research, Inc.
Akron, Ohio, United States
Radiant Research, Inc.
Cincinnati, Ohio, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Radiant Research, Inc.
Anderson, South Carolina, United States
DermResearch, Inc.
Austin, Texas, United States
Research Across America
Dallas, Texas, United States
Benchmark Research - San Angelo
San Angelo, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Utah Clinical Trials, LLC
Salt Lake City, Utah, United States
South Valley Dermatology
West Jordan, Utah, United States
IntegraTrials, LLC
Arlington, Virginia, United States
National Clinical Research
Richmond, Virginia, United States
Dermatology & Laser Center NW
Bellingham, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NB-001-005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.