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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321359
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : May 23, 2013
Information provided by (Responsible Party):
NanoBio Corporation

Brief Summary:
Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).

Condition or disease Intervention/treatment Phase
Recurrent Herpes Simplex Labialis Drug: Vehicle versus NB-001 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 907 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
Study Start Date : April 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Vehicle
Drug: Vehicle versus NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
Active Comparator: Active
Active NB-001(0.3%)
Drug: Vehicle versus NB-001
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days

Primary Outcome Measures :
  1. Time of Healing of the primary lesion complex [ Time Frame: 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 :
  1. Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321359

  Hide Study Locations
United States, Arizona
Radiant Research, Inc
Chandler, Arizona, United States, 85225
Radiant Research, Inc
Scottsdale, Arizona, United States, 85251
United States, California
ACR-Phase 1, LLC.
Anaheim, California, United States, 92801
Northern California Research
Sacramento, California, United States, 95821
Medical Center for Clinical Research
San Diego, California, United States, 92108
Radiant Research, Inc
Santa Rosa, California, United States, 95405
Westlake Medical Research
Westlake Village, California, United States, 91361
United States, Colorado
Longmont Medical Research Network
Longmont, Colorado, United States, 80501
United States, Florida
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Clinical Study Center
Fort Myers, Florida, United States, 33916
AGA Clinical Trials
Hialeah, Florida, United States, 33012
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Progressive Medical Research
Port Orange, Florida, United States, 32127
United States, Georgia
Radiant Research, Inc
Atlanta, Georgia, United States, 30342
United States, Idaho
Advanced Clinical Research
Meridan, Idaho, United States, 83642
United States, Indiana
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Kansas
Radiant Research, Inc.
Overland Park, Kansas, United States, 66202
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Michigan
Michigan Center for Research Corp, DBA Michigan Center for Skin Care Research
Clinton Township, Michigan, United States, 48038
United States, Minnesota
Radiant Research, Inc.
Edina, Minnesota, United States, 55435
United States, Nebraska
Pioneer Clinical Research, LLC
Bellevue, Nebraska, United States, 68005
United States, New York
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
United States, Ohio
Physicians' Research, Inc.
Zanesville, Ohio, United States, 43701
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, United States, 19103
Primary Physicians Research
Pittsburg, Pennsylvania, United States, 15241
United States, South Carolina
Radiant Research, Inc
Greer, South Carolina, United States, 29651
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
J&S Studies, Inc.
College Station, Texas, United States, 77845
Radiant Research-Dallas North
Dallas, Texas, United States, 75231
Benchmark Research
Fort Worth, Texas, United States, 76135
Research Across America
Plano, Texas, United States, 75093
United States, Utah
Intermountain Clinical Research
Draper, Utah, United States, 84020
United States, Virginia
New River Valley Research Institute
Christiansburg, Virginia, United States, 24073
Sponsors and Collaborators
NanoBio Corporation

Responsible Party: NanoBio Corporation Identifier: NCT01321359     History of Changes
Other Study ID Numbers: NB-001-004
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Herpes Simplex
Herpes Labialis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
5- ((2- (6- Amino- 9H- purin- 9- yl) ethyl) amino) - 1- pentanol
Adenylyl Cyclase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action