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

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

Study Overview

• Status: Completed
• Conditions: Recurrent Herpes Simplex Labialis
• Intervention / Treatment: Drug: Vehicle versus NB-001

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
• Enrollment (Actual): 907
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: NanoBio Corporation

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): May 23, 2013
• Last Update Submitted That Met QC Criteria: May 15, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Virus Diseases; Infections; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Lip Diseases; Recurrence; Herpes Simplex; Herpes Labialis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Adenylyl Cyclase Inhibitors; 5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol
• Other Study ID Numbers: NB-001-004