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

The purpose of this study is to demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).

Study Overview

• Status: Completed
• Conditions: Recurrent Herpes Labialis
• Intervention / Treatment: Drug: Vehicle; Drug: 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): 847
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Radiant Research, Inc.
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies, LLC
    • Tucson, Arizona, United States, 85710
      • Radiant Research, Inc
  • California
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Los Angeles, California, United States, 90057
      • Axis Clinical Trials
    • Northridge, California, United States, 91325
      • Staywell Research
  • Colorado
    • Wheatridge, Colorado, United States, 80033
      • Front Range Clinical Research
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Lake Worth, Florida, United States, 33461
      • Altus Research, Inc.
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research, Inc
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Radiant Research, Inc. Chicago
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch
    • Madisonville, Kentucky, United States, 42431
      • Commonwealth BioMedical Research
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research, P.C.
    • St. Louis, Missouri, United States, 63141
      • Radiant Research, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
  • New York
    • New Hyde Park, New York, United States, 11040
      • Axis Clinical Trials
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc.
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc.
  • Pennsylvania
    • Bridgeville, Pennsylvania, United States, 15017
      • Paramount Clinical Research
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Dallas, Texas, United States, 75234
      • Research Across America
    • San Angelo, Texas, United States, 76904
      • Benchmark Research - San Angelo
    • San Antonio, Texas, United States, 78229
      • Radiant Research, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Utah Clinical Trials, LLC
    • West Jordan, Utah, United States, 84088
      • South Valley Dermatology
  • Virginia
    • Arlington, Virginia, United States, 22205
      • IntegraTrials, LLC
    • Richmond, Virginia, United States, 23294
      • National Clinical Research
  • Washington
    • Bellingham, Washington, United States, 98225
      • Dermatology & Laser Center NW

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 preceded 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
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle	Drug: Vehicle; Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
ACTIVE_COMPARATOR: Active; Active NB-001(0.3%)	Drug: 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	Median time to healing (day 1 until up to 4 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 (after maximum 15 clinical visits)

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 28, 2011
• First Posted (ESTIMATE): March 29, 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-001-005