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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NanoBio Corporation
ClinicalTrials.gov Identifier:
NCT01321359
First received: March 22, 2011
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Recurrent Herpes Simplex Labialis
 Drug: Vehicle versus NB-001
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NanoBio Corporation:

Primary Outcome Measures:
  • Time of Healing of the primary lesion complex [ Time Frame: Days ] [ Designated as safety issue: No ]
    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:
  • Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. [ Time Frame: First Post-Treatment Visit ] [ Designated as safety issue: No ]
    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.


Enrollment: 907
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321359

  Show 35 Study Locations
Sponsors and Collaborators
NanoBio Corporation
  More Information

No publications provided

Responsible Party: NanoBio Corporation
ClinicalTrials.gov Identifier: NCT01321359     History of Changes
Other Study ID Numbers: NB-001-004
Study First Received: March 22, 2011
Last Updated: January 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013