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Completed

NCT Number: NCT01321359

A 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).

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Key information

Conditions

Recurrent Herpes Simplex Labialis DNA Virus Infections Herpes Labialis Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Radiant Research, Inc, Chandler, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vehicle versus NB-001

Drug

Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

NanoBio Corporation

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis

Acronym: SHaRCS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 23, 2011
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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