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Completed

NCT Number: NCT01902303

Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores

The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.

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Key information

Conditions

Oral Herpes Simplex 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 Stomatitis Stomatitis, Herpetic Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hill Top Research, St. Petersburg, Florida, United States

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About this study

This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design

The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.

The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.

The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical history of recurrent cold sores averaging 2 or more episodes per year
  • UV exposure is known to cause a cold sore outbreak

Exclusion criteria

  • History of abnormal reactions to sunlight
  • Used antiviral therapy directly prior to entering study
  • Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.

Treatment and study plan

Matching Placebo

Drug

Sublingual micro dosing of placebo for 7 days

BTL-TML-HSV

Drug

Sublingual micro dosing of BTL-TML-HSV for 7 days

Primary outcomes

  1. Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator

    Time frame: Day 0- Day 7

    The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.

Secondary outcomes

  1. Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant

    Time frame: 0 -7 days

    The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.

Sponsors and collaborators

Lead sponsor

Beech Tree Labs, Inc.

Industry

Collaborators

  • Hill Top Research
  • Norwich Clinical Research Associates Ltd.

Registry information

Official study title

Evaluation of Cold Sore Treatments on UV Induced Cold Sores

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 18, 2013
Registry last updated
Apr 28, 2016

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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