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

This study has been completed.
Sponsor:
Collaborators:
Norwich Clinical Research Associates Ltd.
Hill Top Research
Information provided by (Responsible Party):
Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier:
NCT01902303
First received: July 15, 2013
Last updated: March 27, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Oral Herpes Simplex
Drug: Matching Placebo
Drug: BTL-TML-HSV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Cold Sore Treatments on UV Induced Cold Sores

Resource links provided by NLM:


Further study details as provided by Beech Tree Labs, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 303
Study Start Date: July 2013
Study Completion Date: February 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Matching Placebo
Matching Placebo
Drug: Matching Placebo
Sublingual micro dosing of placebo for 7 days
Experimental: BTL-TML-HSV
Experimental Product
Drug: BTL-TML-HSV
Sublingual micro dosing of BTL-TML-HSV for 7 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902303

Locations
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States, 33714
United States, Ohio
Hill Top Research
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Beech Tree Labs, Inc.
Norwich Clinical Research Associates Ltd.
Hill Top Research
Investigators
Study Director: John McMichael, PhD President, Beech Tree Labs, Inc.
  More Information

Responsible Party: Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier: NCT01902303     History of Changes
Other Study ID Numbers: BTL - 2013-06-0161  HTR - 13-131178 
Study First Received: July 15, 2013
Results First Received: February 14, 2016
Last Updated: March 27, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Beech Tree Labs, Inc.:
Herpes Labialis
Herpes Simplex
Herpes
Ultra Violet (UV) Induced

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

ClinicalTrials.gov processed this record on May 24, 2016