We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01902303
First Posted: July 18, 2013
Last Update Posted: April 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Norwich Clinical Research Associates Ltd.
Hill Top Research
Information provided by (Responsible Party):
Beech Tree Labs, Inc.
July 15, 2013
July 18, 2013
February 14, 2016
March 14, 2016
April 28, 2016
July 2013
September 2014   (Final data collection date for primary outcome measure)
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.
Block the Symptomatic Sequence of a Lesion of Oral Herpes Simplex Outbreak [ Time Frame: 14 days ]
Visual examination of cold sores by trained evaluator and subject self assessment after exposure to UV.
Complete list of historical versions of study NCT01902303 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores
Evaluation of Cold Sore Treatments on 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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Oral Herpes Simplex
  • Drug: Matching Placebo
    Sublingual micro dosing of placebo for 7 days
  • Drug: BTL-TML-HSV
    Sublingual micro dosing of BTL-TML-HSV for 7 days
  • Placebo Comparator: Matching Placebo
    Matching Placebo
    Intervention: Drug: Matching Placebo
  • Experimental: BTL-TML-HSV
    Experimental Product
    Intervention: Drug: BTL-TML-HSV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
February 2015
September 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT01902303
BTL - 2013-06-0161
HTR - 13-131178 ( Other Identifier: Hill Top Research )
No
Not Provided
Plan to Share IPD: No
Beech Tree Labs, Inc.
Beech Tree Labs, Inc.
  • Norwich Clinical Research Associates Ltd.
  • Hill Top Research
Study Director: John McMichael, PhD President, Beech Tree Labs, Inc.
Beech Tree Labs, Inc.
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP