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

Oral Herpes Simplex Clinical Trial

Official title:

Evaluation of Cold Sore Treatments on UV Induced Cold Sores

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902303
• Other study ID #: BTL - 2013-06-0161
• Secondary ID: HTR - 13-131178
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2013
• Last updated: February 14, 2016
• Start date: July 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: Beech Tree Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex
• Oral Herpes Simplex

Intervention

Drug:
• Matching Placebo
Sublingual micro dosing of placebo for 7 days
• BTL-TML-HSV
Sublingual micro dosing of BTL-TML-HSV for 7 days

Locations

Country	Name	City	State
United States	Hill Top Research	Cincinnati	Ohio
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Hill Top Research	St. Petersburg	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Beech Tree Labs, Inc.	Hill Top Research, Norwich Clinical Research Associates Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Block the Symptomatic Sequence of a Lesion of Oral Herpes Simplex Outbreak	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.	Day 7	No
Secondary	Aborted Lesions as Assessed by the Participants	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 particpant. 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.	7 days	No