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

Phase 2

Completed

• Conditions: Oral Herpes Simplex
• Interventions: Drug: Matching Placebo; Drug: BTL-TML-HSV

• Registration Number: NCT01902303
• Lead Sponsor: Beech Tree Labs, Inc.

Brief 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.

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-18
• Primary Completion: 2014-09
• Study Completion: 2015-02
• Results First Submitted: 2016-02-14
• Results First Submitted QC: 2016-02-14
• Status Verified: 2016-03
• Results First Posted: 2016-03-14
• Last Update Submitted: 2016-03-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching Placebo	Matching Placebo	Matching Placebo
BTL-TML-HSV	BTL-TML-HSV	Experimental Product

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (2)

Coastal Carolina Research Center; 🇺🇸 Mt. Pleasant, South Carolina, United States

Hill Top Research; 🇺🇸 Cincinnati, Ohio, United States