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

Beech Tree Labs

Status and phase

Completed

Phase 2

Conditions

Oral Herpes Simplex

Treatments

Drug: Matching Placebo

Drug: BTL-TML-HSV

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01902303

HTR - 13-131178 (Other Identifier)

BTL - 2013-06-0161

Details and patient eligibility

About

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.

Full 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.

Enrollment

303 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.