Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores

Herpes Labialis Clinical Trial

Official title: A Phase II, Randomized, Double-Blind, Parallel Group, Acyclovir-Controlled Study to Evaluate ZEP-3 Ointment for the Treatment of Cold Sores (Herpes Labialis).

Status Completed

Clinical Trial Summary

This is a phase II, prospective, randomized, double-blind, parallel group, acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes labialis), following five consecutive treatment days with five times daily topical administration.

Clinical Trial Description

The primary endpoint of this study are:

• "Time to healing" - Clinician-assessed duration in days of herpes labialis episode.

• Patient-assessed duration and intensity of pain by Visual Analog Scale (VAS).

• Safety and tolerability following five consecutive treatment days with five times daily topical administration.

The secondary endpoints of this study are:

• Proportion of subjects with non - ulcerative herpes lesion.

• Time for herpes labialis recurrences

Subject safety will be assessed following treatment by ZEP-3 ointment 1.0% or acyclovir cream 5% treatment, using measurements of the following variables:

• Physical examination,

• Vital Signs (HR, BP, Body temperature),

• Adverse events recording and

• Concomitant medications ;

Related Conditions & MeSH terms

• Herpes Labialis

• NCT number: NCT02483182
• Study type: Interventional
• Source: Shulov Innovate for Science Ltd. 2012
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Completion date: June 24, 2018