NCT02483182

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Shulov Innovate for Science Ltd. 2012 · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	ZEP-3 ointment 1.0%
DRUG	Acyclovir cream 5%

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-06-24
• Completion: 2018-06-24
• First posted: 2015-06-26
• Last updated: 2019-05-30

Locations

1 site across 1 country: Israel