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

  • STATUS
    Not Recruiting
  • participants needed
    210
  • sponsor
    Shulov Innovate for Science Ltd. 2012
Updated on 22 January 2021
herpes
acyclovir
acyclovir cream

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.

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

Details
Condition Herpes Labialis
Treatment ZEP-3 ointment 1.0%, Acyclovir cream 5%
Clinical Study IdentifierNCT02483182
SponsorShulov Innovate for Science Ltd. 2012
Last Modified on22 January 2021

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