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).
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.
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
;
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