Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores
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|ClinicalTrials.gov Identifier: NCT02483182|
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Herpes Labialis||Drug: ZEP-3 ointment 1.0% Drug: Acyclovir cream 5%||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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).|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||June 24, 2018|
|Actual Study Completion Date :||June 24, 2018|
Experimental: ZEP-3 ointment 1.0%
Drug: ZEP-3 ointment 1.0%
Active Comparator: Acyclovir cream 5%
Drug: Acyclovir cream 5%
Other Name: Zovirax
- Clinician-assessed "Time to healing" [ Time Frame: Up to 14 days ]
- Time for Herpes labialis recurrences [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483182
|Dermatology out-patients clinic, Lev Hayasmin MC|
|Principal Investigator:||Shemer Avner, Prof., M.D.||Dermatology out-patients clinic, Lev Hayasmin - Medical center, Natanya, ISRAEL|