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

NCT02483182 Phase 2 COMPLETED

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.

Details

Lead sponsor	Shulov Innovate for Science Ltd. 2012
Phase	Phase 2
Status	COMPLETED
Enrolment	210
Start date	2015-09
Completion	2018-06-24

Conditions

• Herpes Labialis

Interventions

• ZEP-3 ointment 1.0%
• Acyclovir cream 5%

Primary outcomes

• Clinician-assessed "Time to healing" — Up to 14 days

Countries

Israel