S.I.S. Shulov Innovative Science Ltd.

This is a phase II, double blind study with ZEP-3NA 0.1% or 1% vs. vehicle-control in subjects with mild to moderate Atopic Dermatitis. The IP (Investigational Product) will be administered topically twice daily for 4 weeks in the double blind phase. patients that will reach the primary endpoint will have the opportunity for additional to two weeks of open label treatment with ZEP-3Na 1%.
The purpose of this study is to assess the safety, tolerability and efficacy of two concentrations of ZEP-3NA compared to vehicle-control.

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.

It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream, administered topically up to 5 consecutive treatment days in healthy volunteers.
This is a single center trial. It is anticipated that the study will be conducted at the Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.
The screening/enrollment visit includes a PK study for 24h following a single IP topical application. After a 24h washout time break, the subject will enter the treatment period for 5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of treatment.