A Phase II Multicenter, Randomized, Double Blind Study to Assess the Safety, Tolerability and Efficacy of Two Concentrations of ZEP-3Na Topical Cream (0.1% and 1%) Compared to Vehicle-control in Subjects With Mild to Moderate Atopic Dermatitis With an Open Label Extension of up to 2 Weeks Treatment With ZEP-3Na Topical Cream 1%

NCT04307862 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Shulov Innovate for Science Ltd. 2012
Phase	Phase 2
Status	UNKNOWN
Enrolment	165
Start date	2019-12-29
Completion	2025-02

Conditions

• Atopic Dermatitis

Interventions

• ZEP-3Na 0.1%
• ZEP-3Na 1%
• Placebo Vehicle only

Primary outcomes

• • Proportion of subjects with IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ≥2 points during up to 4 weeks of double blind treatment — Up to 4 weeks
  Lower score of IGA mean better outcome, higher score mean worse outcome

Countries

Israel