drugset / Trial / NCT04307862

Safety, Tolerability and Efficacy of ZEP-3Na (0.1% or 1%) Compared to Placebo in Subjects With Mild to Moderate Atopic Dermatitis

NCT04307862 ↗

Phase 2 Unknown 165 enrolled Shulov Innovate for Science Ltd. 2012
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2019-12-29
Primary completion
2024-12
Completion
2025-02

Drugs

EvaluationDrugModalityDoseRoute
Subject ZEP-3Na Unknown 0.1 % Topical
Subject ZEP-3Na Unknown 1 % Topical

Indications