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

NCT04307862 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2023-09-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ZEP-3Na 0.1%

The Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase

DRUG

ZEP-3Na 1%

The Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase, with optional 2 weeks of open label with ZEP-3Na 1%.

DRUG

Placebo Vehicle only

he Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase

Sponsors & Collaborators

  • Shulov Innovate for Science Ltd. 2012

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-29
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307862 on ClinicalTrials.gov