NCT04307862

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

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%

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Shulov Innovate for Science Ltd. 2012 · Industry
• Sex: All
• Age: 5 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

165 subjects, 5-75 years old with mild to moderate Atopic Dermatitis will be enrolled to the study. The investigational product which is the synthetic analogue of the natural compound found in the rattle snake venom will be administered topically twice daily. The duration of the study will be up to 11 weeks consisting of up to 3 weeks of screening, 4 weeks of double blind treatment, optional 2 weeks of open label treatment, followed by 2 weeks of follow-up. Efficacy will be measured by IGA (Investigator Global Assessment, EASI (Eczema Area and Severity Index) and SCORAD (SCORing Atopic Dermatitis). Lesions will be photographed throughout the study. Physical examination and vital signs will be measured during every visit. Patients will complete quality of life questionnaires, itching scale and diaries.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-29
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2020-03-13
• Last updated: 2023-09-13

Locations

10 sites across 1 country: Israel