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

  • STATUS
    Recruiting
  • participants needed
    165
  • sponsor
    Shulov Innovate for Science Ltd. 2012
Updated on 29 January 2022
atopy

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 12 weeks.

The purpose of this study is to assess the safety, tolerability and efficacy of two concentrations of ZEP-3NA compared to vehicle-control.

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 17 weeks consisting of up to 3 weeks of screening, 12 weeks of 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.

Details
Condition Eczema, Eczema (Atopic Dermatitis - Pediatric), ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), ATOPIC DERMATITIS, Dermatitis, Atopic, Dermatite Atopique, Eczéma (Dermatite Atopique), Dermatitis, Hand Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Eczéma (Dermatite Atopique), Dermatite Atopique
Treatment ZEP-3Na
Clinical Study IdentifierNCT04307862
SponsorShulov Innovate for Science Ltd. 2012
Last Modified on29 January 2022

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