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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ZEP-3Na | Unknown | 0.1 % | Topical |
| Subject | ZEP-3Na | Unknown | 1 % | Topical |