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A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study To Evaluate The Safety And Efficacy Of ALX-101 Topical Gel Administered Twice Daily In Adult And Adolescent Subjects With Moderate Atopic Dermatitis
This is a Phase 2, randomized, double-blind, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of ALX-101 Gel 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 56 days in adult and adolescent subjects with moderate atopic dermatitis
Details
| Lead sponsor | Ralexar Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 124 |
| Start date | 2019-03-08 |
| Completion | 2020-01 |
Conditions
- Atopic Dermatitis Eczema
Interventions
- ALX-101 Gel Vehicle
- ALX-101 Gel 5%
Primary outcomes
- Eczema Area Severity Index (EASI) — Day 57
Mean change from baseline in EASI score at Week 8
Countries
United States, Canada