NCT03859986

Study in Subjects With Moderate Atopic Dermatitis

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Ralexar Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The main objectives of this study are to: * Evaluate the safety of ALX-101 Gel 5% when applied topically twice daily in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle * Evaluate the efficacy of ALX-101 Gel 5% when applied topically twice daily in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle

Conditions

• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
DRUG	ALX-101 Gel Vehicle	ALX-101 Gel Vehicle
DRUG	ALX-101 Gel 5%	ALX-101 Gel 5%

Timeline

• Start date: 2019-03-08
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-03-01
• Last updated: 2019-11-05

Locations

22 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study