NCT03175354

A Study in Subjects With Moderate Atopic Dermatitis

A Multicenter, Randomized, Double-Blind, Bilateral, Vehicle-Controlled Study of the Safety and Efficacy of ALX-101 Topical Gel Administered Twice Daily in Adult and Adolescent Subjects With Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Ralexar Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of ALX-101 Gel 1.5% and 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 42 days to adult and adolescent subjects with moderate atopic dermatitis.

Detailed description

The main objectives of this study are to: * Evaluate the safety and tolerability of ALX-101 Gel 1.5% and 5% when applied topically in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle * Evaluate the dose-response relationship of ALX-101 Gel 1.5% and 5% when applied topically twice daily in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle.

Conditions

• Atopic Dermatitis
• Eczema, Atopic

Interventions

Type	Name	Description
DRUG	ALX-101 Gel 1.5% and ALX-101 Gel Vehicle	Bilateral application of ALX-101 Gel 1.5% and ALX-101 Gel Vehicle
DRUG	ALX-101 Gel 5% and ALX-101 Gel Vehicle	Bilateral application of ALX-101 Gel 5% and ALX-101 Gel Vehicle

Timeline

• Start date: 2017-04-26
• Primary completion: 2018-06-29
• Completion: 2018-06-29
• First posted: 2017-06-05
• Last updated: 2018-10-25

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study