NCT03304470

A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis

A Double-Blind, Randomized, Intraindividual, Vehicle-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Topically Applied ATx201 in Subjects With Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: UNION therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle controlled study, with each individual receiving both active and vehicle treatment. Approximately 30 subjects with moderate atopic dermatitis will receive topically applied ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands, and feet, ideally from the same anatomical location).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ATx201 2% Cream	Anhydrous Cream
DRUG	ATx201 Cream Vehicle	Anhydrous Cream

Timeline

• Start date: 2017-09-25
• Primary completion: 2018-03-05
• Completion: 2018-03-05
• First posted: 2017-10-09
• Last updated: 2018-03-20

Locations

1 site across 1 country: Canada