MedTrace Logo

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

NCT03304470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-03-20

No results posted yet for this study

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

Interventions

DRUG

ATx201 2% Cream

Anhydrous Cream

DRUG

ATx201 Cream Vehicle

Anhydrous Cream

Sponsors & Collaborators

  • UNION therapeutics

    lead INDUSTRY

Principal Investigators

  • Philippe Prokocimer · Sponsor CMO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2018-03-05
Completion
2018-03-05

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304470 on ClinicalTrials.gov