A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: E6005; Drug: E6005 ointment (vehicle)

• Registration Number: NCT01461941
• Lead Sponsor: Dermavant Sciences GmbH

Brief Summary

The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after topical application of E6005 is also assessed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Study Start: 2011-12
• Primary Completion: 2012-11
• Study Completion: 2013-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: 0.2% E6005 ointment	E6005	-
Drug: 0.0% E6005 ointment (vehicle)	E6005 ointment (vehicle)	-

Primary Outcome Measures

Name	Time	Method
Changes of pruritus score from baseline	From baseline through 12 weeks
Changes of eczema area and severity from baseline	From baseline through 12 weeks