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NCT01461941 Clinical Trial

A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01461941
Other study ID # E6005-J081-201
Secondary ID
Status Completed
Phase Phase 2
First received October 26, 2011
Last updated February 28, 2018
Start date December 2011
Est. completion date January 2013

Study information
Verified date February 2018
Source Dermavant Sciences GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date January 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 20 Years to 64 Years
Eligibility Inclusion Criteria

- Adults of both genders aged 20 to 64 years at the time when the written informed consent is obtained.

- Outpatients diagnosed with atopic dermatitis.

Exclusion Criteria

- Patients with a present illness of Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo contagious, psoriasis, connective tissue disorder, collagen disorder or Netherton's syndrome, etc., which could have an effect on the pathological evaluation of the atopic dermatitis.

- Patients with active infection that requires oral or intravenous administration of antibiotics, antifungal or antivirus agent/s at baseline.

- Patients with advanced disease or abnormal laboratory tests that would possibly affect the safety of the subject or the implementation of this study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• E6005
0.0% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.
• E6005 ointment (vehicle)
0.2% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Dermavant Sciences GmbH

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes of pruritus score from baseline From baseline through 12 weeks
Primary Changes of eczema area and severity from baseline From baseline through 12 weeks
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