Back to resultsA Phase 2 Study of E6005 in Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
E6005
E6005 ointment (vehicle)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Dermatitis, Atopic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drug: 0.2% E6005 ointment
Drug: 0.0% E6005 ointment (vehicle)
Arm Description
Outcomes
Primary Outcome Measures
Changes of pruritus score from baseline
Changes of eczema area and severity from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT01461941
First Posted
October 26, 2011
Last Updated
February 28, 2018
Sponsor
Dermavant Sciences GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01461941
Brief Title
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
Official Title
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermavant Sciences GmbH
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Dermatitis, Atopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: 0.2% E6005 ointment
Arm Type
Experimental
Arm Title
Drug: 0.0% E6005 ointment (vehicle)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
E6005
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
E6005 ointment (vehicle)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of pruritus score from baseline
Time Frame
From baseline through 12 weeks
Title
Changes of eczema area and severity from baseline
Time Frame
From baseline through 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Nagoya-shi
State/Province
Aichi
Country
Japan
City
Urayasu-shi
State/Province
Chiba
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Asahikawa-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Adachi-ku
State/Province
Tokyo
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
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