A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
1 other identifier
interventional
78
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2011
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 3, 2025
February 1, 2018
11 months
October 26, 2011
May 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes of pruritus score from baseline
From baseline through 12 weeks
Changes of eczema area and severity from baseline
From baseline through 12 weeks
Study Arms (2)
Drug: 0.2% E6005 ointment
EXPERIMENTALDrug: 0.0% E6005 ointment (vehicle)
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adults of both genders aged 20 to 64 years at the time when the written informed consent is obtained.
- Outpatients diagnosed with atopic dermatitis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Study Sites (10)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Urayasu-shi, Chiba, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Asahikawa-shi, Hokkaido, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Adachi-ku, Tokyo, Japan
Unknown Facility
Chiyoda-ku, Tokyo, Japan
Unknown Facility
Minato-ku, Tokyo, Japan
Unknown Facility
Shinagawa-ku, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2011
First Posted
October 28, 2011
Study Start
December 1, 2011
Primary Completion
November 1, 2012
Study Completion
January 1, 2013
Last Updated
June 3, 2025
Record last verified: 2018-02