A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
This study is ongoing, but not recruiting participants.
Sponsor:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01461941
First received: October 26, 2011
Last updated: October 15, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Drug: E6005 Drug: E6005 ointment (vehicle) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of E6005 in Patients With Atopic Dermatitis |
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Changes of pruritus score from baseline [ Time Frame: From baseline through 12 weeks ] [ Designated as safety issue: No ]
- Changes of eczema area and severity from baseline [ Time Frame: From baseline through 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 78 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Drug: 0.2% E6005 ointment |
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.
|
| Placebo Comparator: Drug: 0.0% E6005 ointment (vehicle) |
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 20 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461941
Locations
| Japan | |
| Nagoya-shi, Aichi, Japan | |
| Urayasu-shi, Chiba, Japan | |
| Fukuoka-shi, Fukuoka, Japan | |
| Asahikawa-shi, Hokkaido, Japan | |
| Sapporo-shi, Hokkaido, Japan | |
| Yokohama-shi, Kanagawa, Japan | |
| Adachi-ku, Tokyo, Japan | |
| Chiyoda-ku, Tokyo, Japan | |
| Minato-ku, Tokyo, Japan | |
| Shinagawa-ku, Tokyo, Japan | |
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
| Study Director: | Yasumi Kitahara | Eisai Co., Ltd. |
More Information
No publications provided
| Responsible Party: | Eisai Inc. ( Eisai Co., Ltd. ) |
| ClinicalTrials.gov Identifier: | NCT01461941 History of Changes |
| Other Study ID Numbers: | E6005-J081-201 |
| Study First Received: | October 26, 2011 |
| Last Updated: | October 15, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Eisai Inc.:
|
Dermatitis Atopic |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013