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A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01461941
First received: October 26, 2011
Last updated: January 31, 2014
Last verified: January 2014
  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
Study Completion Date: January 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 31, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Dermatitis
Atopic

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 27, 2014