A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT01461941 |
Recruitment Status :
Completed
First Posted : October 28, 2011
Last Update Posted : March 1, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Drug: E6005 Drug: E6005 ointment (vehicle) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 78 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of E6005 in Patients With Atopic Dermatitis |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
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. |
- Changes of pruritus score from baseline [ Time Frame: From baseline through 12 weeks ]
- Changes of eczema area and severity from baseline [ Time Frame: From baseline through 12 weeks ]

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Ages Eligible for Study: | 20 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461941
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 |
Responsible Party: | Dermavant Sciences GmbH |
ClinicalTrials.gov Identifier: | NCT01461941 |
Other Study ID Numbers: |
E6005-J081-201 |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | March 1, 2018 |
Last Verified: | February 2018 |
Dermatitis Atopic |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |