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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
Sponsor:
Information provided by (Responsible Party):
Dermavant Sciences GmbH

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: E6005 Drug: E6005 ointment (vehicle) Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes of pruritus score from baseline [ Time Frame: From baseline through 12 weeks ]
  2. Changes of eczema area and severity from baseline [ Time Frame: From baseline through 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
Dermavant Sciences GmbH
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dermavant Sciences GmbH
ClinicalTrials.gov Identifier: NCT01461941     History of Changes
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

Keywords provided by Dermavant Sciences GmbH:
Dermatitis
Atopic

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