A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

May 28, 2025 updated by: Organon and Co
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan
    • Chiba
      • Urayasu-shi, Chiba, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Japan
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan
    • Tokyo
      • Adachi-ku, Tokyo, Japan
      • Chiyoda-ku, Tokyo, Japan
      • Minato-ku, Tokyo, Japan
      • Shinagawa-ku, Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of pruritus score from baseline
Time Frame: From baseline through 12 weeks
From baseline through 12 weeks
Changes of eczema area and severity from baseline
Time Frame: From baseline through 12 weeks
From baseline through 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimated)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E6005-J081-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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