Atopic DermatitisPhase 2NCT01461941
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
A Phase 2 study testing E6005 in people with Atopic Dermatitis, run by Organon and Co at 10 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- E6005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 10 sitesJapan
- Study dates
- Dec 2011to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults of both genders aged 20 to 64 years at the time when the written informed consent is obtained.
- Outpatients diagnosed with atopic dermatitis.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Study site
Adachi-ku, Tokyo
Study site
Asahikawa-shi, Hokkaido
Study site
Chiyoda-ku, Tokyo
Study site
Fukuoka, Fukuoka
Study site
Minato-ku, Tokyo
Study site
Nagoya, Aichi-ken
Study site
Sapporo, Hokkaido
Study site
Shinagawa-ku, Tokyo
Study site
Urayasu-shi, Chiba
Study site
Yokohama, Kanagawa
About this study
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.
- Conditions
- Atopic Dermatitis
- Being tested
- E6005, E6005 ointment (vehicle)
- Keywords
- Dermatitis, Atopic
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6005Drug
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.
E6005 ointment (vehicle)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug: 0.2% E6005 ointment | Experimental | Not described Receives: Drug: E6005 |
| Drug: 0.0% E6005 ointment (vehicle) | Placebo comparator | Not described Receives: Drug: E6005 ointment (vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of pruritus score from baseline
Measured: From baseline through 12 weeks
Changes of eczema area and severity from baseline
Measured: From baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461941
- Sponsor's protocol ID
- E6005-J081-201
- Status last verified
- Feb 2018
- First submitted
- 26 Oct 2011
- Last updated
- 3 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of E6005 in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01461941
- Acronym / sponsor ID
- E6005-J081-201
- Conditions
- Atopic Dermatitis
- Keywords
- Dermatitis, Atopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: 0.2% E6005 ointment | Experimental | Drug: E6005 |
| Drug: 0.0% E6005 ointment (vehicle) | Placebo comparator | Drug: E6005 ointment (vehicle) |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults of both genders aged 20 to 64 years at the time when the written informed consent is obtained.
- Outpatients diagnosed with atopic dermatitis.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E60050.0% 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. | Drug | Drug: 0.2% E6005 ointment |
| 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. | Drug | Drug: 0.0% E6005 ointment (vehicle) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E6005 in people with Atopic Dermatitis, run by Organon and Co at 10 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of pruritus score from baseline (time frame: From baseline through 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.