Atopic DermatitisPhase 2NCT01228513
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
A Phase 2 study testing ZK245186 in people with Atopic Dermatitis, run by Bayer at 16 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to placebo in the treatment of atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ZK245186
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Nov 2010to Apr 2012
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
- Body surface area affected by atopic dermatitis at or less than 15% at start of treatment
Who cannot join
- Pregnancy and breast-feeding
- Conditions that may pose a threat to the patient or effect the outcome of the study
- Wide-spread atopic dermatitis (AD) requiring systemic treatment
- Immuno-compromized conditions
- At least 2 weeks after local AD treatment and treatment with systemic antibiotics
- At least 1 month after systemic AD treatment
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States13 sites
Study site
Anaheim, California, 92801
Study site
Austin, Texas, 78759
Study site
Boise, Idaho, 83704
Study site
Boston, Massachusetts, 02114-2508
Study site
Chicago, Illinois, 60612
Study site
College Station, Texas, 77845
Study site
Fridley, Minnesota, 55432
Study site
Honolulu, Hawaii, 96813
Study site
New York, New York, 10029
Study site
Portland, Oregon, 97223
Study site
San Antonio, Texas, 78229
Study site
Warren, Michigan, 48088
Study site
Webster, Texas, 77598
Japan3 sites
Study site
Kawaguchi Saitama, 332-0031
Study site
Tokyo, 150-0034
Study site
Tokyo, 162-0053
About this study
Official title: Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of ZK245186 Ointment in Concentrations of 0.01, 0.03, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis (AD)
The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to placebo in the treatment of atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- ZK245186, Placebo (vehicle without active ingredient)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZK245186Drug
Also called Mapracorat (BAY86-5319)
Daily topical application
Placebo (vehicle without active ingredient)Drug
Daily topical application
| Study group | Role | What they receive |
|---|---|---|
| 0.01% ointment | Active comparator | Lowest concentration Receives: Drug: ZK245186 |
| 0.03% ointment | Active comparator | Middle concentration Receives: Drug: ZK245186 |
| 0.1% ointment | Active comparator | Highest concentration Receives: Drug: ZK245186 |
| Placebo (vehicle without active) | Placebo comparator | No active ingredient Receives: Drug: Placebo (vehicle without active ingredient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI)
Eczema area and severity index
Measured: At baseline
EASI
Ezcema area and severity index
Measured: Measured after one week of treatment
EASI
Eczema area and severity index
Measured: Measured at the end of 2 weeks of treatment
EASI
Eczema area and severity index
Measured: Measured at the end of 3 weeks of treatment
EASI
Eczema area and severity index
Measured: Measured at the end of 4 weeks of treatment
Secondary outcomes (5)
Subjects' assessment of pruritus
Subjective measurement on a point scale
Measured: Measured at baseline
Subject's assessment of pruritus
Subjective measurement on a point scale
Measured: Measured after one week of treatment
Subject's assessment of pruritus
Subjective measurement on a point scale
Measured: Measured after two weeks of treatment
Subject's assessment of pruritus
Subjective measurement on a point scale
Measured: Measured after three weeks of treatment
Subject's assessment of pruritus
Subjective measurement on a point scale
Measured: Measured after four weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionApr 2012
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.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228513
- Sponsor's protocol ID
- 15267
- Other IDs
- 1403380
- Status last verified
- Dec 2015
- First submitted
- 14 Oct 2010
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of ZK245186 Ointment in Concentrations of 0.01, 0.03, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT01228513
- Acronym / sponsor ID
- 15267
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Oct 2010 (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 of three concentrations of a development drug compared to placebo in the treatment of atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.01% ointment | Active comparator | Drug: ZK245186Lowest concentration |
| 0.03% ointment | Active comparator | Drug: ZK245186Middle concentration |
| 0.1% ointment | Active comparator | Drug: ZK245186Highest concentration |
| Placebo (vehicle without active) | Placebo comparator | Drug: Placebo (vehicle without active ingredient)No active ingredient |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
- Body surface area affected by atopic dermatitis at or less than 15% at start of treatment
Key exclusion criteria (6 listed)
- Pregnancy and breast-feeding
- Conditions that may pose a threat to the patient or effect the outcome of the study
- Wide-spread atopic dermatitis (AD) requiring systemic treatment
- Immuno-compromized conditions
- At least 2 weeks after local AD treatment and treatment with systemic antibiotics
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 |
|---|---|---|
| ZK245186Also: Mapracorat (BAY86-5319)Daily topical application | Drug | 0.01% ointment, 0.03% ointment, 0.1% ointment |
| Placebo (vehicle without active ingredient)Daily topical application | Drug | Placebo (vehicle without active) |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: At baseline
Eczema area and severity index
EASI
Time frame: Measured after one week of treatment
Ezcema area and severity index
EASI
Time frame: Measured at the end of 2 weeks of treatment
Eczema area and severity index
EASI
Time frame: Measured at the end of 3 weeks of treatment
Eczema area and severity index
EASI
Time frame: Measured at the end of 4 weeks of treatment
Eczema area and severity index
5 secondary outcomes
Subjects' assessment of pruritus
Time frame: Measured at baseline
Subject's assessment of pruritus
Time frame: Measured after one week of treatment
Subject's assessment of pruritus
Time frame: Measured after two weeks of treatment
Subject's assessment of pruritus
Time frame: Measured after three weeks of treatment
Subject's assessment of pruritus
Time frame: Measured after four weeks of treatment
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 21 Jan 2016.
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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.
Bayer Study Director study director
Bayer
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZK245186 in people with Atopic Dermatitis, run by Bayer at 16 sites in 2 countries.
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 6 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, 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?
Eczema Area and Severity Index (EASI) (time frame: At baseline). The study lists 5 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 21 Jan 2016.