Atopic DermatitisPhase 2NCT01359787
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
A Phase 2 study testing Mapracorat in people with Atopic Dermatitis and Eczema, run by Bayer at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Mapracorat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Sep 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
- Willingness of subject to follow all study procedures
- Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
Who cannot join
- Pregnancy and breast-feeding
- Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
- Clinically manifested immunosuppressive disorder or known history of malignant disease
- History of relevant drug and/or food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of Mapracorat Ointment in Three Concentrations Over Max. 4 Weeks in Subjects 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 ointment base (vehicle) in subjects with Atopic Dermatitis (AD).
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Mapracorat, Vehicle without active
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapracoratDrug
Daily topical application
Vehicle without activeDrug
Daily topical application
| Study group | Role | What they receive |
|---|---|---|
| Mapracorat 0.01% Ointment | Active comparator | Lowest concentration Receives: Drug: Mapracorat |
| Mapracorat 0.03% Ointment | Active comparator | Middle concentration Receives: Drug: Mapracorat |
| Mapracorat 0.1% Ointment | Active comparator | Highest concentration Receives: Drug: Mapracorat |
| Vehicle without active | Placebo comparator | Not described Receives: Drug: Vehicle without active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI)
Measured: Over all study visits for up to 4 weeks
Secondary outcomes (1)
Subjects´ assessment of pruritus
Subjects´ assessment of pruritus using a visual analog scale (VAS)
Measured: At baseline and after 4 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 posted25 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- 197 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
- NCT01359787
- Sponsor's protocol ID
- 15616
- Other IDs
- 1403440, 2010-024279-14
- Status last verified
- Jan 2015
- First submitted
- 23 May 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. 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 Mapracorat Ointment in Three Concentrations Over Max. 4 Weeks in Subjects With Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT01359787
- Acronym / sponsor ID
- 15616
- Conditions
- Atopic Dermatitis, Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 May 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 of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).
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 |
|---|---|---|
| Mapracorat 0.01% Ointment | Active comparator | Drug: MapracoratLowest concentration |
| Mapracorat 0.03% Ointment | Active comparator | Drug: MapracoratMiddle concentration |
| Mapracorat 0.1% Ointment | Active comparator | Drug: MapracoratHighest concentration |
| Vehicle without active | Placebo comparator | Drug: Vehicle without active |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent
- Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
- Willingness of subject to follow all study procedures
- Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
Key exclusion criteria (4 listed)
- Pregnancy and breast-feeding
- Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
- Clinically manifested immunosuppressive disorder or known history of malignant disease
- History of relevant drug and/or food allergies
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 |
|---|---|---|
| MapracoratDaily topical application | Drug | Mapracorat 0.01% Ointment, Mapracorat 0.03% Ointment, Mapracorat 0.1% Ointment |
| Vehicle without activeDaily topical application | Drug | Vehicle without active |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: Over all study visits for up to 4 weeks
1 secondary outcome
Subjects´ assessment of pruritus
Time frame: At baseline and after 4 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 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mapracorat in people with Atopic Dermatitis and Eczema, run by Bayer at 1 site in Germany.
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 4 inclusion and 4 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 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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: Over all study visits for up to 4 weeks). 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 2015.