Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
This study has been completed.
Sponsor:
Intendis GmbH
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT01359787
First received: May 23, 2011
Last updated: July 23, 2012
Last verified: December 2010
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis Eczema |
Drug: Mapracorat Drug: Vehicle without active |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Intendis GmbH:
Primary Outcome Measures:
- Eczema Area and Severity Index (EASI) [ Time Frame: Over all study visits for up to 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Subjects´ assessment of pruritus [ Time Frame: At baseline and after 4 weeks of treatment ] [ Designated as safety issue: No ]Subjects´ assessment of pruritus using a visual analog scale (VAS)
| Enrollment: | 197 |
| Study Start Date: | May 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mapracorat 0.01% Ointment
Lowest concentration
|
Drug: Mapracorat
Daily topical application
|
|
Active Comparator: Mapracorat 0.03% Ointment
Middle concentration
|
Drug: Mapracorat
Daily topical application
|
|
Active Comparator: Mapracorat 0.1% Ointment
Highest concentration
|
Drug: Mapracorat
Daily topical application
|
| Placebo Comparator: Vehicle without active |
Drug: Vehicle without active
Daily topical application
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Kathrin Vick, Study Director, Intendis GmbH |
| ClinicalTrials.gov Identifier: | NCT01359787 History of Changes |
| Other Study ID Numbers: | 1403440 |
| Study First Received: | May 23, 2011 |
| Last Updated: | July 23, 2012 |
| Health Authority: | Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Latvia: State Agency of Medicines Poland: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on May 23, 2013