Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01359787
• Collaborator: (none)
• Enrollment: 197
• Location: 1
• Arms: 4
• Duration (Months): 4
• Patients Per Site Per Month: 48.7

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis; Eczema	Drug: Mapracorat; Drug: Vehicle without active	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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)
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Eczema Area and Severity Index (EASI) [Over all study visits for up to 4 weeks]

Secondary Outcome Measures

1. Subjects´ assessment of pruritus [At baseline and after 4 weeks of treatment]

   Subjects´ assessment of pruritus using a visual analog scale (VAS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Berlin		Germany	10589

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01359787
• Other Study ID Numbers: 15616; 1403440; 2010-024279-14
• First Posted: May 25, 2011
• Last Update Posted: Jan 21, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Jan 21, 2015