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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01359787

Enrollment

197

Registered

2011-05-25

Start date

2011-05-31

Completion date

2011-09-30

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Eczema

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).

Interventions

DRUGMapracorat

Daily topical application

DRUGVehicle without active

Daily topical application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Eczema Area and Severity Index (EASI)	Over all study visits for up to 4 weeks

Secondary

Measure	Time frame	Description
Subjects´ assessment of pruritus	At baseline and after 4 weeks of treatment	Subjects´ assessment of pruritus using a visual analog scale (VAS)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026