Double-blind, randomized, vehicle-controlled, multicenter, multinational, parallel-group study of the efficacy and safety of mapracorat ointment in concentrations of 0.01%, 0.03% and 0.1% over max. 4 weeks in subjects with Atopic Dermatitis (AD) - Efficacy and safety of different concentrations of mapracorat in AD

• Conditions: Atopic Dermatitis; MedDRA version: 13.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-024279-14-DE
• Lead Sponsor: Intendis GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-14
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Subjects must fulfill all of the following criteria before inclusion in the study:

1 Signed written informed consent
2 Male or female out-patient subject 18 to 65 years of age at screening (female subject either using an accepted effective method of contraception (failure rate of
< 1%,) or of non-childbearing potential, (this means post menopausal -one year without menstrual period))
3 Diagnosis of AD according to Hanifin and Rajka Criteria (Hanifin and Rajka 1980)
4 Static Investigator’s Global Assessment score = 3, corresponding to at least moderate AD at screening and start of treatment
5 Atopic dermatitis involving a minimum of 5% body surface area at screening and start of treatment
6 Willingness of subject to follow all study procedures
7 Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

All parameters will be determined during the screening and baseline visit prior to first administration of the investigational product if not otherwise stated.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Subjects are to be excluded from the study if they display any of the following criteria:

Medical and surgical history
1 Pregnancy or lactation
2 Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
3 Clinically manifested immunosuppressive disorder or known history of malignant disease
4 Known hypersensitivity to any of the constituents or excipients of the investigational product (e.g. paraffin) or history of relevant drug and/or food allergies
Medication, drug use and special behavioral patterns
5 Use of any prescription or non-prescription medication prior to baseline that could interfere with evaluations in the study
• At least 3 months have passed since any systemic interferon, immunomodulating or immunosuppressive treatment (excluding systemic AD therapy as listed in the following point)
• At least 1 month has passed since any use of systemic AD therapy, in particular systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
• At least 2 weeks have passed since any local AD therapy, e.g. corticosteroids or topical immunomodulators
• At least 2 weeks have passed since systemic or topical antibiotics
• At least 1 week has passed since use of local anti-itch therapy (for example atopiclair)

Physical examination
6 Concomitant medical or dermatological disorder(s), which could interfere with the investigator’s ability to evaluate the subject’s response to the investigational product, e.g. chicken pox, impetigo, corticosteroid-induced perioral dermatitis, tinea corporis/tinea intertriginosa, recurrent active herpes simplex, head lice or scabies
Laboratory examination
7 Clinically relevant deviation in values for biochemistry, hematology, coagulation or urinalysis as judged by the investigator

Other
8 Mental handicap, legal incapacity or limited legal capacity leading to inability to give informed consent, subject is institutionalized because of legal or regulatory order
9 Subject is a dependent person, this means a relative/family member of the investigator and/or a member of the investigator’s staff
10 Participation in another clinical research study within 4 weeks before enrollment in this study.
11 Previous assignment to treatment during this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified