A placebo-controlled, multicentre, double-blinded, intra-individual comparison to gain evidence of the safety, tolerability and efficacy of Prednicarbat cream and ointment in patients with active atopic dermatitis
- Conditions
- active atopic dermatitis (according to IGA score 1 - 4)MedDRA version: 9.1Level: LLTClassification code 10003639Term: Atopic dermatitis
- Registration Number
- EUCTR2009-012028-98-DE
- Lead Sponsor
- GALENpharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Male or female patients with a diagnosis of atopic dermatitis for = 6 months, in active stage (active stage means severity as measured by IGA-Score between 1 and 4, Definition of IGA in Appendix)
•At least two comparable areas of stable atopic eczema on bilateral symmetric corresponding sides of the extremities or the body (except for head and genital area), each of at least 10 cm², with a modified EASI score of the test areas > 6 and at least 60 % of the defined test areas afflicted with atopic dermatitis (Definition of modified EASI in Appendix)
•Age between 18 and 75 years
•A patient of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study:
oStrict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
oCombined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
oIntrauterine device (IUD) inserted for at least 1 month prior to study entrance
•Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere to concomitant therapy prohibitions of the test areas and must agree to avoid intense UV exposure of the test areas during the study
•Written Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•A general medical condition (including underlying dermatological diseases) that in the investigators opinion may confound the study assessments
•A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial (including but not limited to: serious infectious diseases, major surgery within the last 4 weeks, coronary artery disease, renal impairment, hepatic impairment, cancer, uncontrolled metabolic diseases, autoimmune diseases)
•Any condition other than atopic dermatitis or treatment that may interfere with the barrier skin function or may lead to dermatitis
•A condition of the skin in the test area that in the investigators opinion may confound the study assessments (e.g. extensive body hair, scars, tattoos, piercings) or may put the patient at risk (e.g. localized bacterial or viral infection, suspected Tinea, open wounds)
•The patient has exposed the test areas to excessive UV radiation (or UV therapy) within 1 month prior to baseline or is planning intense UV exposure during the study
•Very severe atopic dermatitis as measured by the IGA-Score 5 or, in the judgement of the investigator, an indication for a systemic anti-inflammatory therapy
•An indication for a topic therapy that requires topical treatment anywhere on the body with a corticosteroid more potent than Class II or more than 10 % of the body surface area or any non-corticosteroid anti-inflammatory topical treatment during the study
•Administration of any systemic drug indicated to treat atopic dermatitis (e.g. steroids, immunosuppressives such as ciclosporine, azathioprine, mycophenolatmofetile; leucotrien antagonists) within 1 month prior to study entry or during the study
•Systemic administration of antihistamines within 2 weeks prior to study entry and during the study
•Administration of any topical treatment (e.g. topical steroids, calcineurin inhibitors) in the region of the designated test areas within 2 weeks prior to study entry
•Administration of any other topical treatment (including cosmetic products) in the region of the designated test areas during the study
•Presence or history of a malignant skin disease (other than surgically removed basalioma or sufficiently treated actinic keratosis)
•Presence or history of any malignant disease (other than skin malignancy) in the last 10 years
•Known adverse reactions of any severity or hypersensitivity to any ingredient of the IMPs (in particular to Prednicarbat)
•Presence of cutaneous reactions as a result of vaccination
•Presence of cutaneous manifestation of tuberculosis, of syphilis or of viral infections (e.g. varicella)
•Presence of rosacea
•Presence of perioral dermatitis
•Presence of bacterial or mycotic dermal infections in the test areas
•Immunotherapy (e.g. allergen desensitisation) prior to and during the study
•Vaccination within 6 days prior to enrolment in the study and during the study
•A female patient with a positive urine pregnancy test at baseline (or if retested during the course of the study), is breast-feeding or is planning to become pregnant or breast-feed a child during the study
•Participation in any other clinical trial within 4 weeks prior or during this trial
•Patient is an adult under guardianship, deprived of freedom or unable to communicate or cooperate with the Investigator due to language or mental problems
•Patient is a suspected substance-abuser or is in the opinion of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method