Phase
Condition
Eczema (Atopic Dermatitis)
Atopic Dermatitis
Allergy
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Women will be considered for inclusion if they are: not pregnant, as confirmed bypregnancy test (see flow chart) and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant,including any female who is pre-menarchial or post-menopausal, with documented proof ofhysterectomy or tubal ligation, or meet clinical criteria for menopause and has beenamenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potentialand using a highly effective method of contraception during the entire study (vasectomisedpartner, sexual abstinence - the lifestyle of the female should be such that there iscomplete abstinence from intercourse from two weeks prior to the first dose of studymedication until at least 72 hours after the last pollen challenge -, implants,injectables, combined oral contraceptives, hormonal Intra Uterine Devices (IUD) ordouble-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel,diaphragm, sponge, and cervical cap).
For patient groups 1 and 2: Positive Immunglobulin E (IgE) level for Dactylisglomerata of at least ImmunoCAP fluoroenzyme immunoassay (CAP FEIA) class 3 atscreening or within the last 12 months.
atopic dermatitis fulfilling the United Kingdom (UK) criteria of AD
SCORAD index between 20 and 50 points.
Forced expiratory Volume in 1 second (FEV1) ≥ 80% pred. at screening.
Smokers or non-smokers
Applicable only for patients of the control group: No IgE-sensitization to grasspollen (including Dactylis glomerata)
Exclusion
Exclusion Criteria:
Past or present disease, which as judged by the investigator, may affect the outcomeof this study. These diseases include, but are not limited to, cardiovascular disease,malignancy, hepatic disease, renal disease, hematological disease, neurologicaldisease, endocrine disease or pulmonary disease.
Asthma other than mild asthma which is treated with short acting beta-2-agonists onlyand which is controlled according to the current GINA (Global Initiative for Asthma)guidelines
Clinically relevant abnormalities in hematology or blood chemistry at screening.
Positive Human Immunodeficiency Virus Antibody (HIV-1/2Ab), hepatitis B surfaceantigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
Treatment with medication that might interfere with rescue medication for anaphylacticreactions (e.g. beta blocker).
Topical steroid treatment of air exposed skin (wash out phase: 2 weeks)
Topical calcineurin inhibitor treatment of air exposed skin (wash out phase: 2 weeks)
Ultraviolet (UV) radiation treatment (wash out phase: 4 weeks)
Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine,Mycophenolate Mofetil (MMF); wash out phase: 4 weeks)
Treatment with antihistamines (wash out phase: 1 week)
Specific immunotherapy (SIT) with grass pollen allergens within the last 5 years
Diastolic blood pressure above 95 mmHg.
Febrile illness within 2 weeks prior to screening.
Alcohol or drug abuse within 12 month prior to screening.
Regular daily consumption of more than 1 liter of usual beer or the equivalentquantity of approximately 40 g of alcohol in another form.
Participation in another clinical trial 30 days prior to enrolment.
Risk of non-compliance with study procedures.
Study Design
Study Description
Connect with a study center
Fraunhofer ITEM
Hannover, Niedersachsen 30625
GermanySite Not Available

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