Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatit… (NCT05019209) | Clinical Trial Compass
CompletedNot Applicable
Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatitis Patients
Germany23 participantsStarted 2021-09-10
Plain-language summary
The present study investigates the reaction of the skin upon exposure to house dust mite (HDM) in patients with atopic dermatitis who have antibodies against HDM in the blood. A further aim is to assess nasal symptoms after exposure to HDM in an allergen challenge chamber and compare the results with data from previous studies.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Able and willing to give written informed consent.
✓. Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are:
✓. Not pregnant, as confirmed by pregnancy 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 of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
✓. Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the start of the study until at least 72 hours after the last study visit -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
✓. Positive IgE level for HDM of at least CAP FEIA class 3 (≥3,50 kU/l) at screening or in previous year.
✓. Atopic dermatitis fulfilling the UK criteria of AD
✓. SCORAD index between 20 and 50 points.
Exclusion criteria
✕. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs or lung function at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study
What they're measuring
1
Change in the objective SCORAD
Timeframe: Baseline assessment on Day 4 and immediately after exposure in allergen challenge chamber
Trial details
NCT IDNCT05019209
SponsorFraunhofer-Institute of Toxicology and Experimental Medicine
✕. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease.
✕. Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA guidelines
✕. Subject with concomitant allergies to seasonal aeroallergens which become active (i.e., grass, trees, weeds, rye; defined as being symptomatic to aeroallergens within the past 2 years or within the past 2 allergy seasons) during the individual study participation.
✕. Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening or test not performed.
✕. Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
✕. Topical steroid treatment (wash out phase: 2 weeks before day 1)
✕. Topical calcineurin inhibitor treatment (wash out phase 2 weeks before day 1)