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| Name | Class |
|---|---|
| Hannover Medical School | OTHER |
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This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to assess the effect of challenges with dactylis glomerata pollen in an environmental challenge chamber on dermal symptoms in patients suffering from atopic dermatitis.
After each challenge session and on Day 3, Day 4, and Day 5 blood samples will be taken for biomarker assessments. The severity of atopic dermatitis will be rated with the "SCORing Atopic Dermatitis" (SCORAD), with the objective SCORAD and with the assessment of itch and sleeplessness referring to the past 24 hours by a blinded observer (trained dermatologist) on each day including baseline assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Challenge with grass pollen | Experimental |
| |
| Challenge with clean air | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grass pollen : Dactylis glomerata | Other | The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with either 4000 pollen grains/m3 of dactylis glomerata pollen. |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD | Change in SCORAD between Day 1/ baseline (assessed 60 minutes prior to challenge) and Day 3 (assessed post-challenge) | Day 1/Baseline vs. Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD Day 4 and 5 | Change in SCORAD between Day 1 (assessed 60 minutes prior to challenge) and the Scorad on Day 4 and Day 5 (assessed post challenge). | Day 1/Baseline vs. Day 4 and 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Hohlfeld, MD, professor | The Fraunhofer-Gesellschaft | Principal Investigator |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Challenge with clean air | Other | The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air. |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |