The objective of this study is to assess the effect of 'Eucerin AtopiControl LOTION' and 'Eucerin AtopiControl facial cream' on dermal symptoms in patients with Atopic Dermatitis (AD) after two 4 h challenges with grass pollen on two consecutive days. In addition, this clinical study with exposure of Dactyls glomerate-sensitized Patients with AD shall be used to compare the skin response with AD Patients not-sensitized to Dactylis glomerata to understand the specificity of the grass pollen exposure.
After the screening assessments the subject's whole skin will be treated for a period of 12 days with either 'Eucerin AtopiControl LOTION' or 'Eucerin AtopiControl facial cream' or will receive no treatment until Day 1 of the study. All patients will be challenged for 4 hours on two consecutive days (Day1 and 2) with 4000 pollen grains/m³ of Dactylis glomerata pollen. In this study approximately 9 subjects will be placed in the Environmental Exposure Chamber (ECC) at a time. At screening a blood sample will be taken for determination mutations of genes encoding for skin barrier proteins (e.g. filaggrin mutation). At day 1 and day 5 blood samples (serum) will be taken for biomarker assessments and lymphocyte proliferation assays (peripheral blood). The severity of atopic dermatitis will be rated (blinded observer, trained dermatologist) applying the 'SCORing Atopic Dermatitis (SCORAD) index, the objective SCORAD, local SCORAD and Investigator Global assessment (IGA). Assessment of itch and sleeplessness referring to the past 24 hous will be done by a blinded observer on each day including baseline assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
23
Treatment with Eucerin AtopiControl Lotion
Exposure to Dactylis glomerata pollen in an environmental challenge chamber
Fraunhofer ITEM
Hanover, Lower Saxony, Germany
SCORAD Day 3
Difference of change in objective SCORAD in treated versus untreated patients
Time frame: Day 3: pre- 4 hour-challenge with grass pollen and post-4 hour-challenge with grass pollen
SCORAD Day 1,2,4,5
Difference of change in objective SCORAD in treated versus untreated patients
Time frame: Day 1,2,4,5: pre- 4 hour -challenge with grass pollen and post-4 hour-challenge with grass pollen
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