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| Name | Class |
|---|---|
| Hannover Medical School | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD, sensitized, treated | Active Comparator | Allergen challenge chamber and Treatment for 12 day with 'Eucerin AtopiControl Lotion' (for the body) and 'Eucerin AtopiControl facial cream' (for the face): 1,2 g twice daily. |
|
| AD, not sensitized, not treated | Experimental | Allergen challenge chamber |
|
| AD, sensitized, not treated | Experimental | Allergen challenge chamber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'Eucerin AtopiControl Lotion' (for the body) | Drug | Treatment with Eucerin AtopiControl Lotion |
|
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD Day 3 | Difference of change in objective SCORAD in treated versus untreated patients | Day 3: pre- 4 hour-challenge with grass pollen and post-4 hour-challenge with grass pollen |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD Day 1,2,4,5 | Difference of change in objective SCORAD in treated versus untreated patients | Day 1,2,4,5: pre- 4 hour -challenge with grass pollen and post-4 hour-challenge with grass pollen |
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Inclusion Criteria:
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 meet 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 first dose of study medication until at least 72 hours after the last pollen challenge -, implants, injectables, combined oral contraceptives, hormonal Intra Uterine Devices (IUD) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Hohlfeld, MD | The Fraunhofer-Gesellschaft | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraunhofer ITEM | Hanover | Lower Saxony | 30625 | Germany |
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The working hypothesis fo this study is, that local treatment with 'Eucerin AtopiControl Lotion' and 'Eucerin AtopiControl Gesichtscreme' compared to no treatment signifixantly reduces the increase of SCORAD that is elicited during challenge in an environmental challenge chamber (ECC) with grass pollen.
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| Allergen challenge chamber | Other | Exposure to Dactylis glomerata pollen in an environmental challenge chamber |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
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