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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008474-31 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Hamburg-Eppendorf | OTHER |
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The study is initiated in the indication of atopic dermatitis to study the impact of placebo in the treatment of pruritus. Classical conditioning and expectation via instructions/anticipation maintain the effect of placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| verum, instruction, conditioning | Experimental | This group received dimetindene and instructions about dimetindene and its effectiveness. One classical conditioning process with saline was applied during the skin prick test procedures. |
|
| verum, instruction, no conditioning | Experimental | This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied |
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| placebo, instruction, conditioning | Experimental | This group received a placebo (saline) as intravenously administered substance. But instructions about receiving dimetindene and its effectiveness were given. One classical conditioning process was applied during the skin prick test procedures. |
|
| verum, no instruction, no conditioning | Experimental | Dimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimetindene | Drug | receiving either dimetindene or a placebo (saline) via infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the experimental pruritus intensity on a 10-point-rating scale between the groups | The pruritus intensity is assessed at different time points during a time frame of 2 days. The results are compared between the groups. | assessed over a time frame of 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups | Change of SCORAD is assessed on day 1 and day 2. | assessed over a time frame of 2 days |
| Changes of Wheal sizes experimentally provoked by skin prick test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margitta Worm, Prof. Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - University Medicine Berlin | Berlin | 10117 | Germany | |||
| University of Hamburg |
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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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| ID | Term |
|---|---|
| D004115 | Dimethindene |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| instruction | Behavioral | information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment |
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| conditioning | Other | classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience. |
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The changes of wheal sizes due to the administered intervention at different time point during a time frame of 2 day is assessed in square millimeters. The results are compared between the groups.
| assessed over a time frame of 2 days |
| Changes of clinical, atopic itch intensity on a 10-point-rating scale | Changes of clinical itch intensity assessed on day 1 and day 2. | assessed over a time frame of 2 days |
| Hamburg |
| 20146 |
| Germany |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |