Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
DRUGdimetindene
receiving either dimetindene or a placebo (saline) via infusion
BEHAVIORALinstruction
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
OTHERconditioning
classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.
Sponsors
University of Hamburg-Eppendorf
Margitta Worm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* SCORAD-Score \< 50 points * basic experimental pruritus \>= 3 points on a numeric rating scale * no acute eczema on their forearms * no systemic treatments for skin diseases for at least four weeks * no topical treatment on their arms for at least two weeks
Exclusion criteria
* intake of antihistamines * pregnancy and lactation * serious dysfunctions of the liver, kidneys or thyroid * prostatic hyperplasia * patients with tumors, major cardiovascular diseases, immunosuppression * glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the experimental pruritus intensity on a 10-point-rating scale between the groups | assessed over a time frame of 2 days | The pruritus intensity is assessed at different time points during a time frame of 2 days. The results are compared between the groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups | assessed over a time frame of 2 days | Change of SCORAD is assessed on day 1 and day 2. |
| Changes of Wheal sizes experimentally provoked by skin prick test. | assessed over a time frame of 2 days | 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. |
| Changes of clinical, atopic itch intensity on a 10-point-rating scale | assessed over a time frame of 2 days | Changes of clinical itch intensity assessed on day 1 and day 2. |
Countries
Germany
Outcome results
None listed