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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
166
receiving either dimetindene or a placebo (saline) via infusion
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.
Charité - University Medicine Berlin
Berlin, Germany
University of Hamburg
Hamburg, Germany
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.
Time frame: assessed over a time frame of 2 days
Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups
Change of SCORAD is assessed on day 1 and day 2.
Time frame: assessed over a time frame of 2 days
Changes of Wheal sizes experimentally provoked by skin prick test.
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.
Time frame: 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.
Time frame: assessed over a time frame of 2 days
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