An interventional study of dimetindene and instruction in Atopic Dermatitis, sponsored by Margitta Worm. Completed at 2 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-18.
Sponsored by Margitta Worm · Not applicable, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 166 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Margitta Worm is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: dimetindene · Behavioral: instruction · Other: conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied
Drug: dimetindene · Behavioral: instruction
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.
Behavioral: instruction · Other: conditioning
Dimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given.
Drug: dimetindene
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.
Also known as: learning experience
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
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Margitta Worm