Placebo Effect in the Treatment of Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: dimetindene; Behavioral: instruction; Other: conditioning

• Registration Number: NCT02094287
• Lead Sponsor: Margitta Worm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2013-11
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Study Completion: 2015-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
verum, instruction, conditioning	conditioning	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, conditioning	instruction	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.
placebo, instruction, conditioning	conditioning	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.
placebo, instruction, conditioning	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.
verum, instruction, no conditioning	instruction	This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied
verum, no instruction, no conditioning	dimetindene	Dimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given.
verum, instruction, conditioning	dimetindene	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	dimetindene	This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Charité - University Medicine Berlin; 🇩🇪 Berlin, Germany

University of Hamburg; 🇩🇪 Hamburg, Germany