Placebo Effect in the Treatment of Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Placebo Effect in Atopic Dermatitis - Increase the Pharmacological Effect of Itching Caused by Classical Conditioning and Expectancy Processes: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094287
• Other study ID #: PlacItch
• Secondary ID: 2008-008474-31
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: September 17, 2015
• Start date: September 2010
• Est. completion date: February 2015

Study information

• Verified date: September 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: February 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• dimetindene
receiving either dimetindene or a placebo (saline) via infusion

Behavioral:
• instruction
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment

Other:
• conditioning
classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin	Berlin
Germany	University of Hamburg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Margitta Worm	University of Hamburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	assessed over a time frame of 2 days	No
Secondary	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	No