Placebo Effect in the Treatment of Atopic Dermatitis

September 17, 2015 updated by: Margitta Worm

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - University Medicine Berlin
      • Hamburg, Germany, 20146
        • University of Hamburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: verum, instruction, 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.
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.
Other Names:
  • learning experience
Experimental: verum, instruction, no conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied
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
Experimental: placebo, instruction, 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.
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.
Other Names:
  • learning experience
Experimental: verum, no instruction, no 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the experimental pruritus intensity on a 10-point-rating scale between the groups
Time Frame: 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.
assessed over a time frame of 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups
Time Frame: assessed over a time frame of 2 days
Change of SCORAD is assessed on day 1 and day 2.
assessed over a time frame of 2 days
Changes of Wheal sizes experimentally provoked by skin prick test.
Time Frame: 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.
assessed over a time frame of 2 days
Changes of clinical, atopic itch intensity on a 10-point-rating scale
Time Frame: assessed over a time frame of 2 days
Changes of clinical itch intensity assessed on day 1 and day 2.
assessed over a time frame of 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Margitta Worm

Collaborators

University of Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PlacItch
  • 2008-008474-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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