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Placebo Effect in the Treatment of Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
dimetindene
instruction
conditioning
Sponsored by
Margitta Worm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité - University Medicine Berlin
  • University of Hamburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

verum, instruction, conditioning

verum, instruction, no conditioning

placebo, instruction, conditioning

verum, no instruction, no conditioning

Arm Description

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.

This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied

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.

Dimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups
Change of SCORAD is assessed on day 1 and day 2.
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.
Changes of clinical, atopic itch intensity on a 10-point-rating scale
Changes of clinical itch intensity assessed on day 1 and day 2.

Full Information

First Posted
March 17, 2014
Last Updated
September 17, 2015
Sponsor
Margitta Worm
Collaborators
University of Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT02094287
Brief Title
Placebo Effect in the Treatment of Atopic Dermatitis
Official Title
Placebo Effect in Atopic Dermatitis - Increase the Pharmacological Effect of Itching Caused by Classical Conditioning and Expectancy Processes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Margitta Worm
Collaborators
University of Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
verum, instruction, conditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
verum, instruction, no conditioning
Arm Type
Experimental
Arm Description
This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied
Arm Title
placebo, instruction, conditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
verum, no instruction, no conditioning
Arm Type
Experimental
Arm Description
Dimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given.
Intervention Type
Drug
Intervention Name(s)
dimetindene
Intervention Description
receiving either dimetindene or a placebo (saline) via infusion
Intervention Type
Behavioral
Intervention Name(s)
instruction
Intervention Description
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
Intervention Type
Other
Intervention Name(s)
conditioning
Other Intervention Name(s)
learning experience
Intervention Description
classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.
Primary Outcome Measure Information:
Title
Comparison of the experimental pruritus intensity on a 10-point-rating scale between the groups
Description
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
Secondary Outcome Measure Information:
Title
Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups
Description
Change of SCORAD is assessed on day 1 and day 2.
Time Frame
assessed over a time frame of 2 days
Title
Changes of Wheal sizes experimentally provoked by skin prick test.
Description
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
Title
Changes of clinical, atopic itch intensity on a 10-point-rating scale
Description
Changes of clinical itch intensity assessed on day 1 and day 2.
Time Frame
assessed over a time frame of 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margitta Worm, Prof. Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - University Medicine Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University of Hamburg
City
Hamburg
ZIP/Postal Code
20146
Country
Germany

12. IPD Sharing Statement

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Placebo Effect in the Treatment of Atopic Dermatitis

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