Placebo Effect in the Treatment of Atopic Dermatitis

NCT ID: NCT02094287

Last Updated: 2015-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

dimetindene

Intervention Type DRUG

receiving either dimetindene or a placebo (saline) via infusion

instruction

Intervention Type BEHAVIORAL

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

conditioning

Intervention Type OTHER

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

verum, instruction, no conditioning

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

Group Type EXPERIMENTAL

dimetindene

Intervention Type DRUG

receiving either dimetindene or a placebo (saline) via infusion

instruction

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

instruction

Intervention Type BEHAVIORAL

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

conditioning

Intervention Type OTHER

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

verum, no instruction, no conditioning

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

Group Type EXPERIMENTAL

dimetindene

Intervention Type DRUG

receiving either dimetindene or a placebo (saline) via infusion

Interventions

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dimetindene

receiving either dimetindene or a placebo (saline) via infusion

Intervention Type DRUG

instruction

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

Intervention Type BEHAVIORAL

conditioning

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

Intervention Type OTHER

Other Intervention Names

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learning experience

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

Margitta Worm

OTHER

Sponsor Role lead

Responsible Party

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Margitta Worm

Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Margitta Worm, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité - University Medicine Berlin

Berlin, , Germany

Site Status

University of Hamburg

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2008-008474-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PlacItch

Identifier Type: -

Identifier Source: org_study_id

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