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Completed

NCT Number: NCT02094287

Placebo Effect in the Treatment of Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - University Medicine Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dimetindene

Drug

receiving either dimetindene or a placebo (saline) via infusion

instruction

Behavioral

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

conditioning

Other

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

Other names: learning experience

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Margitta Worm

Other

Collaborators

  • University of Hamburg-Eppendorf

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Mar 21, 2014
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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