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Trial record 13 of 33551 for:    Placebo AND placebo effect

Placebo Effect in the Treatment of Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02094287
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : September 18, 2015
Sponsor:
Collaborator:
University of Hamburg
Information provided by (Responsible Party):
Margitta Worm, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: dimetindene Behavioral: instruction Other: conditioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : September 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

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 Name: 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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094287


Locations
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Germany
Charité - University Medicine Berlin
Berlin, Germany, 10117
University of Hamburg
Hamburg, Germany, 20146
Sponsors and Collaborators
Margitta Worm
University of Hamburg
Investigators
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Principal Investigator: Margitta Worm, Prof. Dr. Charite University, Berlin, Germany

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Responsible Party: Margitta Worm, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02094287     History of Changes
Other Study ID Numbers: PlacItch
2008-008474-31 ( EudraCT Number )
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Physiological Effects of Drugs
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dimethindene
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents