Placebo Effect in the Treatment of Atopic Dermatitis

NCT02094287 | Completed

• 2 other identifiers: PlacItch2008-008474-31
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  assessed over a time frame of 2 days

Secondary Outcomes (3)

• Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups

  assessed over a time frame of 2 days

• Changes of Wheal sizes experimentally provoked by skin prick test.

  assessed over a time frame of 2 days

• Changes of clinical, atopic itch intensity on a 10-point-rating scale

  assessed over a time frame of 2 days

Study Arms (4)

verum, instruction, conditioning

EXPERIMENTAL

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; Behavioral: instruction; Other: conditioning

verum, instruction, no conditioning

EXPERIMENTAL

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

Drug: dimetindene; Behavioral: instruction

placebo, instruction, conditioning

EXPERIMENTAL

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; Other: conditioning

verum, no instruction, no conditioning

EXPERIMENTAL

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

Drug: dimetindene

Interventions

dimetindene DRUG

receiving either dimetindene or a placebo (saline) via infusion

verum, instruction, conditioning; verum, instruction, no conditioning; verum, no instruction, no conditioning

instruction 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; verum, instruction, conditioning; verum, instruction, no conditioning

conditioning OTHER

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

Also known as: learning experience

placebo, instruction, conditioning; verum, instruction, conditioning

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• intake of antihistamines
• pregnancy and lactation
• serious dysfunctions of the liver, kidneys or thyroid
• prostatic hyperplasia
• patients with tumors, major cardiovascular diseases, immunosuppression
• glaucoma

Sponsors & Collaborators

• Margitta Worm: lead
• University of Hamburg-Eppendorf: collaborator

Study Sites (2)

Charité - University Medicine Berlin

Berlin, 10117, Germany

Location

University of Hamburg

Hamburg, 20146, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Dimethindene; Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Socioeconomic Factors; Population Characteristics

Study Officials

• Margitta Worm, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 21, 2014
• Study Start: September 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

DE (2)