Placebo Effect in the Treatment of Atopic Dermatitis

Margitta Worm

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Drug: dimetindene; Behavioral: instruction; Other: conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02094287

2008-008474-31 (EudraCT Number)

PlacItch

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

166 participants in 4 patient groups

verum, instruction, conditioning

Experimental group

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.

Treatment:

Other: conditioning

Behavioral: instruction

Drug: dimetindene

verum, instruction, no conditioning

Experimental group

Description:

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

Treatment:

Behavioral: instruction

Drug: dimetindene

placebo, instruction, conditioning

Experimental group

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.

Treatment:

Other: conditioning

Behavioral: instruction

verum, no instruction, no conditioning

Experimental group

Description:

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

Treatment:

Drug: dimetindene