Atopic DermatitisNCT02094287
Placebo Effect in the Treatment of Atopic Dermatitis
A study testing dimetindene, instruction and conditioning in people with Atopic Dermatitis, run by Margitta Worm at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- dimetindene, instruction and conditioning
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Germany2 sites
Charité - University Medicine Berlin
Berlin, 10117
University of Hamburg
Hamburg, 20146
About this study
Official title: Placebo Effect in Atopic Dermatitis - Increase the Pharmacological Effect of Itching Caused by Classical Conditioning and Expectancy Processes: A Randomized Controlled Trial
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
- Being tested
- dimetindene, instruction, conditioning
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimetindeneDrug
receiving either dimetindene or a placebo (saline) via infusion
instructionBehavioural
information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
conditioningOther
Also called learning experience
classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Behavioral: instruction; Other: conditioning |
| verum, no instruction, no conditioning | Experimental | Dimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given. Receives: Drug: dimetindene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed over a time frame of 2 days
Secondary outcomes (3)
Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups
Change of SCORAD is assessed on day 1 and day 2.
Measured: assessed over a time frame of 2 days
Changes of Wheal sizes experimentally provoked by skin prick test.
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.
Measured: assessed over a time frame of 2 days
Changes of clinical, atopic itch intensity on a 10-point-rating scale
Changes of clinical itch intensity assessed on day 1 and day 2.
Measured: assessed over a time frame of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startSep 2010
- Primary completionNov 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Margitta Worm
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hamburg-Eppendorf
- Responsible party
- Sponsor-investigator, Margitta Worm, Charite University, Berlin, Germany
- Investigators
- Margitta Worm, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094287
- Sponsor's protocol ID
- PlacItch
- Other IDs
- 2008-008474-31, 2008
- Status last verified
- Sep 2015
- First submitted
- 17 Mar 2014
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Effect in Atopic Dermatitis - Increase the Pharmacological Effect of Itching Caused by Classical Conditioning and Expectancy Processes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02094287
- Acronym / sponsor ID
- PlacItch
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Margitta WormUniversity, hospital or other
- Collaborators
- University of Hamburg-Eppendorf
- Study start
- Sep 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| verum, instruction, conditioning | Experimental | Drug: dimetindene, Behavioral: instruction, Other: conditioningThis group received dimetindene and instructions about dimetindene and its effectiveness. One classical conditioning process with saline was applied during the skin prick test procedures. |
| verum, instruction, no conditioning | Experimental | Drug: dimetindene, Behavioral: instructionThis group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied |
| placebo, instruction, conditioning | Experimental | Behavioral: instruction, Other: conditioningThis 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. |
| verum, no instruction, no conditioning | Experimental | Drug: dimetindeneDimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- intake of antihistamines
- pregnancy and lactation
- serious dysfunctions of the liver, kidneys or thyroid
- prostatic hyperplasia
- patients with tumors, major cardiovascular diseases, immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dimetindenereceiving either dimetindene or a placebo (saline) via infusion | Drug | verum, instruction, conditioning, verum, instruction, no conditioning, verum, no instruction, no conditioning |
| instructioninformation about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment | Behavioural | placebo, instruction, conditioning, verum, instruction, conditioning, verum, instruction, no conditioning |
| conditioningAlso: learning experienceclassical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience. | Other | placebo, instruction, conditioning, verum, instruction, conditioning |
Primary outcome
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.
3 secondary outcomes
Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups
Time frame: assessed over a time frame of 2 days
Changes of Wheal sizes experimentally provoked by skin prick test.
Time frame: assessed over a time frame of 2 days
Changes of clinical, atopic itch intensity on a 10-point-rating scale
Time frame: assessed over a time frame of 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margitta Worm, Prof. Dr. principal investigator
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dimetindene, instruction and conditioning in people with Atopic Dermatitis, run by Margitta Worm at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.