NCT06427122Completed
Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life
The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
The primary objective of this open randomised controlled trial is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour. The main study parameter is the difference in treatment effect between EMD-U and CAU at T2, measured with the Skindex-29 symptoms scale. There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months. Patients are randomly allocated to either the EMD-U or CAU condition.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 7 Feb 2024
- Start date
- 11 Mar 2024
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- Tamar Nijsten
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06427122
What you commit to
- Study type: Interventional
- Participants enrolled: 96
- From 11 Mar 2024 to the primary completion date, 15 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- If medication is changed during the course of the study, the participant will be considered a drop-out from the moment the medication has changed.
Other illness
- Severe psychiatric disorders that require treatment first, such as delusional disorder or major depression
Other
- Insufficient understanding of Dutch language
Who the study is looking for
- Age 18 ≥
- A confirmed diagnosis of atopic dermatitis or prurigo nodularis
- Suffering from persistent and frequent scratching behaviour
- IGA-CPG activity score ≥ 3 OR Skindex-29 symptoms subscale score ≥ 42
- Stable course of treatment in the two weeks prior to the study (no medication change, etc.)
- Sufficiently motivated to take part in a new intervention aimed at behaviour change
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.