Trials
Search / Trial NCT06427122

Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life

Launched by TAMAR NIJSTEN · May 21, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

Emd Protocol For Urge Quality Of Life Itch Scratching

ClinConnect Summary

This clinical trial is studying the impact of a new treatment called EMD-U on the quality of life for patients suffering from atopic dermatitis or prurigo nodularis, especially those who experience severe scratching. The goal is to see if adding EMD-U to standard care (CAU) can help improve patients' lives more than just standard care alone. Participants will be assessed at several points—after 4 weeks, 8 weeks, 12 weeks, and 6 months—to measure changes in their symptoms and quality of life.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of atopic dermatitis or prurigo nodularis, and struggle with frequent scratching. They should also have a specific level of disease activity and must not have changed their treatment in the two weeks before joining the study. Participants will be randomly assigned to either receive the EMD-U treatment or continue with standard care. It’s important to note that anyone who changes their medication during the study will be dropped from the trial. This study is currently recruiting participants of all genders, and it is conducted in Dutch, so a good understanding of the language is necessary to participate.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • Insufficient understanding of Dutch language
  • Severe psychiatric disorders that require treatment first, such as delusional disorder or major depression
  • 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.

Trial Officials

Rick Waalboer-Spuij, MD, PhD

Principal Investigator

Erasmus University Medical Center, Department of Dermatology

Leonieke W Kranenburg, PhD

Principal Investigator

Erasmus University Medical Center, Department of Psychiatry, Section Medical Psychology

About Tamar Nijsten

Tamar Nijsten is a dedicated clinical trial sponsor known for its commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic areas, Tamar Nijsten collaborates with leading healthcare professionals and research institutions to design and conduct rigorous clinical trials. The organization prioritizes patient safety and ethical standards while striving for scientific excellence. By leveraging cutting-edge methodologies and a patient-centered approach, Tamar Nijsten aims to contribute meaningful insights to the medical community and enhance the efficacy of treatments available to patients worldwide.

Locations

Rotterdam, , Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0