CompletedNot Applicable

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

Netherlands96 participantsStarted 2024-03-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Skindex-29

Timeframe: measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4).

Trial details

NCT IDNCT06427122

SponsorTamar Nijsten

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-15