Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream

Prospective, Non-interventional, Multicenter Real-world Evidence Study on Effectiveness and Safety of Treatment of Patients With Moderate to Severe Chronic Hand Eczema With Delgocitinib Cream (20mg/g)

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07603193

Acronym

REACHED

Enrollment

1000

Registered

2026-05-22

Start date

2025-06-01

Completion date

2030-12-31

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hand Eczema (CHE)

Keywords

RWE - CHE prospective cohort study......

Brief summary

The goal of this non-interventional study is to assess changes in the signs and symptoms of Chronic Hand Eczema (CHE), as well as the safety profile and use of delgocitinib cream in routine clinical practice, over a 52-week observation period. The main question it aims to answer is: Does delgocitinib cream show effectiveness in routine clinical practice in adult patients with moderate to severe Chronic Hand Eczema (CHE), as measured by achievement of a modified Physician Global Assessment (mPGA) score of 0 or 1? The decision to prescribe delgocitinib cream is made by the treating physician, as part of the participant's routine medical care for CHE.

Detailed description

Expected countries to participate includes, but not limited, to Germany, US, Canada, UK, Italy and Spain

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Written informed consent to participate in this study and for collecting and analysing medical data pertinent to the study objectives. * Age ≥18 years * Patients diagnosed with CHE who are eligible for treatment with delgocitinib cream as per the physician's clinical discretion.

Exclusion criteria

* Currently enrolled in an interventional clinical trial, or have participated in an interventional clinical trial in the past year from the date of enrolment * Previous enrolment in this non-interventional study. * Previous treatment with delgocitinib cream.

Design outcomes

Primary

Measure	Time frame	Description
modified Physician Global Assessment (mPGA)	The mPGA will be assessed at baseline, at each study visit during the study in accordance with routine clinical practice (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).	The modified physician global assessment (mPGA) scale will be used to assess the CHE severity and progression before and after the topical treatment with delgocitinib. The mPGA scale will be used by the treating physicians to rate the severity of CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Secondary

Measure	Time frame	Description
Safety and tolerability of delgocitinib cream treatment	The safety and tolerability of delgocititinib will be assessed at baseline, at each study visit during the study (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).	Assess adverse drug reactions and serious adverse events during the conduct of the study.
Short-term and long-term effectiveness of treatment with delgocitinib cream	The mPGA will be assessed at baseline, at each study visit during the study in accordance with routine clinical practice (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).	The modified physician global assessment (mPGA) scale will be used to assess the CHE severity and progression before and after the topical treatment with delgocitinib. The mPGA scale will be used by the treating physicians to rate the severity of CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Countries

Germany

Outcome results