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

N/AEnrolling By InvitationNCT07603193

LEO Pharma1,000 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Chronic Hand Eczema (CHE)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

modified Physician Global Assessment (mPGA)

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).

Time frame: 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).

Secondary Outcomes

Safety and tolerability of delgocitinib cream treatment

Assess adverse drug reactions and serious adverse events during the conduct of the study.

Time frame: 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).

Short-term and long-term effectiveness of treatment with delgocitinib cream