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

NCT07603193 | Enrolling By Invitation

• 1 other identifier: NIS-Delgo-2448
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hand Eczema (CHE)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (2)

• 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).

• 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).

Study Arms (1)

Adult patients with moderate to severe CHE treated with delgocitinib cream as routine clinical care

No interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from hospitals or dermatology clinics (private or public)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead
• Optimapharm: collaborator
• ICON Clinical Research: collaborator
• IQVIA Inc.: collaborator
• Vivactis M2Research: collaborator

Study Sites (1)

LEO Pharma

Neu-Isenburg, Germany

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 22, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

DE (1)