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Enrolling by invitationNCT07603193REACHEDUpdated May 22, 2026

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

An observational study in Chronic Hand Eczema (CHE), sponsored by LEO Pharma. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by LEO Pharma · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Chronic Hand Eczema (CHE)

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Keywords

  • RWE - CHE prospective cohort study......
03

In context

Eczema

503 studies on the registry are indexed under Eczema; 89 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 300 across 81 observational studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 24 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

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

    No interventions

06

What researchers measure

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).

    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

  1. 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).

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

    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).

07

Study locations

1 site
  • LEO Pharma
    Neu-Isenburg, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07603193
Lead sponsor
LEO Pharma
Collaborators
Optimapharm, ICON Clinical Research, IQVIA Inc., Vivactis M2Research
Responsible party
Sponsor
First posted
May 22, 2026
Start date
Jun 1, 2025
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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