Recruiting

Delgocitinib Cream

Sponsor:

LEO Pharma

Code:

NCT07603193

Conditions

Chronic Hand Eczema (CHE)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT07603193

Start date

Jun 1, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

No interventions

Primary outcome measure

  • modified Physician Global Assessment (mPGA) [ 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). ]

Central Contacts and Locations

Locations

Baptist Medical Center East

Recruiting

Montgomery, Alabama, United States, 36117

More Information

Sponsor

LEO Pharma

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by LEO Pharma on 2026-05-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.