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OpenTrials
Enrolling by Invitation

NCT Number: NCT07603193

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

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.

Enrolling by Invitation

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Key information

Conditions

Chronic Hand Eczema (CHE)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LEO Pharma

Neu-Isenburg, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

    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 outcomes

  1. Safety and tolerability of delgocitinib cream treatment

    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).

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

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

    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).

    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).

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • ICON Clinical Research
  • IQVIA Inc.
  • Optimapharm
  • Vivactis M2Research

Registry information

Official study title

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)

Acronym: REACHED

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.