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Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema

NCT03683719 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2025-03-12

Study results available
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Summary

The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.

Conditions

  • Chronic Hand Eczema

Interventions

DRUG

Delgocitinib cream

Cream for topical application.

DRUG

Delgocitinib cream vehicle

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Medical Expert · LEO Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2020-03-06
Completion
2020-04-20
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683719 on ClinicalTrials.gov