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Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

NCT05682859 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-18

No results posted yet for this study

Summary

This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension.

The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE).

Patients will receive 16-week treatment with either roflumilast or placebo tablets. Hereafter, both groups continue in open-label treatment for 12 weeks where both groups will receive treatment with roflumilast.

Conditions

  • Chronic Hand Eczema

Interventions

DRUG

Roflumilast 500 Mcg Oral Tablet

Randomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2.

DRUG

Placebo

Placebo tablets

Sponsors & Collaborators

  • The Novo Nordic Foundation

    collaborator OTHER

  • Jacob Pontoppidan Thyssen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2025-04-01
Completion
2026-04-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT05682859 on ClinicalTrials.gov