Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

Sponsor
Jacob Pontoppidan Thyssen
Study ID
NCT05682859
Phase
PHASE4
Status
Unknown

Conditions

  • Chronic Hand Eczema

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast 500 Mcg Oral Tablet — DRUG
    Randomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2.
  • Placebo — DRUG
    Placebo tablets

Study Details

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.

Key Dates

Start date
Sep 25, 2023
Status verified
Nov 2023
Primary completion
Apr 1, 2025
Completion
Apr 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast
    20 of the participating patients are randomized to the active arm where systemic roflumilast 500 microgram tablets are received.
  • Placebo Comparator: Placebo
    20 of the participating patients are randomized to the active arm where systemic placebo tablets are received.

Primary Outcome Measure

Proportion of patients achieving at least 75% reduction in hand eczema severity index (HECSI75) at week 16 when compared to HECSI at baseline. [ Time Frame: Through study completion, an average of 28 weeks ]

Central Contacts