Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a pill tame stubborn hand eczema?

NCT ID NCT05682859

Disease control Sponsor: Jacob Pontoppidan Thyssen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether an oral medication called roflumilast can reduce the severity of chronic hand eczema in adults. Participants with moderate to severe hand eczema will receive either roflumilast or a placebo for 16 weeks, followed by a period where everyone gets the active drug. The main goal is to see if at least 75% improvement in eczema severity is achieved.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
roflumilast (an oral PDE4 inhibitor)
What this could lead to
If effective, roflumilast could offer a new oral treatment option for people with chronic hand eczema that doesn't respond to topical therapies.
What could go wrong
This is a small, phase 4 trial, so results may not apply broadly. Roflumilast can cause side effects like nausea, diarrhea, and weight loss.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

41 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Age ≤ 75 years * HECSI ≥ 18 (moderate to severe hand eczema) * IGA-CHE ≥ 3 * Body mass index (BMI) ≥ 20 kg/m2 * Negative pregnancy test (only women of child-bearing potential (see section 2.8)) * Willing to use safe anticonception during entire study and at least 1 week after end of treatment (-5 times plasma half-life of Roflumilast). This only account for women child-bearing potential * Speaks, understands, and reads danish. Exclusion Criteria: * Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis * Diagnosis of current tuberculosis * Current viral hepatitis * History of heart failure (NYHA III-IV) * History of moderate or severe liver failure (Child-Pugh B-C) * Current or former depression with suicidal ideation * Topical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomization * Topical therapy (anti-inflammatory) for chronic hand eczema during study * Systemic therapy for chronic hand eczema 28 days before randomization * Systemic therapy for chronic hand eczema during study * Current treatment with oral dicloxacillin or macrolide * Current treatment with topical antibiotics * Diagnosis of contact eczema of clinical significance 3 months before randomization * Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®) * Confirmed pregnancy * Breast feeding * Blood donation during study * Allergy to roflumilast or any other PDE-4 inhibitor

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic hand eczema are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hand eczema

Contacts and locations

Locations

  • Department of dermatology and veneorology, Bispebjerg Hospital

    Copenhagen, 2400, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.