CompletedPhase 1

Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema

Germany15 participantsStarted 2022-09-06

Plain-language summary

The purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema. Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. Everyone in the trial will use delgocitinib cream. The trial will last up to 7 weeks and there will be 6 visits and a phone call. There will be a screening period of up to 4 weeks, a treatment period (with blood sampling) of 11 days and a safety follow-up phone call 11 days after the last visit.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or above at screening. * Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months. * Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4). * Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks). * Subjects adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens. Exclusion Criteria: * Concurrent skin diseases on the hands, e.g. tinea manuum. * Active atopic dermatitis (AD) requiring medical treatment in regions other than the hands and feet. * Active psoriasis on any part of the body. * Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body. * Clinically significant infection (e.g. impetiginised hand eczema) on the hands. * Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the concentration-time curve 0-12 hours post dose at Day 1 and Day 8 (AUC0-12).

Timeframe: 0-12 hours post dose at Day 1 and Day 8

Maximum observed concentration (Cmax) at Day 1 and at Day 8 (0-12 hours post-dose).

Timeframe: Day 1 and at Day 8 (0-12 hours post-dose)

Trial details

NCT IDNCT05486117

SponsorLEO Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-22

View on ClinicalTrials.gov More Chronic Hand Eczema trials