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New cream could soothe stubborn hand eczema in teens

NCT ID NCT05355818

Disease control Sponsor: LEO Pharma 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tested a cream called delgocitinib in 98 teens aged 12-17 with moderate to severe chronic hand eczema. Participants applied the cream or a placebo twice daily for 16 weeks. Doctors checked how well the cream cleared eczema and tracked side effects. The goal is to see if this cream offers a new option for teens who haven't gotten relief from standard treatments.

What this could mean

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

Active substance
delgocitinib cream
What this could lead to
If successful, this could provide a new treatment option for teens with chronic hand eczema that hasn't responded well to standard steroid creams.
What could go wrong
This is a Phase 3 trial, but results are not yet published. The cream may not work better than the placebo, and side effects are still being studied.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

98 people

The number who actually took part.

Started

Jul 2022

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 to 17 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 12 to 17 years at screening and baseline. * 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). * Inadequate response is defined as a history of failure to achieve and maintain a low disease activity state (comparable to an IGA-CHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent) for Europe and Australia and class IV-I (medium potency to very/ultra-high potency) for Canada, applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter. * Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, and significant skin atrophy as assessed by the physician. Exclusion Criteria: * Concurrent skin diseases on the hands, e.g. tinea manuum. * 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 rhinitis are allowed). * Use of tanning beds, phototherapy (e.g. ultraviolet B (UVB), ultraviolet A1 (UVA1), psoralen ultraviolet A (PUVA)), or bleach baths on the hands within 28 days prior to baseline. * Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249), systemic or topical. * Cutaneously applied treatment with immunomodulators (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline. * Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline. * Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline. * Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline. * Any disorder which is not stable and could: * Affect the safety of the subject throughout the trial. * Impede the subject's ability to complete the trial. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, and major physical impairment.

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As listed by the trial registrant

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

Chronic hand eczema

Contacts and locations

Locations

  • LEO Pharma investigational site

    Darlinghurst, 2010, Australia

  • LEO Pharma investigational site

    Mitcham, 3132, Australia

  • LEO Pharma investigational site

    Phillip, 2606, Australia

  • LEO Pharma investigational site

    Woolloongabba, 4102, Australia

  • LEO Pharma investigational site

    Brussels, 1200, Belgium

  • LEO Pharma investigational site

    Ghent, 9000, Belgium

  • LEO Pharma investigational site

    Gilly, 6060, Belgium

  • LEO Pharma investigational site

    Liège, 4000, Belgium

  • LEO Pharma investigational site

    Edmonton, T6G 1C3, Canada

  • LEO Pharma investigational site

    Fredericton, E3B 1G9, Canada

  • LEO Pharma investigational site

    Kingston, K7L 2V7, Canada

  • LEO Pharma investigational site

    Montreal, H3T 1C5, Canada

  • LEO Pharma investigational site

    Red Deer, T4P1K4, Canada

  • LEO Pharma investigational site

    St. John's, NL A1E 1V4, Canada

  • LEO Pharma investigational site

    Toronto, M2N 3A6, Canada

  • LEO Pharma investigational site

    Winnipeg, R3C 0N2, Canada

  • LEO Pharma investigational site

    Martigues, Bouches-du-Rhône, 13500, France

  • LEO Pharma investigational site

    Nice, 06000, France

  • LEO Pharma investigational site

    Reims, 51100, France

  • LEO Pharma investigational site

    Toulouse, 31059, France

  • LEO Pharma investigational site

    Chorzów, 41-516, Poland

  • LEO Pharma investigational site

    Krakow, 30-002, Poland

  • LEO Pharma investigational site

    Krakow, 30-033, Poland

  • LEO Pharma investigational site

    Krakow, 31-011, Poland

  • LEO Pharma investigational site

    Warsaw, 02-625, Poland

  • LEO Pharma investigational site

    Wroclaw, 51-503, Poland

  • LEO Pharma investigational site

    Alicante, 03010, Spain

  • LEO Pharma investigational site

    Barcelona, 08041, Spain

  • LEO Pharma investigational site

    Cadiz, 11009, Spain

  • LEO Pharma investigational site

    Esplugues de Llobregat, 08950, Spain

  • LEO Pharma investigational site

    Fuenlabrada, 28942, Spain

  • LEO Pharma investigational site

    Granada, 18016, Spain

  • LEO Pharma investigational site

    Ipswich, IP4 5PD, United Kingdom

  • LEO Pharma investigational site

    Kings Lynn, PE30 4ET, United Kingdom

  • LEO Pharma investigational site

    Lincoln, LN2 5QY, United Kingdom

  • LEO Pharma investigational site

    London, SW10 9NH, United Kingdom

  • LEO Pharma investigational site

    Walsall, WS2 9PS, United Kingdom

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