Chronic Hand EczemaPhase 3DELTA FORCENCT05259722

A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

A Phase 3 study testing Delgocitinib and Toctino in people with Chronic Hand Eczema, run by LEO Pharma at 102 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hand Eczema
What is being tested?: Delgocitinib and Toctino
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 513 participants
Where: 102 sitesin 10 countries
Study dates: 15 Jun 2022to 5 Dec 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Main inclusion criteria:

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 severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 4).
Participants who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
Participants must use contraceptive methods in accordance with local regulations regarding the methods of contraception for those participating in clinical studies

Main exclusion criteria:

Concurrent skin diseases on the hands, e.g. tinea manuum.
Active atopic dermatitis 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 on the hands.
Participants who cannot receive alitretinoin.
Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial.
History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
Any disorder which is not stable and could:
Affect the safety of the participant throughout the trial.
Impede the participant's ability to complete the trial.
Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.
Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline.
Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline.
Previous or current treatment with Janus kinase (JAK) inhibitors (including delgocitinib/LEO 124249), systemic or topical.
Cutaneously applied treatment with immunomodulators 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 transdermal or 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.
Treatment with any marketed biological therapy or investigational biologic agents:
Any cell-depleting agents: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
Previously used alitretinoin or participated in a clinical trial with alitretinoin or delgocitinib.

Trial locations and contacts

102 sites in 10 countries.

Country

City, postcode or hospital

102 sites in 10 countries

Germany27 sites

LEO Pharma Investigational Site
Augsburg, 86163
LEO Pharma Investigational Site
Berlin, 10789
LEO Pharma Investigational Site
Berlin, 13055
LEO Pharma Investigational Site
Bochum, 44791
LEO Pharma Investigational Site
Bochum, 44793
LEO Pharma Investigational Site
Bonn, 53111
LEO Pharma Investigational Site
Darmstadt, 64283
LEO Pharma Investigational Site
Dresden, 01307
LEO Pharma Investigational Site
Erlangen, 91054
LEO Pharma Investigational Site
Essen, 45147
LEO Pharma Investigational Site
Frankfurt, 60590
LEO Pharma Investigational Site
Friedrichshafen, 88045
LEO Pharma Investigational Site
Gera, 07548
LEO Pharma Investigational Site
Göttingen, 37075
LEO Pharma Investigational Site
Halle, 06110
LEO Pharma Investigational Site
Hamburg, 22391
LEO Pharma Investigational Site
Heidelberg, 69120
LEO Pharma Investigational Site
Langenau, 89129
LEO Pharma Investigational Site
Löhne, 49393
LEO Pharma Investigational Site
Mainz, 55131
LEO Pharma Investigational Site
Marburg, 35043
LEO Pharma Investigational Site
Memmingen, 87700
LEO Pharma Investigational Site
München, 80337
LEO Pharma Investigational Site
München, 80802
LEO Pharma Investigational Site
Oldenburg, 26133
LEO Pharma Investigational Site
Osnabrück, 49074
LEO Pharma Investigational Site
Wuppertal, 42287

Other trials in Germany

Poland18 sites

LEO Pharma Investigational Site
Bialystok, 15-794
LEO Pharma investigational site
Bydgoszcz, 85-796
LEO Pharma Investigational Site
Chorzów, 41-500
LEO Pharma Investigational Site
Gdansk, 80-546
LEO Pharma Investigational Site
Gdynia, 81-338
LEO Pharma Investigational Site
Katowice, 40-081
LEO Pharma investigational site
Katowice, 40-611
LEO Pharma investigational site
Katowice, 40-851
LEO Pharma Investigational Site
Krakow, 30-033
LEO Pharma Investigational Site
Krakow, 30-727
LEO Pharma Investigational Site
Krakow, 31-501
LEO Pharma Investigational Site
Lodz, 90-436
LEO Pharma Investigational Site
Lublin, 20-080
LEO Pharma Investigational Site
Poznan, 61-731
LEO Pharma Investigational Site
Strzelce Opolskie, 47-100
LEO Pharma Investigational Site
Szczecin, 71-434
LEO Pharma Investigational Site
Warsaw, 02-677
LEO Pharma Investigational Site
Wroclaw, 51-685

Other trials in Poland

Spain17 sites

LEO Pharma Investigational Site
Alcalá de Henares, 28805
LEO Pharma Investigational Site
Alicante, 03010
LEO Pharma Investigational Site
Badalona, 08916
LEO Pharma Investigational Site
Barcelona, 08003
LEO Pharma Investigational Site
Barcelona, 08025
LEO Pharma Investigational Site
Córdoba, 14004
LEO Pharma Investigational Site
L'Hospitalet de Llobregat, 08907
LEO Pharma Investigational Site
Madrid, 28006
LEO Pharma Investigational Site
Madrid, 28034
LEO Pharma Investigational Site
Madrid, 28040
LEO Pharma Investigational Site
Madrid, 28041
LEO Pharma investigational site
Málaga, 29009
LEO Pharma investigational site
Pontevedra, 36071
LEO Pharma Investigational Site
Seville, 41009
LEO Pharma Investigational Site
Valencia, 46014
LEO Pharma Investigational Site
Valencia, 46026
LEO Pharma Investigational Site
Zaragoza, 50009

Other trials in Spain

Canada13 sites

LEO Pharma Investigational Site
Calgary, T2J 7E1
LEO Pharma Investigational Site
Calgary, T2W 4X9
LEO Pharma Investigational Site
Edmonton, T6G 1C3
LEO Pharma Investigational Site
Edmonton, T6W0J5
LEO Pharma Investigational Site
Guelph, N1L 0B7
LEO Pharma Investigational Site
London, N6A 2C2
LEO Pharma investigational site
London, N6A 5R9
LEO Pharma investigational site
Markham, L3P 1X3
LEO Pharma investigational site
Niagara Falls, L2H 1H5
LEO Pharma Investigational Site
North York, M2N 3A6
LEO Pharma investigational site
Québec, G1W 4R4
LEO Pharma Investigational Site
Red Deer, T4P 1K4
LEO Pharma investigational site
Sherbrooke, J1G 1X9

Other trials in Canada

Italy10 sites

LEO Pharma Investigational Site
Bologna, 40138
LEO Pharma Investigational Site
Brescia, 25123
LEO Pharma Investigational Site
Catania, 95123
LEO Pharma Investigational Site
Catanzaro, 88100
LEO Pharma Investigational Site
Genova, 16132
LEO Pharma Investigational Site
Lucca, 55100
LEO Pharma Investigational Site
Milan, 20089
LEO Pharma Investigational Site
Pavia, 27100
LEO Pharma Investigational Site
Pisa, 56126
LEO Pharma Investigational Site
Terracina, 4019

Other trials in Italy

France7 sites

LEO Pharma Investigational Site
Antony, 92160
LEO Pharma Investigational Site
Martigues, 13500
LEO Pharma Investigational Site
Montpellier, 34295
LEO Pharma Investigational Site
Nice, 06000
LEO Pharma investigational site
Nice, 6202
LEO Pharma Investigational Site
Reims, 51100
LEO Pharma Investigational Site
Toulon, 83000

Other trials in France

Austria3 sites

LEO Pharma Investigational Site
Graz, 8036
LEO Pharma Investigational Site
Linz, 4010
LEO Pharma Investigational Site
Linz, 4021

Other trials in Austria

Slovakia3 sites

LEO Pharma Investigational Site
Bratislava, 851 01
LEO Pharma Investigational Site
Svidník, 089 01
LEO Pharma Investigational Site
Trnava, 917 75

Other trials in Slovakia

Norway2 sites

LEO Pharma Investigational Site
Stavanger, 4011
LEO Pharma Investigational Site
Tromsø, 9038

Other trials in Norway

United Kingdom2 sites

LEO Pharma Investigational Site
London, SE1 9RT
LEO Pharma Investigational Site
Nottingham, NG7 2UH

Other trials in United Kingdom

About this study

Official title: A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.

The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

Conditions: Chronic Hand Eczema
Being tested: Delgocitinib, Toctino

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DelgocitinibDrug
Cream for topical application 20 mg/g
ToctinoDrug
1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur

Study groups in NCT05259722
Study group	Role	What they receive
Delgocitinib cream 20 mg/g	Experimental	Twice-daily topical application for up to 24 weeks Receives: Drug: Delgocitinib
Alitretinoin capsules 30 mg per capsule	Active comparator	1 capsule per day for up to 24 weeks Receives: Drug: Toctino

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HECSI Score From Baseline to Week 12
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity.
Measured: 12 weeks

Secondary outcomes (10)

HECSI-90 at Week 12
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
Measured: 12 weeks
IGA-CHE TS at Week 12.
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
Measured: 12 weeks
Change in HESD Itch Score (Weekly Average) From Baseline to Week 12
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'itch' component.
Measured: 12 weeks
Change in HESD Pain Score (Weekly Average) From Baseline to Week 12.
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'pain' component.
Measured: 12 weeks
AUC of HECSI-90 From Baseline up to Week 24
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline. The area under the curve (AUC) at participant level will be determined as follows: 1 will be assigned when response is observed and 0 otherwise. The AUC is interpreted as number of days with 90% reduction in HECSI score until Week 24.
Measured: 24 weeks
AUC of Change From Baseline in DLQI Score up to Week 24
The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life. The area under the curve (AUC) at patient level will be determined from the change from baseline in DLQI score estimated as a piecewise linear function from Week 0 to Week 24. Differences will be analyzed with opposite sign to interpret positive area as improvement in scores and negative area as worsening.
Measured: 24 weeks
Change in HECSI Score From Baseline to Week 24
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity.
Measured: 24 weeks
Number of Treatment-emergent AEs From Baseline up to Week 26
An adverse event (AE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP.
Measured: 26 weeks
Number of Treatment-emergent SAEs From Baseline up to Week 26
A serious adverse event (SAE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP.
Measured: 26 weeks
Number of AEs Leading to IMP Discontinuation up to Week 24
The investigational medicinal product (IMP) will be discontinued permanently in case of an AE that, in the opinion of the investigator or sponsor's medical expert, contraindicates further dosing. The investigator will assess the relationship between investigational medicinal product (IMP) and the adverse event (AE).
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20225 Dec 2023

First posted28 Feb 2022
Study start15 Jun 2022
Primary completion8 Nov 2023
Study completion5 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Hand EczemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 513 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05259722
Sponsor's protocol ID: LP0133-1528
Other IDs: 2021-003543-16, U1111-1284-2242
Acronym: DELTA FORCE
Status last verified: Feb 2025
First submitted: 18 Feb 2022
Last updated: 9 May 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gimenez-Arnau AM, Pinter A, Sondermann W, Reguiai Z, Woolf R, Lynde C, Legat FJ, Costanzo A, Silvestre JF, Mellerup N, Osterdal ML, Plohberger U, Ryttig L, Bauer A; trial investigators. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial. Lancet. 2025 May 10;405(10490):1676-1688. doi: 10.1016/S0140-6736(25)00001-7. Epub 2025 Apr 16.
PubMed 40252681

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingObservational study
PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry
Chronic Hand Eczema
Enrolling by invitationObservational study
Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream
Chronic Hand Eczema (CHE)
RecruitingObservational study
Characterization of Chronic Hand Eczema
Chronic Hand Eczema, Atopic Dermatitis
Recruiting
Immune Signature of Chronic Hand Eczema Unveiled by Spatial Transcriptomics and Single-Cell Proteomics
Hand Eczema

All Chronic Hand Eczema trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema
ClinicalTrials.gov ID: NCT05259722
Acronym / sponsor ID: DELTA FORCE / LP0133-1528
Conditions: Chronic Hand Eczema
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 513 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: 15 Jun 2022 (actual)
Primary completion: 8 Nov 2023 (actual)
Study completion: 5 Dec 2023 (actual)
First posted: 28 Feb 2022 (actual)
Results: Posted 14 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Delgocitinib cream 20 mg/g	Experimental	Drug: DelgocitinibTwice-daily topical application for up to 24 weeks
Alitretinoin capsules 30 mg per capsule	Active comparator	Drug: Toctino1 capsule per day for up to 24 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DelgocitinibCream for topical application 20 mg/g	Drug	Delgocitinib cream 20 mg/g
Toctino1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur	Drug	Alitretinoin capsules 30 mg per capsule

Primary outcome

Change in HECSI Score From Baseline to Week 12
Time frame: 12 weeks
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity.

10 secondary outcomes

HECSI-90 at Week 12
Time frame: 12 weeks
IGA-CHE TS at Week 12.
Time frame: 12 weeks
Change in HESD Itch Score (Weekly Average) From Baseline to Week 12
Time frame: 12 weeks
Change in HESD Pain Score (Weekly Average) From Baseline to Week 12.
Time frame: 12 weeks
AUC of HECSI-90 From Baseline up to Week 24
Time frame: 24 weeks
AUC of Change From Baseline in DLQI Score up to Week 24
Time frame: 24 weeks
Change in HECSI Score From Baseline to Week 24
Time frame: 24 weeks
Number of Treatment-emergent AEs From Baseline up to Week 26
Time frame: 26 weeks
Number of Treatment-emergent SAEs From Baseline up to Week 26
Time frame: 26 weeks
Number of AEs Leading to IMP Discontinuation up to Week 24
Time frame: 24 weeks

Results and safety

Results posted to the registry on 14 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delgocitinib Cream 20 mg/g	254	219
Alitretinoin Capsules 30 mg Per Capsule	259	154

Primary outcome: Change in HECSI Score From Baseline to Week 12

Time frame: 12 weeks. Mean (Standard Error). Unit: score on a scale

Measure	Delgocitinib Cream 20 mg/g n = 249	Alitretinoin Capsules 30 mg Per Capsule n = 250
Value	-67.6 (3.37)	-51.5 (3.36)

Delgocitinib Cream 20 mg/g vs Alitretinoin Capsules 30 mg Per Capsule: Mean Difference (Net): -16.1 (95% CI -23.28 to -8.86), p <0.001, ANCOVA

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to Week 26. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delgocitinib Cream 20 mg/g	5 of 253 (2%)	58 of 253 (22.9%)	0 of 253
Alitretinoin Capsules 30 mg Per Capsule	12 of 247 (4.9%)	143 of 247 (57.9%)	0 of 247

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40252681Gimenez-Arnau AM, Pinter A, Sondermann W, Reguiai Z, Woolf R, Lynde C, Legat FJ, Costanzo A, Silvestre JF, Mellerup N, Osterdal ML, Plohberger U, Ryttig L, Bauer A; trial investigators. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial. Lancet. 2025 May 10;405(10490):1676-1688. doi: 10.1016/S0140-6736(25)00001-7. Epub 2025 Apr 16.
Individual participant dataSharing planned: No

Related trials for Chronic Hand Eczema

RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingObservational study
PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry
Chronic Hand Eczema
Enrolling by invitationObservational study
Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream
Chronic Hand Eczema (CHE)
RecruitingObservational study
Characterization of Chronic Hand Eczema
Chronic Hand Eczema, Atopic Dermatitis
Recruiting
Immune Signature of Chronic Hand Eczema Unveiled by Spatial Transcriptomics and Single-Cell Proteomics
Hand Eczema

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Expert study director

LEO Pharma

102 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Delgocitinib and Toctino in people with Chronic Hand Eczema, run by LEO Pharma at 102 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in Germany, Poland, Spain, Canada, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HECSI Score From Baseline to Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05259722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.