Chronic Hand EczemaPhase 3DELTA 1NCT04871711

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

A Phase 3 study testing Delgocitinib cream in people with Chronic Hand Eczema, run by LEO Pharma at 54 sites in 6 countries.

Completed

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

Official record

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Trial summary

This was a 16-week study in adult participants with chronic hand eczema (CHE). > The participants visited the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hand Eczema
What is being tested?: Delgocitinib cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 487 participants
Where: 54 sitesin 6 countries
Study dates: 10 May 2021to 31 Oct 2022
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 moderate to severe at screening and baseline according to Investigator's Global Assessment for chronic hand eczema (IGA-CHE) (i.e. an IGA-CHE score of 3 or 4).
Hand Eczema Symptom Diary (HESD) itch score (weekly average) of ≥4 points at baseline.
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.

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.
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.
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.

Trial locations and contacts

54 sites in 6 countries.

Country

City, postcode or hospital

54 sites in 6 countries

France13 sites

LEO Investigational Site
Bordeaux, 33000
LEO Investigational Site
Dijon, 21000
LEO Investigational Site
Le Mans, Sarthe, 72037
LEO Investigational Site
Lille, Nord, 59000
LEO Investigational Site
Lorient, 56322
LEO Investigational Site
Martigues, 13500
LEO Investigational Site
Nantes, Loire-Atlantique 6, 44093
LEO Investigational Site
Nice, Alpes-Maritimes, 06202
LEO Investigational Site
Nice, 06000
LEO Investigational Site
Paris, 75014
LEO Investigational Site
Reims, Ardennes, 51100
LEO Investigational Site
Toulouse, 31000
LEO Investigational Site
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Canada10 sites

LEO Investigational Site
Calgary, Alberta, T2J 7E1
LEO Investigational Site
Calgary, Alberta, T3E 0B2
LEO Investigational Site
Edmonton, Alberta, T5J 3S9
LEO Investigational Site
Edmonton, Alberta, T6G 1C3
LEO Investigational Site
Kingston, Ontario, K7L 2V7
LEO Investigational Site
London, Ontario, N6A 3H7
LEO Investigational Site
Markham, Ontario, L3P 1X3
LEO Investigational Site
Montreal, Quebec, H2X 2V1
LEO Investigational Site
Red Deer, Alberta, T4P-1K4
LEO Investigational Site
Toronto, Ontario, M3H 5Y8

Other trials in Canada

Germany10 sites

LEO Investigational Site
Berlin, 10117
LEO Investigational Site
Dresden, 01307
LEO Investigational Site
Gera, 07548
LEO Investigational Site
Göttingen, 37073
LEO Investigational Site
Hamburg, 22391
LEO Investigational Site
Haßfurt, 97437
LEO Investigational Site
Mainz, 55128
LEO Investigational Site
Memmingen, 87700
LEO Investigational Site
München, 80802
LEO Investigational Site
Osnabrück, 49074

Other trials in Germany

Poland9 sites

LEO Investigational Site
Bialystok, 15-794
LEO Investigational Site
Gdansk, 80-546
LEO Investigational Site
Krakow, 30-033
LEO Investigational Site
Krakow, 31-011
LEO Investigational Site
Lodz, 90-436
LEO Investigational Site
Lublin, 20-081
LEO Investigational Site
Osielsko, 86-031
LEO Investigational Site
Warsaw, 02-507
LEO Investigational Site
Warsaw, 02-953

Other trials in Poland

Italy6 sites

LEO Investigational Site
Brescia, 25123
LEO Investigational Site
L’Aquila, 67100
LEO Investigational Site
Milan, 20122
LEO Investigational Site
Perugia, 06134
LEO Investigational Site
Roma, 00168
LEO Investigational Site
Vicenza, 36100

Other trials in Italy

United Kingdom6 sites

LEO Investigational Site
Leicester, Leicestershire, LE1 5WW
LEO Investigational Site
London, Leytonstone, E11 1NR
LEO Investigational Site
London, SE1 9RT
LEO Investigational Site
Middlesbrough, North Yorkshire, TS4 3BW
LEO Investigational Site
Redhill, Surrey, RH1 5RH
LEO Investigational Site
Salford, Greater Manchester, M6 8HD

Other trials in United Kingdom

About this study

Official title: A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)

> The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

Conditions: Chronic Hand Eczema
Being tested: Delgocitinib cream, Cream vehicle

What participants receive

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

Delgocitinib creamDrug
Also called LEO 124249 cream
Cream for topical application
Cream vehicleDrug
The cream vehicle is similar to the delgocitinib cream> except that it does not contain any active ingredient.

Study groups in NCT04871711
Study group	Role	What they receive
Delgocitinib cream 20 mg/g	Experimental	Twice-daily topical application for 16 weeks Receives: Drug: Delgocitinib cream
Cream vehicle	Placebo comparator	Twice-daily topical application for 16 weeks Receives: Drug: Cream vehicle

What is being measured

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

Number of Participants With IGA-CHE TS at Week 16
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: 16 weeks

Secondary outcomes (24)

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16
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 and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Measured: 16 weeks
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16
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. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
Measured: 16 weeks
Number of Participants With IGA-CHE TS at Week 8
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 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: 8 weeks
Number of Participants With IGA-CHE TS at Week 4
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 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: 4 weeks
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8
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 and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Measured: 8 weeks
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4
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 and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Measured: 4 weeks
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2
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 and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Measured: 2 weeks
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8
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. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
Measured: 8 weeks
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4
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. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
Measured: 4 weeks
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16
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 and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
Measured: 16 weeks
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8
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 and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
Measured: 8 weeks
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4
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 and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
Measured: 4 weeks
Number of Participants With HECSI-90 at Week 16
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: 16 weeks
Number of Participants With HECSI-75 at Week 16
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-75 is defined as at least 75% improvement in HECSI score from baseline.
Measured: 16 weeks
Number of Participants With HECSI-75 at Week 8
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-75 is defined as at least 75% improvement in HECSI score from baseline.
Measured: 8 weeks
Percentage Change in HECSI Score From Baseline to Week 16
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: 16 weeks
Change in DLQI Score From Baseline to Week 16
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.
Measured: 16 weeks
Change in HESD Score (Weekly Average) From Baseline to Week 16
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. The HESD score is derived as the average of the 6 signs and symptoms.
Measured: 16 weeks
Change in HESD Itch Score (Weekly Average) From Baseline to Week 16
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: 16 weeks
Change in HESD Pain Score (Weekly Average) From Baseline to Week 16
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: 16 weeks
Change in HEIS Score From Baseline to Week 16
The Hand Eczema Impact Scale (HEIS) addresses 9 items within the following domains: Proximal Daily Activity Limitations (PDAL), embarrassment with the appearance of the hands, frustration with CHE, sleep, work, and physical functioning. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The HEIS score is the average of the 9 items.
Measured: 16 weeks
Change in HEIS PDAL Score From Baseline to Week 16
Proximal Daily Activity Limitations (PDAL) is one of the domain scores in Hand Eczema Impact Scale (HEIS) assessing the participant's perceived impact on their daily activities. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). HEIS PDAL score is the average of the 3 items.
Measured: 16 weeks
Reduction of DLQI Score of ≥4 Points From Baseline at Week 16
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. This endpoint will be evaluated among participants with a baseline DLQI score ≥4 points.
Measured: 16 weeks
Number of Treatment-emergent AEs From Baseline up to End of Trial
An adverse event (AE) were 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. End of trial was defined as Week 16 for participants who rolled over to the long-term extension trial and as Week 18 for participants who did not roll over.
Measured: 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])

Timeline

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

10 May 202131 Oct 2022

First posted4 May 2021
Study start10 May 2021
Primary completion31 Oct 2022
Study completion31 Oct 2022

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 (5)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 487 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04871711
Sponsor's protocol ID: LP0133-1401
Other IDs: 2020-002960-30, U1111-1284-2099
Acronym: DELTA 1
Status last verified: May 2024
First submitted: 29 Apr 2021
Last updated: 8 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bissonnette R, Warren RB, Pinter A, Agner T, Gooderham M, Schuttelaar MLA, Crepy MN, Stingeni L, Serra-Baldrich E, Baranowski K, Korn S, Kurvits M, Plohberger U, Strange Vest N, Schliemann S; trial investigators. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024 Aug 3;404(10451):461-473. doi: 10.1016/S0140-6736(24)01027-4. Epub 2024 Jul 18.
PubMed 39033766
Bauer A, Guenther L, Woolf R, Didriksen Apol E, Maslin D, Nyholm N, Thoning H, Schuttelaar ML. Effect of Delgocitinib Cream on Health-Related Quality of Life in Patients With Moderate to Severe Chronic Hand Eczema. Contact Dermatitis. 2026 Jul;95(1):91-99. doi: 10.1111/cod.70114. Epub 2026 Mar 3.
PubMed 41775339
Cohen D, Bewley A, Wollenberg A, Hong HC, Armstrong A, Jonsen E, Maslin D, Thoning H, von Eyben R, Chovatiya R. Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. Dermatol Ther (Heidelb). 2026 Jan;16(1):423-436. doi: 10.1007/s13555-025-01592-y. Epub 2025 Nov 15.
PubMed 41240207
Silverberg JI, Agner T, Baranowski K, Plohberger U, Thoning H, Arbuckle R, Grant L, Skingley G, Bissonnette R. Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure of CHE severity. Arch Dermatol Res. 2024 Mar 20;316(4):110. doi: 10.1007/s00403-024-02818-3.
PubMed 38507100
Molin S, Larsen LS, Joensson P, Oesterdal ML, Arbuckle R, Grant L, Skingley G, Schuttelaar MLA. Development and Psychometric Validation of a Patient-Reported Outcome Measure to Assess the Signs and Symptoms of Chronic Hand Eczema: The Hand Eczema Symptom Diary (HESD). Dermatol Ther (Heidelb). 2024 Mar;14(3):643-669. doi: 10.1007/s13555-024-01114-2. Epub 2024 Mar 15.
PubMed 38485862

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

All Chronic Hand Eczema trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)
ClinicalTrials.gov ID: NCT04871711
Acronym / sponsor ID: DELTA 1 / LP0133-1401
Conditions: Chronic Hand Eczema
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 487 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: 10 May 2021 (actual)
Primary completion: 31 Oct 2022 (actual)
Study completion: 31 Oct 2022 (actual)
First posted: 4 May 2021 (actual)
Results: Posted 23 Sep 2024

Clinical summary

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

> The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Delgocitinib cream 20 mg/g	Experimental	Drug: Delgocitinib creamTwice-daily topical application for 16 weeks
Cream vehicle	Placebo comparator	Drug: Cream vehicleTwice-daily topical application for 16 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
Delgocitinib creamAlso: LEO 124249 creamCream for topical application	Drug	Delgocitinib cream 20 mg/g
Cream vehicleThe cream vehicle is similar to the delgocitinib cream> except that it does not contain any active ingredient.	Drug	Cream vehicle

Primary outcome

Number of Participants With IGA-CHE TS at Week 16
Time frame: 16 weeks
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.

24 secondary outcomes

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Time frame: 16 weeks
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Time frame: 16 weeks
Number of Participants With IGA-CHE TS at Week 8
Time frame: 8 weeks
Number of Participants With IGA-CHE TS at Week 4
Time frame: 4 weeks
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8
Time frame: 8 weeks
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4
Time frame: 4 weeks
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2
Time frame: 2 weeks
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8
Time frame: 8 weeks
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4
Time frame: 4 weeks
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Time frame: 16 weeks
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8
Time frame: 8 weeks
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4
Time frame: 4 weeks
Number of Participants With HECSI-90 at Week 16
Time frame: 16 weeks
Number of Participants With HECSI-75 at Week 16
Time frame: 16 weeks
Number of Participants With HECSI-75 at Week 8
Time frame: 8 weeks
Percentage Change in HECSI Score From Baseline to Week 16
Time frame: 16 weeks
Change in DLQI Score From Baseline to Week 16
Time frame: 16 weeks
Change in HESD Score (Weekly Average) From Baseline to Week 16
Time frame: 16 weeks
Change in HESD Itch Score (Weekly Average) From Baseline to Week 16
Time frame: 16 weeks
Change in HESD Pain Score (Weekly Average) From Baseline to Week 16
Time frame: 16 weeks
Change in HEIS Score From Baseline to Week 16
Time frame: 16 weeks
Change in HEIS PDAL Score From Baseline to Week 16
Time frame: 16 weeks
Reduction of DLQI Score of ≥4 Points From Baseline at Week 16
Time frame: 16 weeks
Number of Treatment-emergent AEs From Baseline up to End of Trial
Time frame: 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])

Results and safety

Results posted to the registry on 23 Sep 2024, 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	325	305
Cream Vehicle	162	141

Primary outcome: Number of Participants With IGA-CHE TS at Week 16

Time frame: 16 weeks. Count of participants. Unit: Participants

Measure	Delgocitinib Cream 20 mg/g n = 325	Cream Vehicle n = 162
Value	64	16

Delgocitinib Cream 20 mg/g vs Cream Vehicle: Risk Difference (RD): 9.8 (95% CI 3.6 to 16.1), p = 0.006, Cochran-Mantel-Haenszel

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403]). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delgocitinib \|20 mg/g	6 of 325 (1.8%)	69 of 325 (21.2%)	0 of 325
Vehicle\|	3 of 162 (1.9%)	42 of 162 (25.9%)	0 of 162

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39033766Bissonnette R, Warren RB, Pinter A, Agner T, Gooderham M, Schuttelaar MLA, Crepy MN, Stingeni L, Serra-Baldrich E, Baranowski K, Korn S, Kurvits M, Plohberger U, Strange Vest N, Schliemann S; trial investigators. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024 Aug 3;404(10451):461-473. doi: 10.1016/S0140-6736(24)01027-4. Epub 2024 Jul 18.
Derived from this study: PubMed 41775339Bauer A, Guenther L, Woolf R, Didriksen Apol E, Maslin D, Nyholm N, Thoning H, Schuttelaar ML. Effect of Delgocitinib Cream on Health-Related Quality of Life in Patients With Moderate to Severe Chronic Hand Eczema. Contact Dermatitis. 2026 Jul;95(1):91-99. doi: 10.1111/cod.70114. Epub 2026 Mar 3.
Derived from this study: PubMed 41240207Cohen D, Bewley A, Wollenberg A, Hong HC, Armstrong A, Jonsen E, Maslin D, Thoning H, von Eyben R, Chovatiya R. Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. Dermatol Ther (Heidelb). 2026 Jan;16(1):423-436. doi: 10.1007/s13555-025-01592-y. Epub 2025 Nov 15.
Derived from this study: PubMed 38507100Silverberg JI, Agner T, Baranowski K, Plohberger U, Thoning H, Arbuckle R, Grant L, Skingley G, Bissonnette R. Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure of CHE severity. Arch Dermatol Res. 2024 Mar 20;316(4):110. doi: 10.1007/s00403-024-02818-3.
Derived from this study: PubMed 38485862Molin S, Larsen LS, Joensson P, Oesterdal ML, Arbuckle R, Grant L, Skingley G, Schuttelaar MLA. Development and Psychometric Validation of a Patient-Reported Outcome Measure to Assess the Signs and Symptoms of Chronic Hand Eczema: The Hand Eczema Symptom Diary (HESD). Dermatol Ther (Heidelb). 2024 Mar;14(3):643-669. doi: 10.1007/s13555-024-01114-2. Epub 2024 Mar 15.
Individual participant dataSharing planned: No

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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

54 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Delgocitinib cream in people with Chronic Hand Eczema, run by LEO Pharma at 54 sites in 6 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in France, Canada, Germany, Poland, Italy and 1 more country. 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. Some participants in this study may receive a placebo. 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 23 Sep 2024). 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?

Number of Participants With IGA-CHE TS at Week 16 (time frame: 16 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 NCT04871711, which also lists 5 linked publications.

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 8 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.