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Chronic Hand EczemaPhase 3DELTA 2NCT04872101

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)

A Phase 3 study testing Delgocitinib cream in people with Chronic Hand Eczema, run by LEO Pharma at 50 sites in 7 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

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
473 participants
Where
50 sitesin 7 countries
Study dates
25 May 2021to 6 Jan 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 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

50 sites in 7 countries.

50 sites in 7 countries

Canada10 sites

  • LEO Investigational Site

    Ajax, Ontario, L1S 7K8

  • LEO Investigational Site

    Cobourg, Ontario, K9A 4J9

  • LEO Investigational Site

    Etobicoke, Ontario, M8X 1Y9

  • LEO Investigational Site

    Fredericton, New Brunswick, E3B 1G9

  • LEO Investigational Site

    Hamilton, Ontario, L8S 1G5

  • LEO Investigational Site

    Surrey, British Columbia, V3R 6A7

  • LEO Investigational Site

    Toronto, Ontario, M2M 4J5

  • LEO Investigational Site

    Vancouver, British Columbia, V6H4E1

  • LEO Investigational Site

    Waterloo, Ontario, N2J 1C4

  • LEO Investigational Site

    Windsor, Ontario, N8W 1E6

Other trials in Canada

Germany10 sites

  • LEO Investigational Site

    Aachen, 52074

  • LEO Investigational Site

    Bad Bentheim, 48455

  • LEO Investigational Site

    Frankfurt, 60590

  • LEO Investigational Site

    Friedrichshafen, 88045

  • LEO Invesitgational Site

    Hanover, 30159

  • LEO Investigational Site

    Jena, 07743

  • LEO Investigational Site

    Lübeck, 23538

  • LEO Investigational Site

    Mahlow, 15831

  • LEO Investigational Site

    Münster, 48149

  • LEO Investigational Site

    Stuttgart, 70178

Other trials in Germany

Belgium7 sites

  • LEO Investigational Site

    Brussels, 1000

  • LEO Investigational Site

    Edegem, 2650

  • LEO Investigational Site

    Ghent, 9000

  • LEO Investigational Site

    Kortrijk, 8500

  • LEO Investigational Site

    Leuven, 3000

  • LEO Investigational Site

    Loverval, 6280

  • LEO Investigational Site

    Maldegem, 9990

Other trials in Belgium

Poland7 sites

  • LEO Investigational Site

    Bialystok, 15-375

  • LEO Investigational Site

    Lublin, 20-406

  • LEO Investigational Site

    Rzeszów, 35-055

  • LEO Investigational Site

    Warsaw, 02-625

  • LEO Investigational Site

    Warsaw, 02-962

  • LEO Investigational Site

    Wroclaw, 50-566

  • LEO Investigational Site

    Wroclaw, 51-318

Other trials in Poland

Spain7 sites

  • LEO Investigational Site

    Alicante, 03010

  • LEO Investigational Site

    Badalona, Barcelona, 08915

  • LEO Investigational Site

    Barcelona, 08041

  • LEO Investigational Site

    Bilbao, Vizcaya, 48013

  • LEO Investigational Site

    Madrid, 28031

  • LEO Investigational Site

    Mieres, Principality of Asturias, 33611

  • LEO Investigational Site

    Seville, 41009

Other trials in Spain

Netherlands6 sites

  • LEO Investigational Site

    Amsterdam, 1105 AZ

  • LEO Investigational Site

    Bergen op Zoom, 4614 VT

  • LEO Investigational Site

    Breda, 4818 CK

  • LEO Investigational Site

    Groningen, 9713 GZ

  • LEO Investigational Site

    Hoofddorp, 2134 TM

  • LEO Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Denmark3 sites

  • LEO Investigational Site

    Aarhus, 8200

  • LEO Investigational Site

    Copenhagen, 2400

  • LEO Investigational Site

    Hellerup, 2900

Other trials in Denmark

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 2)

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.

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

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 NCT04872101
Study groupRoleWhat they receive
Delgocitinib cream 20 mg/gExperimentalTwice-daily topical application for 16 weeks
Receives: Drug: Delgocitinib cream
Cream vehiclePlacebo comparatorTwice-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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. Change in HEIS PDAL Score From Baseline to Week 16

    Proximal Daily Activity Limitations (PDAL) is one of the items addressed in the Hand Eczema Impact Scale (HEIS) and is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely).

    Measured: 16 weeks

  23. Number of Participants With 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

  24. 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.

  1. First posted4 May 2021
  2. Study start25 May 2021
  3. Primary completion27 Dec 2022
  4. Study completion6 Jan 2023

Resources

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
473 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04872101
Sponsor's protocol ID
LP0133-1402
Other IDs
2020-002961-32, U1111-1284-2145
Acronym
DELTA 2
Status last verified
Jul 2024
First submitted
29 Apr 2021
Last updated
8 Apr 2025
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

  • Gooderham M, Bunick CG, Yu J, Maslin D, Schneider SKR, Osterdal ML, Sohoel A, Madsen DE, Eichenfield LF. Minimal Systemic Exposure with Maximal Delgocitinib Cream Use in Patients with Severe Chronic Hand Eczema in the DELTA 2 Randomized, Vehicle-Controlled, Double-Blind, Phase 3 Trial. Dermatol Ther (Heidelb). 2026 Jul;16(7):3275-3283. doi: 10.1007/s13555-026-01767-1. Epub 2026 May 17.

    PubMed 42143645

  • 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

  • Gooderham M, Molin S, Bissonnette R, Worm M, Crepy MN, Stingeni L, Warren RB, Schliemann S, Schuttelaar ML, Ferrucci S, Serra-Baldrich E, Silverberg JI, Balita-Crisostomo CL, Osterdal ML, Plohberger U, Agner T. Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials. J Am Acad Dermatol. 2025 Jul;93(1):95-103. doi: 10.1016/j.jaad.2025.03.008. Epub 2025 Mar 11.

    PubMed 40081663

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 50 sites in 7 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 50 sites in Canada, Germany, Belgium, Poland, Spain and 2 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. 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 17 Oct 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 NCT04872101, 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.

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