Chronic Hand EczemaPhase 3DELTA TEENNCT05355818
Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
A Phase 3 study testing Delgocitinib in people with Chronic Hand Eczema, run by LEO Pharma at 37 sites in 7 countries.
Trial summary
The purpose of this trial is to test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- Delgocitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 14 Jul 2022to 17 Dec 2024
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12 to 17 years at screening and baseline.
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
- Disease severity graded as moderate to severe at screening and baseline according to IGA CHE (i.e. an IGA-CHE score of 3 or 4).
- Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
- Inadequate response is defined as a history of failure to achieve and maintain a low disease activity state (comparable to an IGA-CHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent) for Europe and Australia and class IV-I (medium potency to very/ultra-high potency) for Canada, applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter.
- Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, and significant skin atrophy as assessed by the physician.
Who cannot join
- Concurrent skin diseases on the hands, e.g. tinea manuum.
- Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
- Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
- Use of tanning beds, phototherapy (e.g. ultraviolet B (UVB), ultraviolet A1 (UVA1), psoralen ultraviolet A (PUVA)), or bleach baths on the hands within 28 days prior to baseline.
- Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249), systemic or topical.
- Cutaneously applied treatment with immunomodulators (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline.
Show all 12Show fewer
- Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
- Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline.
- Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
- Any disorder which is not stable and could:
- Affect the safety of the subject throughout the trial.
- Impede the subject's ability to complete the trial. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, and major physical impairment.
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
Canada8 sites
LEO Pharma investigational site
Edmonton, T6G 1C3
LEO Pharma investigational site
Fredericton, E3B 1G9
LEO Pharma investigational site
Kingston, K7L 2V7
LEO Pharma investigational site
Montreal, H3T 1C5
LEO Pharma investigational site
Red Deer, T4P1K4
LEO Pharma investigational site
St. John's, NL A1E 1V4
LEO Pharma investigational site
Toronto, M2N 3A6
LEO Pharma investigational site
Winnipeg, R3C 0N2
Poland6 sites
LEO Pharma investigational site
Chorzów, 41-516
LEO Pharma investigational site
Krakow, 30-002
LEO Pharma investigational site
Krakow, 30-033
LEO Pharma investigational site
Krakow, 31-011
LEO Pharma investigational site
Warsaw, 02-625
LEO Pharma investigational site
Wroclaw, 51-503
Spain6 sites
LEO Pharma investigational site
Alicante, 03010
LEO Pharma investigational site
Barcelona, 08041
LEO Pharma investigational site
Cadiz, 11009
LEO Pharma investigational site
Esplugues de Llobregat, 08950
LEO Pharma investigational site
Fuenlabrada, 28942
LEO Pharma investigational site
Granada, 18016
United Kingdom5 sites
LEO Pharma investigational site
Ipswich, IP4 5PD
LEO Pharma investigational site
Kings Lynn, PE30 4ET
LEO Pharma investigational site
Lincoln, LN2 5QY
LEO Pharma investigational site
London, SW10 9NH
LEO Pharma investigational site
Walsall, WS2 9PS
Australia4 sites
LEO Pharma investigational site
Darlinghurst, 2010
LEO Pharma investigational site
Mitcham, 3132
LEO Pharma investigational site
Phillip, 2606
LEO Pharma investigational site
Woolloongabba, 4102
Belgium4 sites
LEO Pharma investigational site
Brussels, 1200
LEO Pharma investigational site
Ghent, 9000
LEO Pharma investigational site
Gilly, 6060
LEO Pharma investigational site
Liège, 4000
France4 sites
LEO Pharma investigational site
Martigues, Bouches-du-Rhône, 13500
LEO Pharma investigational site
Nice, 06000
LEO Pharma investigational site
Reims, 51100
LEO Pharma investigational site
Toulouse, 31059
About this study
Official title: A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)
The purpose of this trial is to test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. At each visit to the clinic, the doctor will assess the severity and extent of CHE, and during the trial, the adolescents will assess their CHE signs and symptoms as well as quality of life.
The trial will last up to 22 weeks and has a 1-4 week screening period, a 16-week treatment period and a 2- week follow-up period. During the treatment period, each adolescent participant will use either the delgocitinib cream or cream vehicle twice daily.
- Conditions
- Chronic Hand Eczema
- Being tested
- Delgocitinib, Cream vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelgocitinibDrug
Cream for topical application
Cream vehicleDrug
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Delgocitinib cream | Experimental | Delgocitinib cream 20 mg/g twice daily Receives: Drug: Delgocitinib |
| Cream vehicle | Placebo comparator | Cream vehicle twice daily 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 Treatment Success at Week 16
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Measured: Week 16
Secondary outcomes (10)
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: Week 16
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 instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points.
Measured: Week 16
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 instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points.
Measured: Week 16
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 instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' The final HESD score is an average of these 6 individual scores. This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of ≥4 points.
Measured: Week 16
Number of Participants With IGA-CHE Treatment Success at Week 2
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Measured: Week 2
Number of Participants With IGA-CHE Treatment Success at Week 4
The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Measured: Week 4
Number of Participants With IGA-CHE Treatment Success at Week 8
The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Measured: Week 8
Number of Participants With IGA-CHE Treatment Success at Week 12
The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Measured: Week 12
Change in CDLQI Score From Baseline to Week 16
The Children's Dermatology Life Quality Index (CDLQI) 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. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI 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: Week 16
Number of Treatment Emergent AEs From Baseline up to Week 18
An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment.
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start14 Jul 2022
- Primary completion5 Dec 2024
- Study completion17 Dec 2024
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355818
- Sponsor's protocol ID
- LP0133-1426
- Other IDs
- 2021-006340-27, U1111-1284-2122
- Acronym
- DELTA TEEN
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2022
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Molin S, Baselga E, Navarro-Trivino FJ, Reguiai Z, Schepper S, Halpern J, Marcoux D, Su JC, Brzewski P, Antonsen SD, Hiort LC, Sohoel A, Thogersen P, Rubel D. Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial. Lancet Child Adolesc Health. 2026 Aug;10(8):552-561. doi: 10.1016/S2352-4642(26)00098-2. Epub 2026 Jun 3.
PubMed 42235562
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)
- ClinicalTrials.gov ID
- NCT05355818
- Acronym / sponsor ID
- DELTA TEEN / LP0133-1426
- Conditions
- Chronic Hand Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Posted 2 Jul 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 test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. At each visit to the clinic, the doctor will assess the severity and extent of CHE, and during the trial, the adolescents will assess their CHE signs and symptoms as well as quality of life.
The trial will last up to 22 weeks and has a 1-4 week screening period, a 16-week treatment period and a 2- week follow-up period. During the treatment period, each adolescent participant will use either the delgocitinib cream or cream vehicle twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delgocitinib cream | Experimental | Drug: DelgocitinibDelgocitinib cream 20 mg/g twice daily |
| Cream vehicle | Placebo comparator | Drug: Cream vehicleCream vehicle twice daily |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 12 to 17 years at screening and baseline.
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
- Disease severity graded as moderate to severe at screening and baseline according to IGA CHE (i.e. an IGA-CHE score of 3 or 4).
- Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
Key exclusion criteria (12 listed)
- Concurrent skin diseases on the hands, e.g. tinea manuum.
- Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
- Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
- Use of tanning beds, phototherapy (e.g. ultraviolet B (UVB), ultraviolet A1 (UVA1), psoralen ultraviolet A (PUVA)), or bleach baths on the hands within 28 days prior to baseline.
- Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249), systemic or topical.
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 | Drug | Delgocitinib cream |
| Cream vehicleThe cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient. | Drug | Cream vehicle |
Primary outcome
Number of Participants With IGA-CHE Treatment Success at Week 16
Time frame: Week 16
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
10 secondary outcomes
Number of Participants With HECSI-90 at Week 16
Time frame: Week 16
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Time frame: Week 16
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Time frame: Week 16
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Time frame: Week 16
Number of Participants With IGA-CHE Treatment Success at Week 2
Time frame: Week 2
Number of Participants With IGA-CHE Treatment Success at Week 4
Time frame: Week 4
Number of Participants With IGA-CHE Treatment Success at Week 8
Time frame: Week 8
Number of Participants With IGA-CHE Treatment Success at Week 12
Time frame: Week 12
Change in CDLQI Score From Baseline to Week 16
Time frame: Week 16
Number of Treatment Emergent AEs From Baseline up to Week 18
Time frame: Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 42235562Molin S, Baselga E, Navarro-Trivino FJ, Reguiai Z, Schepper S, Halpern J, Marcoux D, Su JC, Brzewski P, Antonsen SD, Hiort LC, Sohoel A, Thogersen P, Rubel D. Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial. Lancet Child Adolesc Health. 2026 Aug;10(8):552-561. doi: 10.1016/S2352-4642(26)00098-2. Epub 2026 Jun 3.
- 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
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Delgocitinib in people with Chronic Hand Eczema, run by LEO Pharma at 37 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?
The sponsor lists 6 inclusion and 12 exclusion criteria. 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Canada, Poland, Spain, United Kingdom, Australia 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 2 Jul 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?
Number of Participants With IGA-CHE Treatment Success at Week 16 (time frame: Week 16). 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 NCT05355818, 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 21 Aug 2026.