Trial · NCT05259722
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
NCT05259722, Phase 3, Completed, LEO Pharma; results first posted 2025-03-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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. Trials, record NCT05259722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05259722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT05259722
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 513 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Chronic Hand Eczema
- Interventions
- Delgocitinib, Toctino
- First posted
- 2022-02-28
- Last updated
- 2025-05-09
- Other registries' IDs
- eudract:2021-003543-16
- Results first posted
- 2025-03-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HECSI Score From Baseline to Week 12 | 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. |
| Secondary | HECSI-90 at Week 12 | 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. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline. |
| Secondary | IGA-CHE TS at Week 12. | 12 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. |
| Secondary | Change in HESD Itch Score (Weekly Average) From Baseline to Week 12 | 12 weeks | 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. |
| Secondary | Change in HESD Pain Score (Weekly Average) From Baseline to Week 12. | 12 weeks | 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. |
| Secondary | AUC of HECSI-90 From Baseline up to Week 24 | 24 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. 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. |
| Secondary | AUC of Change From Baseline in DLQI Score up to Week 24 | 24 weeks | 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. |
| Secondary | Change in HECSI Score From Baseline to Week 24 | 24 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. |
| Secondary | Number of Treatment-emergent AEs From Baseline up to Week 26 | 26 weeks | 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. |
| Secondary | Number of Treatment-emergent SAEs From Baseline up to Week 26 | 26 weeks | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in HECSI Score From Baseline to Week 12 | 12 weeks | score on a scale | MEAN | |
| SECONDARY | HECSI-90 at Week 12 | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | IGA-CHE TS at Week 12. | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in HESD Itch Score (Weekly Average) From Baseline to Week 12 | 12 weeks | score on a scale | MEAN | |
| SECONDARY | Change in HESD Pain Score (Weekly Average) From Baseline to Week 12. | 12 weeks | score on a scale | MEAN | |
| SECONDARY | AUC of HECSI-90 From Baseline up to Week 24 | 24 weeks | days with 90% reduction in HECSI score | MEAN | |
| SECONDARY | AUC of Change From Baseline in DLQI Score up to Week 24 | 24 weeks | days * DLQI score reduction | MEAN | |
| SECONDARY | Change in HECSI Score From Baseline to Week 24 | 24 weeks | score on a scale | MEAN | |
| SECONDARY | Number of Treatment-emergent AEs From Baseline up to Week 26 | 26 weeks | events | NUMBER | |
| SECONDARY | Number of Treatment-emergent SAEs From Baseline up to Week 26 | 26 weeks | events | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in HECSI Score From Baseline to Week 12 | Delgocitinib Cream 20 mg/g | -67.6 | Standard Error 3.37 | score on a scale | |
| Change in HECSI Score From Baseline to Week 12 | Alitretinoin Capsules 30 mg Per Capsule | -51.5 | Standard Error 3.36 | score on a scale | |
| HECSI-90 at Week 12 | Delgocitinib Cream 20 mg/g | 96 | Participants | ||
| HECSI-90 at Week 12 | Alitretinoin Capsules 30 mg Per Capsule | 65 | Participants | ||
| IGA-CHE TS at Week 12. | Delgocitinib Cream 20 mg/g | 68 | Participants | ||
| IGA-CHE TS at Week 12. | Alitretinoin Capsules 30 mg Per Capsule | 42 | Participants | ||
| Change in HESD Itch Score (Weekly Average) From Baseline to Week 12 | Delgocitinib Cream 20 mg/g | -3.0 | Standard Error 0.22 | score on a scale | |
| Change in HESD Itch Score (Weekly Average) From Baseline to Week 12 | Alitretinoin Capsules 30 mg Per Capsule | -2.4 | Standard Error 0.21 | score on a scale | |
| Change in HESD Pain Score (Weekly Average) From Baseline to Week 12. | Delgocitinib Cream 20 mg/g | -2.9 | Standard Error 0.23 | score on a scale | |
| Change in HESD Pain Score (Weekly Average) From Baseline to Week 12. | Alitretinoin Capsules 30 mg Per Capsule | -2.3 | Standard Error 0.23 | score on a scale |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Delgocitinib Cream 20 mg/g | 254 | |
| Overall Study | STARTED | Alitretinoin Capsules 30 mg Per Capsule | 259 | |
| Overall Study | COMPLETED | Delgocitinib Cream 20 mg/g | 219 | |
| Overall Study | COMPLETED | Alitretinoin Capsules 30 mg Per Capsule | 154 | |
| Overall Study | NOT COMPLETED | Delgocitinib Cream 20 mg/g | 35 | |
| Overall Study | NOT COMPLETED | Alitretinoin Capsules 30 mg Per Capsule | 105 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry eye | Eye disorders | Delgocitinib Cream 20 mg/g | 0 | 253 | 0 |
| other | Dry eye | Eye disorders | Alitretinoin Capsules 30 mg Per Capsule | 7 | 247 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Delgocitinib Cream 20 mg/g | 0 | 253 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Alitretinoin Capsules 30 mg Per Capsule | 5 | 247 | 5 |
| other | Lip dry | Gastrointestinal disorders | Delgocitinib Cream 20 mg/g | 0 | 253 | 0 |
| other | Lip dry | Gastrointestinal disorders | Alitretinoin Capsules 30 mg Per Capsule | 8 | 247 | 8 |
| other | Nausea | Gastrointestinal disorders | Delgocitinib Cream 20 mg/g | 1 | 253 | 1 |
| other | Nausea | Gastrointestinal disorders | Alitretinoin Capsules 30 mg Per Capsule | 14 | 247 | 15 |
| other | COVID-19 | Infections and infestations | Delgocitinib Cream 20 mg/g | 5 | 253 | 5 |
| other | COVID-19 | Infections and infestations | Alitretinoin Capsules 30 mg Per Capsule | 9 | 247 | 9 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delgocitinib Cream 20 mg/g | 0 | 253 |
| Total, all-cause mortality | Alitretinoin Capsules 30 mg Per Capsule | 0 | 247 |
| Total, other adverse events | Delgocitinib Cream 20 mg/g | 58 | 253 |
| Total, other adverse events | Alitretinoin Capsules 30 mg Per Capsule | 143 | 247 |
| Total, serious adverse events | Delgocitinib Cream 20 mg/g | 5 | 253 |
| Total, serious adverse events | Alitretinoin Capsules 30 mg Per Capsule | 12 | 247 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40252681 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Delgocitinib Cream 20 mg/g vs Alitretinoin Capsules 30 mg Per Capsule: HECSI-90 at Week 12 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Alitretinoin Capsules 30 mg Per Capsule: IGA-CHE TS at Week 12. | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Alitretinoin Capsules 30 mg Per Capsule: deaths from any cause | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Alitretinoin Capsules 30 mg Per Capsule: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05259722
GET https://conductscience.org/api/trials/v1/NCT05259722/results?page=2