Trial · NCT04871711
Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema
NCT04871711, Phase 3, Completed, LEO Pharma; results first posted 2024-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema. Trials, record NCT04871711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04871711
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema
- NCT number
- NCT04871711
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 487 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Chronic Hand Eczema
- Interventions
- Delgocitinib cream, Cream vehicle
- First posted
- 2021-05-04
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2020-002960-30
- Results first posted
- 2024-09-23
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With IGA-CHE TS at Week 16 | 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. |
| Secondary | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 16 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 and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points. |
| Secondary | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 16 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. 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. |
| Secondary | Number of Participants With IGA-CHE TS at Week 8 | 8 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 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 | Number of Participants With IGA-CHE TS at Week 4 | 4 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 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 | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 8 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 and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points. |
| Secondary | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 4 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 and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points. |
| Secondary | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2 | 2 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 and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points. |
| Secondary | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 8 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. 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. |
| Secondary | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 4 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. 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. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With IGA-CHE TS at Week 16 | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With IGA-CHE TS at Week 8 | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With IGA-CHE TS at Week 4 | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2 | 2 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 4 weeks | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With IGA-CHE TS at Week 16 | Delgocitinib Cream 20 mg/g | 64 | Participants | ||
| Number of Participants With IGA-CHE TS at Week 16 | Cream Vehicle | 16 | Participants | ||
| Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Delgocitinib Cream 20 mg/g | 152 | Participants | ||
| Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Cream Vehicle | 37 | Participants | ||
| Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Delgocitinib Cream 20 mg/g | 146 | Participants | ||
| Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Cream Vehicle | 38 | Participants | ||
| Number of Participants With IGA-CHE TS at Week 8 | Delgocitinib Cream 20 mg/g | 74 | Participants | ||
| Number of Participants With IGA-CHE TS at Week 8 | Cream Vehicle | 17 | Participants | ||
| Number of Participants With IGA-CHE TS at Week 4 | Delgocitinib Cream 20 mg/g | 50 | Participants | ||
| Number of Participants With IGA-CHE TS at Week 4 | Cream Vehicle | 8 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 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 | 325 | |
| Overall Study | STARTED | Cream Vehicle | 162 | |
| Overall Study | COMPLETED | Delgocitinib Cream 20 mg/g | 305 | |
| Overall Study | COMPLETED | Cream Vehicle | 141 | |
| Overall Study | NOT COMPLETED | Delgocitinib Cream 20 mg/g | 20 | |
| Overall Study | NOT COMPLETED | Cream Vehicle | 21 |
Source ClinicalTrials.gov
Adverse events32
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 | Allergy to metals | Immune system disorders | Delgocitinib |20 mg/g | 7 | 325 | 7 |
| other | Allergy to metals | Immune system disorders | Vehicle| | 3 | 162 | 3 |
| other | COVID-19 | Infections and infestations | Delgocitinib |20 mg/g | 35 | 325 | 35 |
| other | COVID-19 | Infections and infestations | Vehicle| | 14 | 162 | 14 |
| other | Nasopharyngitis | Infections and infestations | Delgocitinib |20 mg/g | 23 | 325 | 25 |
| other | Nasopharyngitis | Infections and infestations | Vehicle| | 14 | 162 | 16 |
| other | Headache | Nervous system disorders | Delgocitinib |20 mg/g | 9 | 325 | 13 |
| other | Headache | Nervous system disorders | Vehicle| | 4 | 162 | 6 |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | Delgocitinib |20 mg/g | 4 | 325 | 4 |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | Vehicle| | 4 | 162 | 4 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delgocitinib |20 mg/g | 0 | 325 |
| Total, all-cause mortality | Vehicle| | 0 | 162 |
| Total, other adverse events | Delgocitinib |20 mg/g | 69 | 325 |
| Total, other adverse events | Vehicle| | 42 | 162 |
| Total, serious adverse events | Delgocitinib |20 mg/g | 6 | 325 |
| Total, serious adverse events | Vehicle| | 3 | 162 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons19
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With IGA-CHE TS at Week 8 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With HECSI-75 at Week 8 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With IGA-CHE TS at Week 4 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Reduction of DLQI Score of ≥4 Points From Baseline at Week 16 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Trial comparisons |
| Delgocitinib Cream 20 mg/g vs Cream Vehicle: Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Trial comparisons |
1 to 10 of 19
See all 19 trial comparisonsTests0
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/NCT04871711
GET https://conductscience.org/api/trials/v1/NCT04871711/registered?page=2