Trial · NCT03683719
Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema
NCT03683719, Phase 2, Completed, LEO Pharma; results first posted 2021-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema. Trials, record NCT03683719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03683719
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema
- NCT number
- NCT03683719
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 258 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Chronic Hand Eczema
- Interventions
- Delgocitinib cream, Delgocitinib cream vehicle
- First posted
- 2018-09-25
- Last updated
- 2025-03-12
- Results first posted
- 2021-04-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16. | Week 0 to Week 16. | IGA-CHE is an instrument used in clinical trials to rate the severity of subject's global disease stage and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle. |
| Secondary | Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16. | Week 0 to Week 16. | HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The lowest HECSI score is 0 and the highest possible is 360. A higher HECSI score is indicating more severe hand eczema. The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. A mixed model for repeated measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib cream doses and delgocitinib cream vehicle. |
| Secondary | Time to IGA-CHE Treatment Success. | Week 0 to Week 16. | Time to IGA-CHE treatment success response is defined as the time from baseline to first assessment of an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16. | Week 0 to Week 16. | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16. | Week 0 to Week 16. | FAS | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to IGA-CHE Treatment Success. | Week 0 to Week 16. | FAS | days, median | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16. | Delgocitinib Cream 1 mg/g | 11 | Participants | ||
| Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16. | Delgocitinib Cream 3 mg/g | 4 | Participants | ||
| Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16. | Delgocitinib Cream 8 mg/g | 19 | Participants | ||
| Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16. | Delgocitinib Cream 20 mg/g | 20 | Participants | ||
| Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16. | Delgocitinib Cream Vehicle | 4 | Participants | ||
| Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16. | Delgocitinib Cream 1 mg/g | -39.81 | Standard Error 3.71 | score on a scale | |
| Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16. | Delgocitinib Cream 3 mg/g | -35.93 | Standard Error 3.77 | score on a scale | |
| Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16. | Delgocitinib Cream 8 mg/g | -46.69 | Standard Error 3.63 | score on a scale | |
| Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16. | Delgocitinib Cream 20 mg/g | -41.99 | Standard Error 3.59 | score on a scale | |
| Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16. | Delgocitinib Cream Vehicle | -26.40 | Standard Error 3.80 | score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Delgocitinib Cream 1 mg/g | 52 | |
| Overall Study | STARTED | Delgocitinib Cream 3 mg/g | 51 | |
| Overall Study | STARTED | Delgocitinib Cream 8 mg/g | 52 | |
| Overall Study | STARTED | Delgocitinib Cream 20 mg/g | 53 | |
| Overall Study | STARTED | Delgocitinib Cream Vehicle | 50 | |
| Overall Study | COMPLETED | Delgocitinib Cream 1 mg/g | 40 | |
| Overall Study | COMPLETED | Delgocitinib Cream 3 mg/g | 38 | |
| Overall Study | COMPLETED | Delgocitinib Cream 8 mg/g | 44 | |
| Overall Study | COMPLETED | Delgocitinib Cream 20 mg/g | 46 | |
| Overall Study | COMPLETED | Delgocitinib Cream Vehicle | 36 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events55
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 | Nasopharyngitis | Infections and infestations | Delgocitinib Cream 1 mg/g | 9 | 52 | 11 |
| other | Nasopharyngitis | Infections and infestations | Delgocitinib Cream 3 mg/g | 15 | 51 | 22 |
| other | Nasopharyngitis | Infections and infestations | Delgocitinib Cream 8 mg/g | 15 | 52 | 16 |
| other | Nasopharyngitis | Infections and infestations | Delgocitinib Cream 20 mg/g | 14 | 53 | 20 |
| other | Nasopharyngitis | Infections and infestations | Delgocitinib Cream Vehicle | 20 | 50 | 20 |
| other | Eczema | Skin and subcutaneous tissue disorders | Delgocitinib Cream 1 mg/g | 5 | 52 | 5 |
| other | Eczema | Skin and subcutaneous tissue disorders | Delgocitinib Cream 3 mg/g | 4 | 51 | 5 |
| other | Eczema | Skin and subcutaneous tissue disorders | Delgocitinib Cream 8 mg/g | 3 | 52 | 7 |
| other | Eczema | Skin and subcutaneous tissue disorders | Delgocitinib Cream 20 mg/g | 6 | 53 | 7 |
| other | Eczema | Skin and subcutaneous tissue disorders | Delgocitinib Cream Vehicle | 8 | 50 | 9 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delgocitinib Cream 1 mg/g | 0 | 52 |
| Total, all-cause mortality | Delgocitinib Cream 3 mg/g | 0 | 51 |
| Total, all-cause mortality | Delgocitinib Cream 8 mg/g | 0 | 52 |
| Total, all-cause mortality | Delgocitinib Cream 20 mg/g | 0 | 53 |
| Total, all-cause mortality | Delgocitinib Cream Vehicle | 0 | 50 |
| Total, other adverse events | Delgocitinib Cream 1 mg/g | 20 | 52 |
| Total, other adverse events | Delgocitinib Cream 3 mg/g | 25 | 51 |
| Total, other adverse events | Delgocitinib Cream 8 mg/g | 25 | 52 |
| Total, other adverse events | Delgocitinib Cream 20 mg/g | 26 | 53 |
| Total, other adverse events | Delgocitinib Cream Vehicle | 24 | 50 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03683719
GET https://conductscience.org/api/trials/v1/NCT03683719/events?page=2