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NCT03683719 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 258
- Enrollment target
NCT03683719: Completed Phase 2 study, sponsored by LEO Pharma.
NCT03683719 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 258 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03683719, a Phase 2 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 258 participants
- Enrollment target
Study Summary
The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.
Primary Outcome
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.
Interventions
- DRUG Delgocitinib cream
- DRUG Delgocitinib cream vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2018-11-28 |
| Est. Completion | 2020-04-20 |
| Phase | Phase 2 |
What the finished NCT03683719 record still lists
NCT03683719 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher).
The record links to 0 conditions, and to 2 interventions - of which Delgocitinib cream is the first listed.
NCT03683719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03683719 about?
NCT03683719 is a clinical study titled "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". The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of ...
What is the current status of trial NCT03683719?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2018-11-28. Estimated completion is 2020-04-20.
What interventions are being tested in trial NCT03683719?
The interventions under investigation include: Delgocitinib cream (DRUG), Delgocitinib cream vehicle (DRUG).
Who is sponsoring clinical trial NCT03683719?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03683719's enrollment target sits among peer trials
258 212th of 2000 higher than 1,787 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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