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NCT02650505 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
A Phase 1 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 233
- Enrollment target
NCT02650505: Completed Phase 1 study, sponsored by LEO Pharma.
NCT02650505 is a Phase 1 study that has completed, run by LEO Pharma. The registered enrollment target is 233 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (288% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02650505, a Phase 1 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 233 participants
- Enrollment target
Study Summary
This is a randomized, single-center, controlled, within-subject comparison study assessing the sensitization potential of the investigational product, LEO 43204 gel under open conditions in healthy volunteers. LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of the back. Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema and other signs of cutaneous irritation. Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will enter the Challenge Phase, which consists of one 48-hour application to a naive site on the opposite side of the back. Observations at the naive site during Challenge and the patterns of reactivity during the Induction Phase will provide a basis for an interpretation of contact sensitization. A total of 10 applications will be made over a period of approximately 6-8 weeks.
Interventions
- DRUG LEO 43204
- DRUG LEO 43204 Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2016-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02650505 record still lists
NCT02650505 is an interventional study that assigns participants to a tested intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (288% higher).
The record links to 0 conditions, and to 2 interventions - of which LEO 43204 is the first listed.
NCT02650505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02650505 about?
NCT02650505 is a clinical study titled "A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel". This is a randomized, single-center, controlled, within-subject comparison study assessing the sensitization potential of the investigational product, LEO 43204 gel under open conditions in healthy volunteers. LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area...
What is the current status of trial NCT02650505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 233 participants. The study started on 2016-02. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02650505?
The interventions under investigation include: LEO 43204 (DRUG), LEO 43204 Vehicle (DRUG).
Who is sponsoring clinical trial NCT02650505?
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 NCT02650505's enrollment target sits among peer trials
233 214th of 2000 higher than 1,785 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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