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NCT02124239 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions
A Phase 1 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
NCT02124239 is a Phase 1 study that has completed, run by LEO Pharma. The registered enrollment target is 79 participants.
The verdict
NCT02124239, a Phase 1 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
Study Summary
This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 10 clinically typical, visible, and discrete AKs on the face, balding scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin. There will be 3 treatment groups: (1) once daily application of ingenol mebutate gel 0.027% on the full face for three consecutive days, (2) the same regimen on the balding scalp, and (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of approximately 250 cm2 for four consecutive days.
Interventions
- DRUG Ingenol mebutate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02124239
The ClinicalTrials.gov registry entry for NCT02124239 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ingenol mebutate is the first listed.
NCT02124239 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02124239 about?
NCT02124239 is a clinical study titled "Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions". This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 10 clinically typical, visible, and discrete AKs on the face,...
What is the current status of trial NCT02124239?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2014-04. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02124239?
The interventions under investigation include: Ingenol mebutate (DRUG).
Who is sponsoring clinical trial NCT02124239?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
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