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NCT02600598 · ClinicalTrials.gov registry record · Phase 1
Biological Effects of LEO 43204 in Actinic Keratosis
A Phase 1 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02600598 is a Phase 1 study that has completed, run by LEO Pharma. The registered enrollment target is 24 participants.
The verdict
NCT02600598, a Phase 1 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a Phase I, single-centre, open label, within-subject comparison trial to explore the biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in patients with actinic keratosis on the upper extremity. The treatment area for each patient will be as defined as a contiguous area of 250 cm2 of skin on the upper extremity (including the dorsum manus) that contains a minimum of 5 AK lesions. Additionally there must be at least one AK lesion located in a non-treated area on the contralateral arm. All eligible subjects will receive LEO 43204 Gel, 0.037%, on the treatment area on Days 1, 2 and 3. Study medication application will be (sub)investigator applied. A total of 30 patients will be enrolled into this study (n=15 in each of the two groups). Patients will be divided into two groups with different biopsy schedules.
Interventions
- DRUG LEO 43204 Gel, 0.037%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-07 |
| Est. Completion | 2017-01-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02600598
The ClinicalTrials.gov registry entry for NCT02600598 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 LEO 43204 Gel, 0.037% is the first listed.
NCT02600598 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02600598 about?
NCT02600598 is a clinical study titled "Biological Effects of LEO 43204 in Actinic Keratosis". This is a Phase I, single-centre, open label, within-subject comparison trial to explore the biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in patients with actinic keratosis on the upper extremity. The treatment area for each patient will be as defined as a c...
What is the current status of trial NCT02600598?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-07. Estimated completion is 2017-01-16.
What interventions are being tested in trial NCT02600598?
The interventions under investigation include: LEO 43204 Gel, 0.037% (DRUG).
Who is sponsoring clinical trial NCT02600598?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
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