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NCT01922050 · ClinicalTrials.gov registry record · Phase 1
A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis
A Phase 1 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 320
- Enrollment target
NCT01922050: Completed Phase 1 study, sponsored by LEO Pharma.
NCT01922050 is a Phase 1 study that has completed, run by LEO Pharma. The registered enrollment target is 320 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (433% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01922050, a Phase 1 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 320 participants
- Enrollment target
Study Summary
Part 1: To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations
Primary Outcome
The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT DLT was defined as one or more of the following 3 LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pu
Interventions
- DRUG LEO 43204 Formulation 1
- DRUG LEO 43204 Formulation 2
- DRUG LEO 43204 Formulation 1 Dose X
- DRUG LEO 43204 Formulation 1 Dose Y
- DRUG LEO 43204 Formulation 2 Dose XX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01922050 record still lists
NCT01922050 is an interventional study that assigns participants to a tested intervention. The registered 320 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 (433% higher).
The record links to 0 conditions, and to 5 interventions - of which LEO 43204 Formulation 1 is the first listed.
NCT01922050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01922050 about?
NCT01922050 is a clinical study titled "A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis". Part 1: To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulati...
What is the current status of trial NCT01922050?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 320 participants. The study started on 2013-10. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01922050?
The interventions under investigation include: LEO 43204 Formulation 1 (DRUG), LEO 43204 Formulation 2 (DRUG), LEO 43204 Formulation 1 Dose X (DRUG), LEO 43204 Formulation 1 Dose Y (DRUG), LEO 43204 Formulation 2 Dose XX (DRUG).
Who is sponsoring clinical trial NCT01922050?
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 NCT01922050's enrollment target sits among peer trials
320 112th of 2000 higher than 1,885 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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