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NCT02100813 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
A Phase 1 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
NCT02100813: Completed Phase 1 study, sponsored by LEO Pharma.
NCT02100813 is a Phase 1 study that has completed, run by LEO Pharma. The registered enrollment target is 220 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02100813, a Phase 1 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
Study Summary
To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle
Primary Outcome
The number participants experiencing a DLT 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 experiencing a DLT. A DLT was defined as: * Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale * Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT. The
Interventions
- DRUG Placebo
- DRUG LEO 43204
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
What the finished NCT02100813 record still lists
NCT02100813 is an interventional study that assigns participants to a tested intervention. The registered 220 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 (267% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02100813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02100813 about?
NCT02100813 is a clinical study titled "Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis". To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle
What is the current status of trial NCT02100813?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2014-05. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02100813?
The interventions under investigation include: Placebo (DRUG), LEO 43204 (DRUG).
Who is sponsoring clinical trial NCT02100813?
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 NCT02100813's enrollment target sits among peer trials
220 230th of 2000 higher than 1,763 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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