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NCT01820260 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis
A Phase 1 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 395
- Enrollment target
NCT01820260: Completed Phase 1 study, sponsored by LEO Pharma.
NCT01820260 is a Phase 1 study that has completed, run by LEO Pharma. The registered enrollment target is 395 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (558% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01820260, a Phase 1 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 395 participants
- Enrollment target
Study Summary
To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel
Primary Outcome
Dose tolerability was measures looking at the composite score of Local Skin Responses (LSR). The MTD was defined as the highest dose level with less than 4 subjects out of 12 experiencing dose limiting toxicity (DLT). DLT was defined as one or more of the following three local skin LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 or two or more of the following five LSRs: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade
Interventions
- DRUG placebo
- DRUG Ingenol mebutate gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01820260 record still lists
NCT01820260 is an interventional study that assigns participants to a tested intervention. The registered 395 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 (558% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01820260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01820260 about?
NCT01820260 is a clinical study titled "Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis". To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel
What is the current status of trial NCT01820260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 395 participants. The study started on 2013-04. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01820260?
The interventions under investigation include: placebo (DRUG), Ingenol mebutate gel (DRUG).
Who is sponsoring clinical trial NCT01820260?
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 NCT01820260's enrollment target sits among peer trials
395 77th of 2000 higher than 1,924 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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