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NCT01998984 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
A Phase 2 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 266
- Enrollment target
NCT01998984: Completed Phase 2 study, sponsored by LEO Pharma.
NCT01998984 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 266 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01998984, a Phase 2 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 266 participants
- Enrollment target
Study Summary
This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel
Primary Outcome
Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in number of AKs. The table presents the mean across 1000 multiple imputations. Missing values for AK count were imputed sequentially from a negative binomial regression model with treatment group, AK counts at the previous visit, and analysis site as covariates and log baseline AK count as offset.
Interventions
- OTHER Placebo
- DRUG ingenol mebutate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01998984 record still lists
NCT01998984 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01998984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01998984 about?
NCT01998984 is a clinical study titled "Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis". This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel
What is the current status of trial NCT01998984?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 266 participants. The study started on 2014-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01998984?
The interventions under investigation include: Placebo (OTHER), ingenol mebutate (DRUG).
Who is sponsoring clinical trial NCT01998984?
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 NCT01998984's enrollment target sits among peer trials
266 209th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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