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NCT02361216 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
A Phase 3 study of Actinic Keratosis, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 729
- Enrollment target
- 1
- Study location
NCT02361216: Completed Phase 3 study of Actinic Keratosis, sponsored by LEO Pharma.
NCT02361216 is a Phase 3 study of Actinic Keratosis that has completed, run by LEO Pharma. The registered enrollment target is 729 participants, above the 143-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (410% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02361216, a Phase 3 study of Actinic Keratosis, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 729 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.
Primary Outcome
Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs
Conditions Studied
Interventions
- OTHER Vehicle
- DRUG Ingenol Mebutate
Study Locations (1)
Indiana
- Laser & Skin Surgery Center of Indiana - Carmel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 729 participants |
| Start Date | 2015-04 |
| Est. Completion | 2017-03 |
| Phase | Phase 3 |
What the finished NCT02361216 record still lists
NCT02361216 is an interventional study that assigns participants to a tested intervention. The registered 729 participants enrollment target is mid-sized for trials with a published cap, above the 143-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (410% higher).
The record links to 1 condition, with Actinic Keratosis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT02361216 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT02361216 about?
NCT02361216 is a clinical study titled "Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest". The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.
What is the current status of trial NCT02361216?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 729 participants. The study started on 2015-04. Estimated completion is 2017-03.
What conditions does trial NCT02361216 study?
This clinical trial studies the following conditions: Actinic Keratosis.
What interventions are being tested in trial NCT02361216?
The interventions under investigation include: Vehicle (OTHER), Ingenol Mebutate (DRUG).
Who is sponsoring clinical trial NCT02361216?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02361216 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Actinic Keratosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02361216's enrollment target sits among peer trials
729 1st of 16 higher than 16 of 16 other Actinic Keratosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratosis 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
-
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
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-
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-
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
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Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
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A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
COMPLETED · Phase 3
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