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NCT03200912 · ClinicalTrials.gov registry record · Phase 3
An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 507
- Enrollment target
NCT03200912: Completed Phase 3 study, sponsored by Actavis.
NCT03200912 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 507 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03200912, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 507 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.
Primary Outcome
Treatment success (complete clearance of AK lesions) at Day 57, where complete clearance of AK lesions was defined as having no (zero) clinically visible AK lesions in the Treatment Area
Interventions
- DRUG Vehicle Foam
- DRUG Ingenol Mebutate (Picato®)
- DRUG Generic Ingenol Mebutate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2016-08-19 |
| Est. Completion | 2017-03-22 |
| Phase | Phase 3 |
What the finished NCT03200912 record still lists
NCT03200912 is an interventional study that assigns participants to a tested intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 3 interventions - of which Vehicle Foam is the first listed.
NCT03200912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03200912 about?
NCT03200912 is a clinical study titled "An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis". The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatme...
What is the current status of trial NCT03200912?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2016-08-19. Estimated completion is 2017-03-22.
What interventions are being tested in trial NCT03200912?
The interventions under investigation include: Vehicle Foam (DRUG), Ingenol Mebutate (Picato®) (DRUG), Generic Ingenol Mebutate (DRUG).
Who is sponsoring clinical trial NCT03200912?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03200912's enrollment target sits among peer trials
507 739th of 2000 higher than 1,260 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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