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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 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 507 participants.

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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.

Interventions

  • DRUG Vehicle Foam
  • DRUG Ingenol Mebutate (Picato®)
  • DRUG Generic Ingenol Mebutate

Trial Details

FieldValue
Enrollment Target 507 participants
Start Date 2016-08-19
Est. Completion 2017-03-22
Phase Phase 3

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT03200912

The ClinicalTrials.gov registry entry for NCT03200912 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 507 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Vehicle Foam is the first listed.

NCT03200912 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.