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NCT02654769 · ClinicalTrials.gov registry record · Phase 3

A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis

A Phase 3 study of Actinic Keratosis, sponsored by Actavis.

Completed
Registry status
Phase 3
Development phase
441
Enrollment target
20
Study locations

NCT02654769 is a Phase 3 study of Actinic Keratosis that has completed, run by Actavis. The registered enrollment target is 441 participants, above the 161-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (174% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT02654769, a Phase 3 study of Actinic Keratosis, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 3
Development phase
441 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.

Conditions Studied

Interventions

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

Study Locations (20)

Florida

  • The Center for Clinical and Cosmetic Research - Aventura
  • Savin Medical Group Research Center - Miami Lakes
  • Tory P. Sullivan, M.D., P.A. - North Miami Beach
  • Moore Clinical Research, Inc. - Tampa

Indiana

  • Shideler Clinical Research Center - Carmel
  • Dawes Fretzin Clinical Research Group, LLC - Indianapolis
  • The Indiana Clinical Trials Center - Plainfield

California

  • Center for Dermatology Clinical Research, Inc - Fremont
  • SD Sports Medicine & Family Health Center - San Diego

Illinois

  • Altman Dermatology Associates - Arlington Heights
  • Christie Clinic, LLC - Champaign

North Carolina

  • Dermatology Consulting Services - High Point
  • PMG Research of Winston-Salem, LLC - Winston-Salem

Idaho

  • Northwest Clinical Trials, Inc. - Boise

Nevada

  • Bettencourt Skin Center - Henderson

New York

  • Union Square Dermatology - New York

Trial Details

FieldValue
Enrollment Target 441 participants
Start Date 2015-02
Est. Completion 2015-09
Phase Phase 3

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT02654769

The ClinicalTrials.gov registry entry for NCT02654769 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 441 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 161-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (174% higher). The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Actinic Keratosis appearing as the primary indexed condition, and to 3 interventions - of which Vehicle Foam is the first listed.

NCT02654769 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Indiana, California.

Frequently Asked Questions

What is clinical trial NCT02654769 about?

NCT02654769 is a clinical study titled "A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis". The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extrem...

What is the current status of trial NCT02654769?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 441 participants. The study started on 2015-02. Estimated completion is 2015-09.

What conditions does trial NCT02654769 study?

This clinical trial studies the following conditions: Actinic Keratosis.

What interventions are being tested in trial NCT02654769?

The interventions under investigation include: Vehicle Foam (DRUG), Ingenol Mebutate (Picato®) (DRUG), Generic Ingenol Mebutate (DRUG).

Who is sponsoring clinical trial NCT02654769?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02654769 being conducted?

This trial has 20 study locations across California, Florida, Idaho, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.