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

April 30, 2020 updated by: Actavis Inc.

Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Study to Determine the Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato® Gel 0.05% in Subjects With Actinic Keratosis on the Trunk or Extremities

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.

Study Overview

Detailed Description

Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has been developed for the topical treatment of clinically typical, visible, and discrete non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.

Study Type

Interventional

Enrollment (Actual)

441

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc
      • San Diego, California, United States, 92120
        • SD Sports Medicine & Family Health Center
    • Florida
      • Aventura, Florida, United States, 33180
        • The Center for Clinical and Cosmetic Research
      • Miami Lakes, Florida, United States, 33014
        • Savin Medical Group Research Center
      • North Miami Beach, Florida, United States, 33162
        • Tory P. Sullivan, M.D., P.A.
      • Tampa, Florida, United States, 33609
        • MOORE Clinical Research, Inc.
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials, Inc.
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Altman Dermatology Associates
      • Champaign, Illinois, United States, 61820
        • Christie Clinic, LLC
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Shideler Clinical Research Center
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group, LLC
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Bettencourt Skin Center
    • New York
      • New York, New York, United States, 10003
        • Union Square Dermatology
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Greenville Dermatology, LLC
    • Tennessee
      • Knoxville, Tennessee, United States, 37917
        • Dermatology Associates of Knoxville, PC
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch, Inc.Austin
      • Houston, Texas, United States, 77056
        • The Center for Skin Research
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject was a male or non-pregnant female 18 years of age or older
  • Subject provided written informed consent.
  • Subject was willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
  • Subject had a clinical diagnosis of AK at Baseline with at least four (4), but no more than eight (8), visible and discrete non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in diameter, within a contiguous 25 cm2 treatment area ("the Treatment Area") on the trunk or extremities.
  • Subject was in good general health and free of any disease state or physical condition that might have impaired evaluation of AK lesions or which, in the investigator's opinion, exposed the subject to an unacceptable risk by study participation.
  • Females must have been post-menopausal , surgically sterile , or have used an effective method of birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.

Exclusion Criteria:

  • Subject was pregnant, lactating, or was planning to become pregnant during the study.
  • Subject was currently enrolled in an investigational drug or device study.
  • Subject used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
  • Subject had hyperkeratotic, hypertrophic, or large mat-like AKs (e.g., AK >1 cm2 in size) within the contiguous 25 cm2 Treatment Area.
  • Subject had more than eight (8) AKs, independent of size, within the contiguous 25 cm2 Treatment Area.
  • Subject had the need or planned to be exposed to artificial tanning devices or excessive sunlight during the trial.
  • Subject was immunosuppressed (e.g., HIV, systemic malignancy, graft host disease, etc.)
  • Subject had experienced an unsuccessful outcome from previous ingenol mebutate therapy (an unsuccessful outcome was defined as after a reasonable therapeutic trial with no compliance issues and the topical drug did not work).
  • Subject had a history of sensitivity to any of the ingredients in the test articles (see Section 9.4.2).
  • Subject used topical creams, lotions, or gels of any kind within the selected Treatment Area within one (1) day prior to entry into the study.
  • Subject used topical medications; corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) within the selected Treatment Area (trunk or extremities) within one (1) month prior to the Baseline Visit.
  • Subject had cryodestruction, curettage, photodynamic therapy, surgical excision, or other treatments for AK within the selected Treatment Area (trunk or extremities) within one (1) month prior to the Baseline Visit.
  • Subject used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within one (1) month prior to the Baseline Visit.
  • Subject had dermatologic procedures or surgeries such as laser resurfacing, Psoralen + ultraviolet A (PUVA) therapy, ultraviolet B (UVB) therapy, chemical peels, or dermabrasion on the selected Treatment area (trunk or extremities) within six (6) months prior to the Baseline Visit.
  • Subject had lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected Treatment Area (trunk or extremities).
  • Subject had any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the test article or required the use of interfering topical, systemic, or surgical therapy.
  • Subject had any condition which, in the investigator's opinion, would have made it unsafe or precluded the subject's ability to fully participate in this research study.
  • Subject was unable to communicate or cooperate with the investigator due to language problems, poor mental development, impaired cerebral function, or physical limitations.
  • Subject was known to be noncompliant or was unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
  • Subject had been previously enrolled in the same study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle Foam
Vehicle gel of the test product
It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
Other Names:
  • Placebo
Active Comparator: Active Comparator Picato®
Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) [Reference Listed Drug (RLD)]
Brand product
Other Names:
  • Picato
Experimental: Generic Ingenol Mebutate
Generic ingenol mebutate gel, 0.05% [Test]
Generic formulated to have the same therapeutic effect of the brand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Outcome Measure
Time Frame: 8 weeks
Percentage of subjects in the PP population in each treatment group with complete clearance of AK lesions. Complete clearance was defined as having no (zero) clinically visible AK lesions in the Treatment Area at the Week 8 visit.
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The Percentage of Subjects in the PP Population in Each Treatment Group With Partial Clearance (as Having at Least 75% Reduction in the Number of Clinically Visible AK Lesions) in theTreatment Area at the Week 8 Visit.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Oleg Khatsenko, Ph.D, Actavis Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 094-8151-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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