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

NCT02654769 | Completed Phase 3 Results

• 1 other identifier: 094-8151-301
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 22

Brief 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

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Outcome Measure

  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 Outcomes (1)

• 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.

  8 weeks

Study Arms (3)

Active Comparator Picato®

ACTIVE COMPARATOR

Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]

Drug: Ingenol Mebutate (Picato®)

Generic Ingenol Mebutate

EXPERIMENTAL

Generic ingenol mebutate gel, 0.05% \[Test\]

Drug: Generic Ingenol Mebutate

Vehicle Foam

PLACEBO COMPARATOR

Vehicle gel of the test product

Drug: Vehicle Foam

Interventions

Ingenol Mebutate (Picato®) DRUG

Brand product

Also known as: Picato

Active Comparator Picato®

Generic Ingenol Mebutate DRUG

Generic formulated to have the same therapeutic effect of the brand

Generic Ingenol Mebutate

Vehicle Foam DRUG

It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Also known as: Placebo

Vehicle Foam

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (22)

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

SD Sports Medicine & Family Health Center

San Diego, California, 92120, United States

Location

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Savin Medical Group Research Center

Miami Lakes, Florida, 33014, United States

Location

Tory P. Sullivan, M.D., P.A.

North Miami Beach, Florida, 33162, United States

Location

Moore Clinical Research, Inc.

Tampa, Florida, 33609, United States

Location

Northwest Clinical Trials, Inc.

Boise, Idaho, 83704, United States

Location

Altman Dermatology Associates

Arlington Heights, Illinois, 60005, United States

Location

Christie Clinic, LLC

Champaign, Illinois, 61820, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Bettencourt Skin Center

Henderson, Nevada, 89074, United States

Location

Union Square Dermatology

New York, New York, 10003, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886

Warwick, Rhode Island, 02886, United States

Location

Greenville Dermatology, LLC

Greenville, South Carolina, 29607, United States

Location

Dermatology Associates of Knoxville, PC

Knoxville, Tennessee, 37917, United States

Location

DermResearch, Inc.Austin

Austin, Texas, 78759, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Director, Clinical R&D
• Organization: Teva Pharmaceuticals Inc., USA

USMedinfo@tevapharm.com

1-888-483-8279

Study Officials

• Oleg Khatsenko, Ph.D

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 13, 2016
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-04

Locations

US (22)