An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis

NCT03200912 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 094-8152-301
• Study Type: interventional
• Target: 507
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

ACTINIC KERATOSIS

Outcome Measures

Primary Outcomes (1)

• Complete Clearance of AK Lesions

  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

  57 days

Study Arms (3)

Picato

ACTIVE COMPARATOR

Picato® (ingenol mebutate) gel, 0.15% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]

Drug: Ingenol Mebutate (Picato®)

Generic Ingenol Mebutate

EXPERIMENTAL

Generic ingenol mebutate gel, 0.15% \[Test\]

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: RLD

Picato

Generic Ingenol Mebutate DRUG

Generic formulated to have the same therapeutic effect of the brand

Also known as: Test

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 male or non-pregnant female 18 years of age or older.
• Females must have been post-menopausal, surgically sterile, or using an effective method of birth control. Women of childbearing potential (WOCBP) must have had a negative urine pregnancy test (UPT) at Visit 1/Baseline.
• Subject provided written informed consent.
• Subject had a clinical diagnosis of AK at Visit 1/Baseline with at least four, but no more than eight 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") located on the face or scalp.
• 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 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.

You may not qualify if:

• \. Subject was pregnant, lactating, or was planning to become pregnant during the study.
• Subject had a location of the selected contiguous 25 cm2 Treatment Area that (a) was within 5 cm of an incompletely healed wound or (b) was in an area containing a lesion that was previously treated with ingenol mebutate.
• 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 AKs, independent of size, within the selected contiguous 25 cm2 Treatment Area
• Subject had atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, xeroderma pigmentosum, or any other possibly confounding skin conditions within the region of the head that contained the selected Treatment Area (i.e., face or scalp).
• Subject had any skin pathology or condition that, in the investigator's opinion, could have interfered with the evaluation of the test article or required the use of interfering topical, systemic, or surgical therapy.
• Subject was immunosuppressed (e.g., human immunodeficiency virus, systemic malignancy, graft host disease, etc.).
• Subject 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 used topical creams, lotions, or gels of any kind within the selected Treatment Area within one day prior to entry into the study.
• Subject had the need or planned to be exposed to artificial tanning devices or excessive sunlight during the study or had used artificial tanners within two weeks of Visit 1/Baseline.
• Subject had used any of the following topical medications on the face or scalp:
• Corticosteroids within two weeks of Visit 1/Baseline;
• Keratolytic-containing therapeutic products or medicated or irritant topical salves within two weeks of Visit 1/Baseline, including, but not limited to, alpha hydroxy acids (e.g., glycolic acid, lactic acid etc. \>5%), beta hydroxy acid (salicylic acid \>2%), and urea \>5%;
• Topical retinoids (e.g., tazarotene, adapalene, tretinoin) within two weeks of Visit 1/Baseline;
• Light treatments (e.g., psoralen plus ultraviolet A therapy, ultraviolet B) within four weeks of Visit 1/Baseline;

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (23)

Dermatology Specialists, Inc.

Oceanside, California, 92056, United States

Location

Horizons Clinical Research Ctr., LLC

Denver, Colorado, 80220, United States

Location

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Moore Clinical Research

Brandon, Florida, 33511, 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

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Northwest Clinical Trials, Inc.

Boise, Idaho, 83704, United States

Location

Arlington Dermatology

Arlington Heights, Illinois, 60005, United States

Location

Christie Clinic, LLC

Champaign, Illinois, 61820, United States

Location

University Dermatology & Vein Clinic, LLC

Darien, Illinois, 60561, United States

Location

Forefront Dermatology

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

The South Bend Clinic,LLC

South Bend, Indiana, 46617, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

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

Warwick, Rhode Island, 02886, United States

Location

Palmetto Clinical Trial Services

Fountain Inn, South Carolina, 29644, United States

Location

Dermatology Associates of Knoxville, PC

Knoxville, Tennessee, 37917, United States

Location

DermReseach New Braunfels

New Braunfels, Texas, 78130, 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, CE Studies
• Organization: Teva Pharmaceuticals Inc. USA

USMedInfo@tevapharm.com

1-888-483-8259

Study Officials

• Oleg Khatsenko, PhD

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: June 14, 2017
• First Posted: June 27, 2017
• Study Start: August 19, 2016
• Primary Completion: March 7, 2017
• Study Completion: March 22, 2017
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)