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

Completed · Phase 3 · Has a placebo group

Conditions studied: ACTINIC KERATOSIS

In brief

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.

Key facts

Study ID

NCT03200912

Run by

Actavis Inc.

People needed

507

Starts

2016-08-19

Expected to finish

2017-03-22

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

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…

• 1. 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;
• Photodynamic therapy within eight weeks of Visit 1/Baseline;
• 5-fluorouracil, diclofenac, imiquimod, or ingenol mebutate within eight weeks of Visit 1/Baseline; or
• Other topical therapy for actinic keratosis within 2 cm of the selected contiguous 25 cm2 Treatment Area within eight weeks of Visit 1/Baseline.
• Subject had cryodestruction or chemodestruction, surgical excision, curettage, dermabrasion, chemical peel, or laser resurfacing on the Treatment Area (i.e., face or scalp) within two weeks prior to Visit 1/Baseline.
• Subject used any of the following systemic medications:
• Corticosteroid therapy within one month;
• Interferon/interferon inducers, cytotoxic drugs, immuno-modulators, or immunosuppressive therapies within one month;
• Retinoid therapy within six months prior to Visit 1/Baseline.
• Subject had lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected contiguous 25 cm2 Treatment Area on the face or scalp.
• Subject was enrolled in an investigational drug or device study.

Where it is running

• Dermatology Specialists, Inc. — Oceanside, California, United States
• Horizons Clinical Research Ctr., LLC — Denver, Colorado, United States
• The Center for Clinical and Cosmetic Research — Aventura, Florida, United States
• Moore Clinical Research — Brandon, Florida, United States
• Savin Medical Group Research Center — Miami Lakes, Florida, United States
• Tory P. Sullivan, M.D., P.A. — North Miami Beach, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Northwest Clinical Trials, Inc. — Boise, Idaho, United States
• Arlington Dermatology — Arlington Heights, Illinois, United States
• Christie Clinic, LLC — Champaign, Illinois, United States
• University Dermatology & Vein Clinic, LLC — Darien, Illinois, United States
• Forefront Dermatology — Carmel, Indiana, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• The South Bend Clinic,LLC — South Bend, Indiana, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886 — Warwick, Rhode Island, United States
• Palmetto Clinical Trial Services — Fountain Inn, South Carolina, United States
• Dermatology Associates of Knoxville, PC — Knoxville, Tennessee, United States
• DermReseach New Braunfels — New Braunfels, Texas, United States

Full record on ClinicalTrials.gov

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