A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% 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, 0.05% 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.

Key facts

Study ID

NCT02654769

Run by

Actavis Inc.

People needed

441

Starts

2015-02-01

Expected to finish

2015-09-01

Last updated by the study team

2020-05-12

Who can join

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

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).
• 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.

Where it is running

• Center for Dermatology Clinical Research, Inc — Fremont, California, United States
• SD Sports Medicine & Family Health Center — San Diego, California, United States
• The Center for Clinical and Cosmetic Research — Aventura, 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
• Moore Clinical Research, Inc. — Tampa, Florida, United States
• Northwest Clinical Trials, Inc. — Boise, Idaho, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Christie Clinic, LLC — Champaign, Illinois, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Bettencourt Skin Center — Henderson, Nevada, United States
• Union Square Dermatology — New York, New York, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• PMG Research of Winston-Salem, LLC — Winston-Salem, North Carolina, United States
• Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886 — Warwick, Rhode Island, United States
• Greenville Dermatology, LLC — Greenville, South Carolina, United States
• Dermatology Associates of Knoxville, PC — Knoxville, Tennessee, United States
• DermResearch, Inc.Austin — Austin, Texas, United States
• The Center for Skin Research — Houston, Texas, United States
• Virginia Clinical Research — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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