A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
NCT ID: NCT01541553
Last Updated: 2025-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
367 participants
INTERVENTIONAL
2012-03-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PEP005 Gel, 0.015%
Cryotherapy followed by PEP005 Gel, 0.015%
Cryotherapy
Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area
Ingenol metabute
Field treatment with vehicle gel once daily for 3 consecutive days.
Vehicle gel
Cryotherapy followed by vehicle gel
Cryotherapy
Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area
Vehicle
Field treatment with vehicle gel once daily for 3 consecutive days.
Interventions
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Cryotherapy
Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area
Vehicle
Field treatment with vehicle gel once daily for 3 consecutive days.
Ingenol metabute
Field treatment with vehicle gel once daily for 3 consecutive days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp.
* Subject at least 18 years of age.
* Female subjects must be of either:
* Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
* Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy.
* Female subjects of childbearing potential must be willing to use effective contraception.
Exclusion Criteria
* on any location other than the face or scalp
* within 5 cm of an incompletely healed wound
* within 10 cm of a suspected basal cell carcinoma (BCC) or SCC
* Prior treatment with PEP005 Gel on face or scalp.
* Selected treatment area lesions that have:
* atypical clinical appearance and/or
* recalcitrant disease
* History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication
* Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy.
* Any abnormal vital signs measurements that are medically significant or would impact the safety of the subject or the interpretation of the trial results.
* Anticipated need for hospitalization or out-patient surgery during the first 15 days after the first trial medication application.
* Known sensitivity or allergy to any of the ingredients in PEP005 Gel
* Recent excessive exposure to ultraviolet light
* Current enrolment or participation in a clinical trial within 30 days of entry into this study
* Subjects previously randomised in the trial
* Female subjects who are breastfeeding
Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1
* Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
* Use of acid-containing therapeutic products within 2 cm of the selected treatment area
* Use of topical medicated creams, ointments, lotions, gels, foams or sprays
Prohibited Therapies and/or Medications: within 4 weeks prior to visit 1:
* Treatment with immunomodulators, cytotoxic drugs or inter-feron /interferon inducers
* Treatment with systemic medications that suppress the immune system
* Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB).
Prohibited Therapies and/or Medications within 8 weeks prior to visit 1:
* Treatment with 5-FU, imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area.
Prohibited Therapies and/or Medications within 6 months prior to visit 1
* Use of systemic retinoids or biologic / mono-clonal antibody therapies
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Berman, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Locations
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Center for Dermatology Clinical Research
Fremont, California, United States
Dermatology Specialists, Inc.
Oceanside, California, United States
Skin Surgery Medical Group, Inc.
San Diego, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Colorado Medical Research Center, Inc.
Denver, Colorado, United States
About Skin Dermatology and DermSurgery, PC
Englewood, Colorado, United States
The Center for Clincial and Cosmetic Research
Aventura, Florida, United States
Study Protocol, Inc.
Boynton Beach, Florida, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States
University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States
MedaPhase
Newnan, Georgia, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Great Lakes Research Center
Bay City, Michigan, United States
Henry Ford Medical Centre - New Center One, Department of Dermatology
Detroit, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Mount Sinai School of Medicine
New York, New York, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Long Island Skin Cancer and Dermatologic Surgery
Smithtown, New York, United States
Oregon Medical Research Center, PC
Portland, Oregon, United States
Oregon Health & Science University, Dept. of Dermatology
Portland, Oregon, United States
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States
Dermatology Research Associates, Inc.
Nashville, Tennessee, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Suzanne Bruce and Associates, P.A.
Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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References
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Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM, Larsson T, Swanson N. Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis: 12-month results. J Drugs Dermatol. 2014 Jun;13(6):741-7.
Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM, Goncalves J, Larsson T, Skov T, Swanson N. Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-week results. J Drugs Dermatol. 2014 Feb;13(2):154-60.
Related Links
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Clinical Trials at LEO Pharma
Other Identifiers
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LP0041-21
Identifier Type: -
Identifier Source: org_study_id
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