A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

Completed · Phase 3

Conditions studied: Actinic Keratosis

In brief

The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.

Key facts

Study ID

NCT01541553

Run by

LEO Pharma

People needed

367

Starts

2012-03-01

Expected to finish

2013-07-01

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be competent to understand the nature of the trial and provide informed consent.
• 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.

You may not qualify if…

• Location of the selected treatment area:
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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