A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
1 other identifier
interventional
367
1 country
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
March 1, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
March 28, 2014
CompletedMarch 10, 2025
July 1, 2016
1.3 years
February 17, 2012
February 13, 2014
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Clearance of AKs at Week 11
To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
11 weeks
Secondary Outcomes (2)
Percentage Change From Baseline in Number of AKs at Week 11
Baseline to week 11
Partial Clearance of AKs at Week 11
Week 11
Study Arms (2)
PEP005 Gel, 0.015%
ACTIVE COMPARATORCryotherapy followed by PEP005 Gel, 0.015%
Vehicle gel
PLACEBO COMPARATORCryotherapy followed by vehicle gel
Interventions
Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area
Field treatment with vehicle gel once daily for 3 consecutive days.
Eligibility Criteria
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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (35)
Center for Dermatology Clinical Research
Fremont, California, 94538, United States
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
Skin Surgery Medical Group, Inc.
San Diego, California, 92117, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210, United States
About Skin Dermatology and DermSurgery, PC
Englewood, Colorado, 80113, United States
The Center for Clincial and Cosmetic Research
Aventura, Florida, 33180, United States
Study Protocol, Inc.
Boynton Beach, Florida, 33437, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204, United States
University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, 33612, United States
MedaPhase
Newnan, Georgia, 30263, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, 46032, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Great Lakes Research Center
Bay City, Michigan, 48706, United States
Henry Ford Medical Centre - New Center One, Department of Dermatology
Detroit, Michigan, 48202, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Skin Search of Rochester, Inc.
Rochester, New York, 14623, United States
Long Island Skin Cancer and Dermatologic Surgery
Smithtown, New York, 11787, United States
Oregon Medical Research Center, PC
Portland, Oregon, 97223, United States
Oregon Health & Science University, Dept. of Dermatology
Portland, Oregon, 97239-6483, United States
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034, United States
Dermatology Research Associates, Inc.
Nashville, Tennessee, 37203, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
Suzanne Bruce and Associates, P.A.
Houston, Texas, 77056, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
Related Publications (2)
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.
PMID: 24918567DERIVEDBerman 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.
PMID: 24509965DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical trial disclosure
- Organization
- LEO Pharma A/S
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Berman, MD, Ph.D
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2012
First Posted
March 1, 2012
Study Start
March 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 10, 2025
Results First Posted
March 28, 2014
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share