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

Phase 3

Completed

Conditions: Actinic Keratosis

Interventions: Procedure: Cryotherapy
Drug: Vehicle
Drug: Ingenol metabute

Registration Number: NCT01541553

Lead Sponsor: LEO Pharma

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 367

Inclusion Criteria

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.

Exclusion Criteria

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).

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP005 Gel, 0.015%	Cryotherapy	Cryotherapy followed by PEP005 Gel, 0.015%
Vehicle gel	Cryotherapy	Cryotherapy followed by vehicle gel
Vehicle gel	Vehicle	Cryotherapy followed by vehicle gel
PEP005 Gel, 0.015%	Ingenol metabute	Cryotherapy followed by PEP005 Gel, 0.015%

Primary Outcome Measures

Name	Time	Method
Complete Clearance of AKs at Week 11	11 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Number of AKs at Week 11	Baseline to week 11	Percentage change from baseline in number of AKs at Week 11
Partial Clearance of AKs at Week 11	Week 11	Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11

Trial Locations

Locations (35): Long Island Skin Cancer and Dermatologic Surgery
🇺🇸
Smithtown, New York, United States
Center for Dermatology Clinical Research
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Fremont, California, United States
Dermatology Specialists, Inc.
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Oceanside, California, United States
Skin Surgery Medical Group, Inc.
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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
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Aventura, Florida, United States
Study Protocol, Inc.
🇺🇸
Boynton Beach, Florida, United States
North Florida Dermatology Associates, PA
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Jacksonville, Florida, United States
University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare
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Tampa, Florida, United States
MedaPhase
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Newnan, Georgia, United States
Gwinnett Clinical Research Center, Inc.
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Snellville, Georgia, United States
Altman Dermatology Associates
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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
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Albuquerque, New Mexico, United States
Mount Sinai School of Medicine
🇺🇸
New York, New York, United States
Skin Search of Rochester, Inc.
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Rochester, 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
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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