Clinical trial NCT01541553: A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
Official title: A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete Clearance of AKs at Week 11
timeFrame: 11 weeks
Secondary outcomes:
measure: Percentage Change From Baseline in Number of AKs at Week 11
timeFrame: Baseline to week 11
measure: Partial Clearance of AKs at Week 11
timeFrame: Week 11
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc.
state: Colorado
city: Englewood
country: United States
facility: About Skin Dermatology and DermSurgery, PC
state: Colorado
city: Aventura
country: United States
facility: The Center for Clincial and Cosmetic Research
state: Florida
city: Boynton Beach
country: United States
facility: Study Protocol, Inc.
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare
state: Florida
city: Newnan
country: United States
facility: MedaPhase
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Bay City
country: United States
facility: Great Lakes Research Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Centre - New Center One, Department of Dermatology
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Smithtown
country: United States
facility: Long Island Skin Cancer and Dermatologic Surgery
state: New York
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University, Dept. of Dermatology
state: Oregon
city: Fort Washington
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Nashville
country: United States
facility: Dermatology Research Associates, Inc.
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
name: Brian Berman, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.