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

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541553
• Other study ID #: LP0041-21
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2012
• Last updated: February 13, 2014
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Procedure:
• Cryotherapy
Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area

Drug:
• 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.

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	The Center for Clincial and Cosmetic Research	Aventura	Florida
United States	Great Lakes Research Center	Bay City	Michigan
United States	Study Protocol, Inc.	Boynton Beach	Florida
United States	Laser & Skin Surgery Center of Indiana	Carmel	Indiana
United States	Colorado Medical Research Center, Inc.	Denver	Colorado
United States	Henry Ford Medical Centre - New Center One, Department of Dermatology	Detroit	Michigan
United States	About Skin Dermatology and DermSurgery, PC	Englewood	Colorado
United States	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania
United States	Center for Dermatology Clinical Research	Freemont	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Suzanne Bruce and Associates, P.A.	Houston	Texas
United States	North Florida Dermatology Associates, PA	Jacksonville	Florida
United States	The Education & Research Foundation, Inc.	Lynchburg	Virginia
United States	Dermatology Research Associates, Inc.	Nashville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	MedaPhase	Newnan	Georgia
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	Oregon Health & Science University, Dept. of Dermatology	Portland	Oregon
United States	Oregon Medical Research Center, PC	Portland	Oregon
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Skin Surgery Medical Group, Inc.	San Diego	California
United States	University Clinical Trials, Inc.	San Diego	California
United States	Long Island Skin Cancer and Dermatologic Surgery	Smithtown	New York
United States	Gwinnett Clinical Research Center, Inc.	Snellville	Georgia
United States	Premier Clinical Research	Spokane	Washington
United States	University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare	Tampa	Florida
United States	Grekin Skin Institute	Warren	Michigan
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage Reduction From Baseline in Number of AKs at Week 11	Percentage reduction from baseline in number of AKs at Week 11	Baseline to week 11	No
Secondary	Partial Clearance of AKs at 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	Week 11	No