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

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ClinicalTrials.gov Identifier: NCT01541553
Recruitment Status : Completed
First Posted : March 1, 2012
Results First Posted : March 28, 2014
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Procedure: Cryotherapy Drug: Vehicle Drug: Ingenol metabute Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
Study Start Date : March 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PEP005 Gel, 0.015%
Cryotherapy followed by PEP005 Gel, 0.015%
 Procedure: Cryotherapy
Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area

Drug: Ingenol metabute
Field treatment with vehicle gel once daily for 3 consecutive days.
Other Name: Picato® gel, 0.015%
Placebo Comparator: Vehicle gel
Cryotherapy followed by vehicle gel
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Complete Clearance of AKs at Week 11 [ Time Frame: 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 :
  1. Percentage Change From Baseline in Number of AKs at Week 11 [ Time Frame: Baseline to week 11 ]
    Percentage change from baseline in number of AKs at Week 11

  2. Partial Clearance of AKs at Week 11 [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541553


Locations
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Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Brian Berman, MD, Ph.D
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01541553    
Other Study ID Numbers: LP0041-21
First Posted: March 1, 2012    Key Record Dates
Results First Posted: March 28, 2014
Last Update Posted: August 30, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms