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The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice (PrAKtice)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02594436
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
This is a prospective, non-interventional study of adult patients prescribed topical treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete clearance at 8 weeks will be followed for one year or until retreatment of AK in the area initially treated, whatever comes first. For patients with incomplete clearance in the treated area at 8 weeks the treatment strategy for this area will be recorded but no further follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction and health-related quality of life (HRQoL) associated with Picato® treatment will be evaluated.

Condition or disease Intervention/treatment
Actinic Keratosis Drug: Ingenol mebutate

Detailed Description:

Actinic Keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to progress to squamous cell carcinoma. Ingenol mebutate gel is a relatively new topical treatment option for AK in Greece.

Taking into consideration the limited real-world evidence that is attributed to the recent advent of Picato in the Greek market, this non-interventional observational study aims primarily at assessing the characteristics of patients selected for this treatment, the effectiveness and tolerability of the treatment, patient satisfaction and the impact of the therapy on patients' HRQoL in standard clinical practice.The study will be carried out by approximately 30 physicians practicing in private or public hospitals and clinics in representative geographical regions of Greece.

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Study Type : Observational
Actual Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice: A Prospective Phase IV, Multicentre, Pan-Hellenic Observational Cohort Study
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ingenol mebutate gel 0.015 percent
Topical treatment of face or scalp once daily for three consecutive days
Drug: Ingenol mebutate
Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling
Other Name: Picato

Ingenol mebutate gel 0.05 percent
Topical treatment of trunk or extremities once daily for two consecutive days
Drug: Ingenol mebutate
Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling
Other Name: Picato




Primary Outcome Measures :
  1. Rate of complete clearance [ Time Frame: Around 8 weeks post treatment ]
    Percentage of patients with no clinically visible remaining lesions in treated area

  2. Lesion count reduction [ Time Frame: Around 8 weeks post treatment ]
    Reduction in number of clinically visible lesions in treated area compared to baseline count.


Secondary Outcome Measures :
  1. Remission rate for patients with complete initial clearance [ Time Frame: 12 months ]
    Proportion of patients without known recurrence of AK lesions in treated area for patients with complete initial clearance

  2. Patient satisfaction with treatment [ Time Frame: Around 8 weeks post treatment ]
    Patient reported satisfaction with treatment as measured by the domains of effectiveness, convenience and global satisfaction of TSQM-9 (Treatment Satisfaction Questionnaire of Medication)

  3. Health Related Quality of Life EQ-5D-5L [ Time Frame: Baseline and around 8 weeks post treatment ]
    EQ-5D-5L is a standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents. It consists of two pages comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients planned for starting treatment non-hyperkeratotic, non-hypertrophic actinic keratosis on face, scalp, trunk or extremities with topical ingenol mebutate gel.
Criteria

Inclusion Criteria:

  • Planned to receive topical ingenol mebutate gel for treatment of Actinic Keratosis according to current labelling in Greece.
  • Written informed consent obtained to use the patient's data for the study.

Exclusion Criteria:

  • Contraindications according to prescribing information.
  • Previous treatment with PICATO in the selected treatment area.

Information from the National Library of Medicine

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): NCT02594436


Locations
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Greece
Office Based Physician
Athens, Peristeri, Greece, 12134
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Kostas Sitaras, MD LEO Pharma Hellas SA
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02594436    
Other Study ID Numbers: NIS-PICATO-1220
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Keywords provided by LEO Pharma:
Actinic Keratosis
topical
ingenol mebutate
Picato®
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms