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Completed

NCT Number: NCT02594436

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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Office Based Physician

Athens, Peristeri, 12134, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ingenol Mebutate

Drug

Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling

Other names: Picato

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Acronym: PrAKtice

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2015
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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