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

Actinic Keratosis Clinical Trial

— PrAKtice  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594436
• Other study ID #: NIS-PICATO-1220
• Status: Completed
• Start date: December 1, 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

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

Locations

Country	Name	City	State
Greece	Office Based Physician	Athens	Peristeri

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete clearance	Percentage of patients with no clinically visible remaining lesions in treated area	Around 8 weeks post treatment
Primary	Lesion count reduction	Reduction in number of clinically visible lesions in treated area compared to baseline count.	Around 8 weeks post treatment
Secondary	Remission rate for patients with complete initial clearance	Proportion of patients without known recurrence of AK lesions in treated area for patients with complete initial clearance	12 months
Secondary	Patient satisfaction with 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)	Around 8 weeks post treatment
Secondary	Health Related Quality of Life EQ-5D-5L	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.	Baseline and around 8 weeks post treatment

External Links

•   Poster with study results