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

NCT02594436 | Completed

• 1 other identifier: NIS-PICATO-1220
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; topical; ingenol mebutate; Picato®

Outcome Measures

Primary Outcomes (2)

• Rate of complete clearance

  Percentage of patients with no clinically visible remaining lesions in treated area

  Around 8 weeks post treatment

• Lesion count reduction

  Reduction in number of clinically visible lesions in treated area compared to baseline count.

  Around 8 weeks post treatment

Secondary Outcomes (3)

• Remission rate for patients with complete initial clearance

  12 months

• Patient satisfaction with treatment

  Around 8 weeks post treatment

• Health Related Quality of Life EQ-5D-5L

  Baseline and around 8 weeks post treatment

Study Arms (2)

Ingenol mebutate gel 0.015 percent

Topical treatment of face or scalp once daily for three consecutive days

Drug: Ingenol mebutate

Ingenol mebutate gel 0.05 percent

Topical treatment of trunk or extremities once daily for two consecutive days

Drug: Ingenol mebutate

Interventions

Ingenol mebutate DRUG

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

Also known as: Picato

Ingenol mebutate gel 0.015 percent; Ingenol mebutate gel 0.05 percent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Office Based Physician

Athens, Peristeri, 12134, Greece

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kostas Sitaras, MD

  LEO Pharma Hellas SA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 3, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

GR (1)