Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Ingenol Mebutate

• Registration Number: NCT02090465
• Lead Sponsor: LEO Pharma

Brief Summary

Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.

Detailed Description

Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

• Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians.

Exclusion Criteria

• Preceding use of Picato® on the area planned for treatment
• Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks
• Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment
• Open wounds on the area planned for treatment
• Contraindications according to prescribing information

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all eligible patients	Ingenol Mebutate	Treatment with Picato according to Summary of Product Characteristics (SmPC)

Primary Outcome Measures

Name	Time	Method
Actinic keratosis	8 weeks	Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato®
Skindex-16	8 weeks	Patient' s quality of life during ambulant routine use of Picato®
Dosage of Picato®	8 weeks	Prescribed and applied dosages and adherence during ambulant routine use of Picato®

Trial Locations

Locations (1)

Universitätsklinikum Heidelberg/Klinische Sozialmedizin; 🇩🇪 Heidelberg, Germany