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

LEO Pharma

Status: Completed

Conditions: Actinic Keratosis

Treatments: Drug: Ingenol Mebutate

Study type: Observational

Funder types: Industry

Identifiers

NCT02090465

DE-Picato NIS-2013

Details and patient eligibility

About

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.

Full description

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

Enrollment: 840 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

840 participants in 1 patient group

all eligible patients

Description:

Treatment with Picato according to Summary of Product Characteristics (SmPC)

Treatment:

Drug: Ingenol Mebutate