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

N/ACompletedNCT02090465

LEO Pharma840 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

840

Conditions

Actinic Keratosis

Interventions

Ingenol MebutateDRUG

No intervention: observation of routine use of Picato®

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Heidelberg/Klinische Sozialmedizin

Heidelberg, Germany

Outcomes

Primary Outcomes

Actinic keratosis

Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato®

Time frame: 8 weeks

Skindex-16

Patient' s quality of life during ambulant routine use of Picato®

Time frame: 8 weeks

Dosage of Picato®

Prescribed and applied dosages and adherence during ambulant routine use of Picato®

Time frame: 8 weeks

Data from ClinicalTrials.gov

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