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

December 13, 2019 updated by: LEO Pharma

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

840

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, D-69115
        • Universitätsklinikum Heidelberg/Klinische Sozialmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with actinic keratosis contacting their dermatologist

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all eligible patients
Treatment with Picato according to Summary of Product Characteristics (SmPC)
Drug: Ingenol Mebutate
No intervention: observation of routine use of Picato®
Other Names:
  • Picato®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Thomas Diepgen, Prof. Dr. med., University Hospital Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE-Picato NIS-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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