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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by LEO Pharma
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT02090465
First received: March 12, 2014
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Actinic Keratosis
Drug: Ingenol Mebutate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Actinic keratosis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato®

  • Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patient' s quality of life during ambulant routine use of Picato®

  • Dosage of Picato® [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Prescribed and applied dosages and adherence during ambulant routine use of Picato®


Estimated Enrollment: 1080
Study Start Date: July 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Picato®

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with actinic keratosis contacting their dermatologist

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02090465

Contacts
Contact: Andreas Gilzinger 0049 6102 201-0 ext 117 andreas.gilzinger@leo-pharma.com

Locations
Germany
Universitätsklinikum Heidelberg/Klinische Sozialmedizin Recruiting
Heidelberg, Germany, D-69115
Contact: Thomas L. Diepgen, Prof.Dr.med.    +49 6221568751    thomas.diepgen@med.uni-heidelberg.de   
Principal Investigator: Thomas L Diepgen, Prof.Dr.med.         
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Thomas Diepgen, Prof. Dr. med. University Hospital Heidelberg
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02090465     History of Changes
Other Study ID Numbers: DE-Picato NIS-2013
Study First Received: March 12, 2014
Last Updated: March 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by LEO Pharma:
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014