Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks
Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Actinic Keratosis
Intervention: Ingenol Mebutate (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: LEO Pharma Official(s) and/or principal investigator(s): Thomas Diepgen, Prof. Dr. med., Principal Investigator, Affiliation: University Hospital Heidelberg
Overall contact: Andreas Gilzinger, Phone: 0049 6102 201-0, Ext: 117, Email: andreas.gilzinger@leo-pharma.com
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.
Clinical Details
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.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Actinic keratosisQuality of life Dosage of Picato®
Detailed description:
Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Andreas Gilzinger, Phone: 0049 6102 201-0, Ext: 117, Email: andreas.gilzinger@leo-pharma.com
Universitätsklinikum Heidelberg/Klinische Sozialmedizin, Heidelberg D-69115, Germany; Recruiting Thomas L. Diepgen, Prof.Dr.med., Phone: +49 6221568751, Email: thomas.diepgen@med.uni-heidelberg.de Thomas L Diepgen, Prof.Dr.med., Principal Investigator
Additional Information
Starting date: July 2013
Last updated: March 17, 2014
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