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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 keratosis

Quality 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

Page last updated: August 23, 2015

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