Photodynamic Therapy of Actinic Keratoses With Alacare®

September 26, 2016 updated by: photonamic GmbH & Co. KG

Non-interventional Observational Study on Photodynamic Therapy of Actinic Keratoses With Alacare®

This study aims to collect data on the frequency of SCCs in the Alacare®-treated area during an interval of two years after Alacare®-PDT.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

388

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
      • Bonn, Germany, 53111
        • Medizinisches Zentrum Bonn Friedensplatz
      • Freising, Germany, 85354
        • Hautarztpraxis Prof. Kurzen
      • Friedrichshafen, Germany, 88045
        • Hautärztliche Gemeinschaftspraxis Dr. med. Peter Dworzak Dr. med. Peter Radny
      • Hildesheim, Germany, 31134
        • Gemeinschaftspraxis Dres.Ina Röhrig-Petering und Holger Petering
      • Königstein im Taunus, Germany, 61462
        • Dermatologische Gemeinschaftspraxis Prof. Dr. J. Gille & Dr. K. Spieth-Gille
      • Mönchengladbach, Germany, 41061
        • ZENTderma
      • Radolfzell, Germany, 78315
        • Facharzt für Haut- und Geschlechtskrankheiten
      • Wuppertal, Germany, 42275
        • Praxis Prof. Dr. Thomas Dirschka

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

Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

  • Written informed consent
  • Patients with 3 to 6 mild AK lesions on the hairless areas of the head and face which were treated with Alacare®-PDT according to the SPC

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of SCCs in areas treated with Alacare®-PDT
Time Frame: Two years after Alacare®-PDT
Two years after Alacare®-PDT

Collaborators and Investigators

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

Sponsor

photonamic GmbH & Co. KG

Investigators

  • Study Chair: Peter Radny, MD, Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany

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

April 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS 01

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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