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Photodynamic Therapy of Actinic Keratoses With Alacare®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571336
First Posted: April 5, 2012
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
photonamic GmbH & Co. KG
  Purpose
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.

Condition
Actinic Keratosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-interventional Observational Study on Photodynamic Therapy of Actinic Keratoses With Alacare®

Resource links provided by NLM:


Further study details as provided by photonamic GmbH & Co. KG:

Primary Outcome Measures:
  • Number of SCCs in areas treated with Alacare®-PDT [ Time Frame: Two years after Alacare®-PDT ]

Enrollment: 388
Study Start Date: April 2012
Study Completion Date: September 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community sample
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571336


Locations
Germany
Medizinisches Zentrum Bonn Friedensplatz
Bonn, Germany, 53111
Hautarztpraxis Prof. Kurzen
Freising, Germany, 85354
Hautärztliche Gemeinschaftspraxis Dr. med. Peter Dworzak Dr. med. Peter Radny
Friedrichshafen, Germany, 88045
Gemeinschaftspraxis Dres.Ina Röhrig-Petering und Holger Petering
Hildesheim, Germany, 31134
Dermatologische Gemeinschaftspraxis Prof. Dr. J. Gille & Dr. K. Spieth-Gille
Königstein im Taunus, Germany, 61462
ZENTderma
Mönchengladbach, Germany, 41061
Facharzt für Haut- und Geschlechtskrankheiten
Radolfzell, Germany, 78315
Praxis Prof. Dr. Thomas Dirschka
Wuppertal, Germany, 42275
Sponsors and Collaborators
photonamic GmbH & Co. KG
Investigators
Study Chair: Peter Radny, MD Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany
  More Information

Responsible Party: photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01571336     History of Changes
Other Study ID Numbers: NIS 01
First Submitted: April 3, 2012
First Posted: April 5, 2012
Last Update Posted: September 27, 2016
Last Verified: September 2016

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