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Photodynamic Therapy of Actinic Keratoses With Alacare®

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ClinicalTrials.gov Identifier: NCT01571336
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
photonamic GmbH & Co. KG

Brief Summary:
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 or disease
Actinic Keratosis

Study Type : Observational
Actual Enrollment : 388 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-interventional Observational Study on Photodynamic Therapy of Actinic Keratoses With Alacare®
Study Start Date : April 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


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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

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

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

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