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NCT01571336 Clinical Trial

Photodynamic Therapy of Actinic Keratoses With Alacare®

Actinic Keratosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01571336
Other study ID # NIS 01
Secondary ID
Status Completed
Phase N/A
First received April 3, 2012
Last updated September 26, 2016
Start date April 2012
Est. completion date September 2016

Study information
Verified date September 2016
Source photonamic GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 388
Est. completion date September 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Medizinisches Zentrum Bonn Friedensplatz Bonn
Germany Hautarztpraxis Prof. Kurzen Freising
Germany Hautärztliche Gemeinschaftspraxis Dr. med. Peter Dworzak Dr. med. Peter Radny Friedrichshafen
Germany Gemeinschaftspraxis Dres.Ina Röhrig-Petering und Holger Petering Hildesheim
Germany Dermatologische Gemeinschaftspraxis Prof. Dr. J. Gille & Dr. K. Spieth-Gille Königstein im Taunus
Germany ZENTderma Mönchengladbach
Germany Facharzt für Haut- und Geschlechtskrankheiten Radolfzell
Germany Praxis Prof. Dr. Thomas Dirschka Wuppertal

Sponsors (1)
Lead Sponsor Collaborator
photonamic GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of SCCs in areas treated with Alacare®-PDT Two years after Alacare®-PDT Yes
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Completed NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A