Photodynamic Therapy of Actinic Keratoses With Alacare®
This study is currently recruiting participants.
Verified April 2012 by photonamic GmbH & Co. KG
Sponsor:
photonamic GmbH & Co. KG
Information provided by (Responsible Party):
photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01571336
First received: April 3, 2012
Last updated: April 26, 2012
Last verified: April 2012
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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® |
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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 420 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571336
Contacts
| Contact: Andrea Ebeling, PhD | a.ebeling@photonamic.de | |
| Contact: Marcus Stocker, PhD | m.stocker@photonamic.de |
Locations
| Germany | |
| Medizinisches Zentrum Bonn Friedensplatz | Recruiting |
| Bonn, Germany, 53111 | |
| Principal Investigator: Uwe Reinhold, Prof. Dr. | |
| Hautärztliche Gemeinschaftspraxis Dr. med. Peter Dworzak Dr. med. Peter Radny | Recruiting |
| Friedrichshafen, Germany, 88045 | |
| Principal Investigator: Peter Radny, MD | |
| Gemeinschaftspraxis Dres.Ina Röhrig-Petering und Holger Petering | Recruiting |
| Hildesheim, Germany, 31134 | |
| Principal Investigator: Holger Petering, PD Dr. | |
| Dermatologische Gemeinschaftspraxis Prof. Dr. J. Gille & Dr. K. Spieth-Gille | Recruiting |
| Königstein im Taunus, Germany, 61462 | |
| Principal Investigator: Jens Gille, Prof. Dr. | |
| ZENTderma | Recruiting |
| Mönchengladbach, Germany, 41061 | |
| Principal Investigator: Rolf Ostendorf, MD | |
| Facharzt für Haut- und Geschlechtskrankheiten | Recruiting |
| Radolfzell, Germany, 78315 | |
| Principal Investigator: Andras Rozsondai, MD | |
| Praxis Prof. Dr. Thomas Dirschka | Recruiting |
| Wuppertal, Germany, 42275 | |
| Principal Investigator: Thomas Dirschka, Prof. Dr. | |
Sponsors and Collaborators
photonamic GmbH & Co. KG
Investigators
| Study Chair: | Peter Radny, MD | Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany |
More Information
No publications provided
| Responsible Party: | photonamic GmbH & Co. KG |
| ClinicalTrials.gov Identifier: | NCT01571336 History of Changes |
| Other Study ID Numbers: | NIS 01 |
| Study First Received: | April 3, 2012 |
| Last Updated: | April 26, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013