Photodynamic Therapy of Actinic Keratoses With Alacare®
|
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. |
| ClinicalTrials.gov Identifier: NCT01571336 |
|
Recruitment Status
:
Completed
First Posted
: April 5, 2012
Last Update Posted
: September 27, 2016
|
Sponsor:
photonamic GmbH & Co. KG
Information provided by (Responsible Party):
photonamic GmbH & Co. KG
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Primary Outcome Measures
:
- Number of SCCs in areas treated with Alacare®-PDT [ Time Frame: Two years after Alacare®-PDT ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |