Photodynamic Therapy of Actinic Keratoses With Alacare®

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

photonamic GmbH & Co. KG

ClinicalTrials.gov Identifier:

NCT01571336

First received: April 3, 2012

Last updated: February 10, 2014

Last verified: February 2014

History of Changes

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:

Genetic and Rare Diseases Information Center resources: Tylosis

U.S. FDA Resources

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:	March 2016
Estimated Primary Completion Date:	November 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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571336

Locations


Germany
Medizinisches Zentrum Bonn Friedensplatz
Bonn, Germany, 53111
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

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:	February 10, 2014
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:


Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases

ClinicalTrials.gov processed this record on March 03, 2015

To Top