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
  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:


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
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
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 14, 2014