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Prophylactic Photodynamic Therapy to Organ Transplant Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Bispebjerg Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00365521
First received: August 15, 2006
Last updated: May 30, 2008
Last verified: May 2008
History of Changes
  Purpose

To evaluate a possible prophylactic efficacy of photodynamic therapy on the incidence of non-melanoma skin cancer, actinic keratoses, warts and keratoses in recently organ transplanted recipients.


Condition Intervention
Organ Transplants
 Procedure: Photodynamic Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind

Further study details as provided by Bispebjerg Hospital:

Estimated Enrollment: 50
Study Start Date: April 2009
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Organ transplant recipients.
  • Age 40 years or older.

Exclusion Criteria:

  • Patients younger than 40 years and older than 70 years.
  • Clinical signs of skin cancer, actinic keratoses or warts at the time of inclusion.
  • Previous photodynamic therapy to the skin areas investigated.
  • Pregnancy or breast feeding patients.
  • Patients with porphyria.
  • Patients with a tendency to produce hypertrophic scars or keloids.
  • Patients with known allergy to Metvix.
  • Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients etc.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365521

Contacts
Contact: Merete Hædersdal, MD, PhD, DrMedSci +45 35316002 mhaedersdal@dadlnet.dk

Locations
Denmark
Bispebjerg Hospital Not yet recruiting
Copenhagen, Copenhagen NV, Denmark, 2400
Contact: Merete Hædersdal     +45 35 31 60 02     mhaedersdal@dadlnet.dk    
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Merete Hædersdal, MD, PhD, DrMedSci Bispebjerg Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00365521     History of Changes
Other Study ID Numbers: KF-01-314759
Study First Received: August 15, 2006
Last Updated: May 30, 2008
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by Bispebjerg Hospital:
Organ transplant patients receiving immunosuppressive therapy

ClinicalTrials.gov processed this record on May 19, 2013