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Prophylactic Photodynamic Therapy to Organ Transplant Patients

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ClinicalTrials.gov Identifier: NCT00365521
Recruitment Status : Unknown
Verified May 2008 by Bispebjerg Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2006
Last Update Posted : June 2, 2008
Sponsor:
Information provided by:
Bispebjerg Hospital

Brief Summary:
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 or disease Intervention/treatment
Organ Transplants Procedure: Photodynamic Therapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Study Start Date : April 2009




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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.).

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): 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

ClinicalTrials.gov Identifier: NCT00365521     History of Changes
Other Study ID Numbers: KF-01-314759
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: June 2, 2008
Last Verified: May 2008

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