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

Tracking Information

First Received Date ^ICMJE

August 15, 2006

Last Updated Date

May 30, 2008

Start Date ^ICMJE

April 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00365521 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prophylactic Photodynamic Therapy to Organ Transplant Patients

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Organ Transplants

Intervention ^ICMJE

Procedure: Photodynamic Therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.).

Gender

Both

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Merete Hædersdal, MD, PhD, DrMedSci

+45 35316002

mhaedersdal@dadlnet.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00365521

Other Study ID Numbers ^ICMJE

KF-01-314759

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Bispebjerg Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Merete Hædersdal, MD, PhD, DrMedSci

Bispebjerg Hospital

Information Provided By

Bispebjerg Hospital

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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