Prophylactic Photodynamic Therapy to Organ Transplant Patients

Organ Transplants Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00365521
• Other study ID #: KF-01-314759
• Status: Not yet recruiting
• Phase: N/A
• First received: August 15, 2006
• Last updated: May 30, 2008
• Start date: April 2009

Study information

• Verified date: May 2008
• Source: Bispebjerg Hospital
• Contact: Merete Hædersdal, MD, PhD, DrMedSci
• Phone: +45 35316002
• Email: mhaedersdal[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.).

Study Design

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

Related Conditions & MeSH terms

• Organ Transplants

Intervention

Procedure:
• Photodynamic Therapy

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark,