Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT00365521 |
Date of registration:
|
15/08/2006 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Prophylactic Photodynamic Therapy to Organ Transplant Patients
|
Scientific title:
|
|
Date of first enrolment:
|
April 2009 |
Target sample size:
|
50 |
Recruitment status: |
Not yet recruiting |
URL:
|
http://clinicaltrials.gov/show/NCT00365521 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Denmark
| | | | | | | |
Contacts
|
Name:
|
Merete Hædersdal, MD, PhD, DrMedSci |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Bispebjerg Hospital |
|
Name:
|
Merete Hædersdal |
Address:
|
|
Telephone:
|
+45 35 31 60 02 |
Email:
|
mhaedersdal@dadlnet.dk |
Affiliation:
|
|
|
Name:
|
Merete Hædersdal, MD, PhD, DrMedSci |
Address:
|
|
Telephone:
|
+45 35316002 |
Email:
|
mhaedersdal@dadlnet.dk |
Affiliation:
|
|
|
Key inclusion & exclusion 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.).
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Organ Transplants
|
Intervention(s)
|
Procedure: Photodynamic Therapy
|
Secondary ID(s)
|
KF-01-314759
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|