Prophylactic Photodynamic Therapy to Organ Transplant Patients

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00365521
Collaborator
(none)
50
1

Study Details

Study Description

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 Phase
  • Procedure: Photodynamic Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Study Start Date :
Apr 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Bispebjerg Hospital Copenhagen Copenhagen NV Denmark 2400

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    • Principal Investigator: Merete Hædersdal, MD, PhD, DrMedSci, Bispebjerg Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00365521
    Other Study ID Numbers:
    • KF-01-314759
    First Posted:
    Aug 17, 2006
    Last Update Posted:
    Jun 2, 2008
    Last Verified:
    May 1, 2008

    Study Results

    No Results Posted as of Jun 2, 2008