NCT00365521

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
Last Updated

June 2, 2008

Status Verified

May 1, 2008

First QC Date

August 15, 2006

Last Update Submit

May 30, 2008

Conditions

Organ Transplants

Keywords

Organ transplant patients receiving immunosuppressive therapy

Interventions

Photodynamic TherapyPROCEDURE

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Organ transplant recipients.
  • Age 40 years or older.

You may not qualify if:

  • Patients younger than 40 years and older than 70 years.
  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Interventions

Photochemotherapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Merete Hædersdal, MD, PhD, DrMedSci

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Merete Hædersdal, MD, PhD, DrMedSci

CONTACT

+45 35316002mhaedersdal@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

April 1, 2009

Last Updated

June 2, 2008

Record last verified: 2008-05

Locations

DK(1)