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Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer

NCT00472459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-04-18

Study results available
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Summary

Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC (Basal Cell Carcinoma), increased with graft survival time and the length of immunosuppressive treatment period.

The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicated the need for early removal of these pre-malignant lesions.

In this study, two contralateral areas (5x10 cm\^2) with skin lesions within the participant were compared. One area was received Metvix PDT at defined intervals and the other was received lesion specific treatment at the discretion of the investigator. The primary endpoint was the accumulated number of new lesions during the study and number of AK lesions that showed complete response 3 months after baseline. Secondary endpoints were number of BCC lesions that showed complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.

Conditions

Interventions

PROCEDURE

Photodynamic therapy with Metvix 160 mg/g cream

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Ann-Marie Wennberg, MD, PhD · Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-25
Primary Completion
2004-09-23
Completion
2006-07-14

Countries

  • Denmark
  • Germany
  • Norway
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00472459 on ClinicalTrials.gov