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

Launched by GALDERMA R&D · May 10, 2007

Keywords

ClinConnect Summary

The treatment area (5x10 cm\^2) was treated at baseline and at 3 ,9 and 15 months visits. At baseline, the area was treated with fractionated Metvix® PDT treatment consisting of two treatment one week apart and at 3 ,9 and 15 months visits with single Metvix® PDT treatment. The participants were evaluated for occurrence of new lesions, lesion response and recurrence at 3 (not recurrence),9,15,21, and 27 months visits. New and recurrent lesions in the treated area were treated with Metvix® PDT treatment. Lesions with partial response in the treated area were re-treated with Metvix® PDT and l...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Transplant recipients with at least 2 clinically diagnosed AK lesion and maximum 10 skin lesions (AK, BCC, SCC in situ and/or warts) in each of the two contralateral areas (diameter 5x10\^2 cm) in the face, the scalp, the extremities or on the trunk/neck.
• • Transplant recipients who previously were treated more than once for their skin lesions.
• • Transplant recipients who had received immunosuppressive therapy for more than 3 years.
• • Males or females above 18 years of age.
• • Written informed consent.
• Exclusion Criteria:
• • Participants with more than 10 skin lesions (AK, BCC, SCC in situ, warts) in one of the two areas.
• • Participants with SCC (not SCC in situ) in one of the two areas.
• • Participants not previously treated or treated only once for their skin lesions.
• • Participants with rosacea in one of the two areas.
• • Participants with morphea form/highly infiltrating BCC
• • Known allergy to methyl-amino levulinate, a similar compound or excipients of the cream
• • Participation in other clinical studies either concurrently or within the last 30 days.
• • Pregnant or breast-feeding (all women of child-bearing potential documented a negative pregnancy test and used the pill or IUD during the treatments and for at least one month thereafter).
• • Conditions associated with a risk of poor protocol compliance