Status:
COMPLETED
Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer
Lead Sponsor:
Galderma R&D
Conditions:
Actinic Keratosis
Warts
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2006
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00472459
Start Date
July 25 2003
End Date
July 14 2006
Last Update
April 18 2025
Active Locations (11)
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1
Department of Dermatology, Århus Amysygehus
Aarhus, Denmark, 8000
2
Department of Dermatology, Roskilde Amysygehus
Roskilde, Denmark, 4000
3
Klinik für Dermatologie, Venerologie und Allergologie, Campus Charité Mitte
Berlin, Germany, 10117
4
Hautklinik Linden
Hanover, Germany, 30449