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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Accumulated New Skin Lesions at Month 3
Timeframe: At Month 3
2
Number of Accumulated New Skin Lesions at Month 9
Timeframe: At Month 9
3
Number of Accumulated New Skin Lesions at Month 15
Timeframe: At Month 15
4
Number of Accumulated New Skin Lesions at Month 21
Timeframe: At Month 21
5
Number of Accumulated New Skin Lesions at Month 27
Timeframe: At Month 27
6
Number of AK Lesions That Showed Complete Response at Month 3
Timeframe: At Month 3
7
Number of AK Lesions That Showed Complete Response at Month 9