Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT00472459
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00472459
Study Brief:
Protocol Section:
NCT00472459