|- candidate number||14656|
|- NTR Number||NTR3930|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-apr-2013|
|- Secondary IDs||NL39975.078.12 CCMO|
|- Public Title||The management of actinic keratosis in transplant recipients.|
|- Scientific Title||The management of actinic keratosis in transplant recipients.|
|- Healt Condition(s) or Problem(s) studied||Patient preferences, Transplantation, Imiquimod, 5-Fluorouracil, Actinic keratosis, Photodynamic therapy|
|- Inclusion criteria||1. Adults (above the age of 18 years old);|
2. Solid organ transplant recipients (heart, lung, kidney and liver) under stable immunosuppressive treatment since 6 months;
3. Informed consent signed;
4. More than 5 mild to moderate AK (clinical diagnosis) on both dorsal hands with symmetrical involvement in term of severity and number.
|- Exclusion criteria||1. A treatment for AK on the dorsal hand in the last 3 months;|
2. Taking oral retinoid within 4 weeks before enrolment;
3. Pregnancy or breastfeeding during the study;
4. A proven allergy for one of the used products in the study;
5. Other skin disease including invasive SCC on the dorsa of the hand; in doubt histology will be performed.
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2013|
|- planned closingdate||1-jan-2015|
|- Target number of participants||60|
|- Interventions||Left/right MAL-PDT and left/right respectively topical treatment.|
|- Primary outcome||Patients preference.|
|- Secondary outcome||1. Cosmetic outcome;|
|- Timepoints||After inclusion (day 1), patients will be seen at:|
Day 1: Start IMQ or 5-FU on one hand and MAL-PDT on the other hand;
Week 1: 2nd session PDT on the hand randomized in MAL-PDT treatment;
Week 3: A conference call to make sure a good compliance is achieved;
Week 12: Evaluations and end of the study.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. H.A.M. Neumann|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.A.M. Neumann|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Dermatology and Venereology|
(Source(s) of Monetary or Material Support)
|- Brief summary||Objective: |
To determine patientís preference between MAL-PDT and 5-FU and IMQ next to study treatment efficacy, safety and investigators preference of treatments.
A randomized monocentric controlled single-blinded study.
Solid organ transplant recipients aged 18 years and older which have > 5 mild to moderate AKs on the dorsa of both hands.
2 groups of 30 patients: Methyl aminolevulinate PDT (MAL-PDT) versus 5-FU and Methyl aminolevulinate PDT (MAL-PDT) versus IMQ.
Main study parameters/endpoints:
Primary parameter will be patientís preference between treatment with MAL-PDT, IMQ or 5-FU.
Secondary parameters are efficacy, safety (clinical skin appearance, adverse event, photo toxicity and wound healing time) and investigators preference.
|- Main changes (audit trail)|
|- RECORD||2-apr-2013 - 11-apr-2013|