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The management of actinic keratosis in transplant recipients.


- candidate number14656
- NTR NumberNTR3930
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-apr-2013
- Secondary IDsNL39975.078.12  CCMO
- Public TitleThe management of actinic keratosis in transplant recipients.
- Scientific TitleThe management of actinic keratosis in transplant recipients.
- ACRONYM5-FU_IMQ_PDT
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPatient preferences, Transplantation, Imiquimod, 5-Fluorouracil, Actinic keratosis, Photodynamic therapy
- Inclusion criteria1. 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 criteria1. 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 receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2013
- planned closingdate1-jan-2015
- Target number of participants60
- InterventionsLeft/right MAL-PDT and left/right respectively topical treatment.
- Primary outcomePatients preference.
- Secondary outcome1. Cosmetic outcome;
2. Tolerability;
3. Efficacy.
- TimepointsAfter 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 siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESProf. Dr. H.A.M. Neumann
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.A.M. Neumann
- Sponsor/Initiator Erasmus Medical Center, Department of Dermatology and Venereology
- Funding
(Source(s) of Monetary or Material Support)
Galderma, France
- PublicationsN/A
- Brief summaryObjective:
To determine patientís preference between MAL-PDT and 5-FU and IMQ next to study treatment efficacy, safety and investigators preference of treatments.

Study design:
A randomized monocentric controlled single-blinded study.

Study population:
Solid organ transplant recipients aged 18 years and older which have > 5 mild to moderate AKs on the dorsa of both hands.

Intervention:
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)
- RECORD2-apr-2013 - 13-jan-2014


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