N/A
ID
Bron
Verkorte titel
Aandoening
patients' preference, transplant patients, actinic keratosis, imiquimod, 5-Fluorouracil, Photodynamic therapy.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Patients preference.
Achtergrond van het onderzoek
Objective:
To determine patient’s 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 patient’s 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.
Doel van het onderzoek
N/A
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
Left/right MAL-PDT and left/right respectively topical treatment.
Publiek
H.A.M. Neumann
Rotterdam
The Netherlands
b.vantienhoven@erasmusmc.nl
Wetenschappelijk
H.A.M. Neumann
Rotterdam
The Netherlands
b.vantienhoven@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3772 |
| NTR-old | NTR3930 |
| CCMO | NL39975.078.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |