No registrations found.
ID
Source
Brief title
Health condition
patients' preference, transplant patients, actinic keratosis, imiquimod, 5-Fluorouracil, Photodynamic therapy.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients preference.
Secondary outcome
1. Cosmetic outcome;
2. Tolerability;
3. Efficacy.
Background summary
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.
Study objective
N/A
Study design
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.
Intervention
Left/right MAL-PDT and left/right respectively topical treatment.
H.A.M. Neumann
Rotterdam
The Netherlands
b.vantienhoven@erasmusmc.nl
H.A.M. Neumann
Rotterdam
The Netherlands
b.vantienhoven@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3772 |
| NTR-old | NTR3930 |
| CCMO | NL39975.078.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |