Prophylactic photodynamic therapy for organ transplant patients.

Prophylactic photodynamic therapy for organ transplant patients – a randomised, intra-individual trial with blinded outcome evaluation.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006863-35-SE

Enrollment

Registered

2013-07-09

Start date

2013-10-01

Completion date

Unknown

Last updated

2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development of actinic keratoses and skin cancer in kidney transplant patients - a randomised, intra-individual trial with blinded outcome evaluation. MedDRA version: 16.0 Level: PT Classification code 10040808 Term: Skin cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: LLT Classification code 10047829 Term: Warts (viral) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts an

Interventions

Trade Name: Metvix creme Product Name: Metvix Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have undergone a kidney transplant at least 1 year ago. Patients who have given written informed consent and are considered willing to follow the trial protocol. Patients aged 40 years or older. Patients with fair skin type defined as Fitzpatrick skin type I-III. Fertile women must use a reliable form of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients under 40 and over 70 years of age. Patients who have received PDT treatment in the areas under investigation. Patients with dark skin type defined as Fitzpatrick skin type IV-VI. Patients, have signs of dysplastic skin changes in the areas under investigation, such as warts, AK, NMSC, Bowen's disease, keratoacanthoma or infiltrative tumours. Patients known to have an allergy to any constituents of the MAL cream Pregnant or breast-feeding patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: Number of new skincancer and actinic keratoses in PDT-treated side in relative to untreated side.;Secondary Objective: New warts in PDT-treated side in relative to un-treated control.;Primary end point(s): Number of newly developed AK or skin cancer in the treatment areas;Timepoint(s) of evaluation of this end point: 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 72 months after first PDT	—

Measure

Time frame

Main Objective: Number of new skincancer and actinic keratoses in PDT-treated side in relative to untreated side.;Secondary Objective: New warts in PDT-treated side in relative to un-treated control.;Primary end point(s): Number of newly developed AK or skin cancer in the treatment areas;Timepoint(s) of evaluation of this end point: 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 72 months after first PDT

—

Secondary

Measure	Time frame
Secondary end point(s): Number of newly developed viral warts Adverse effects such as pigmentary changes and scar Degree of photodamage and cosmetic outcome;Timepoint(s) of evaluation of this end point: 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 72 months after first PDT	—

Countries

Norway, Sweden

Contacts

Public ContactMerete Haedersdal

Bispebjerg Hospital

mhaedersdal@dadlnet.dk+453531 60 02

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026