Prophylactic photodynamic therapy for organ transplant patients.

Conditions: Development of actinic keratoses and skin cancer in kidney transplant patients - a randomised, intra-individual trial with blinded outcome evaluation.
MedDRA version: 16.0Level: PTClassification code 10040808Term: Skin cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.0Level: LLTClassification code 10047829Term: Warts (viral)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2008-006863-35-SE

Lead Sponsor: Bispebjerg Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

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

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.