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Clinical Trials/EUCTR2008-006863-35-SE
EUCTR2008-006863-35-SE
Active, not recruiting
Not Applicable

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

Bispebjerg Hospital0 sites50 target enrollmentStarted: July 9, 2013Last updated:
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DrugsMetvix creme

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
50
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

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.

Investigators

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