STUDY TO ASSESS IF THE DAYLIGHT PHOTODYNAMIC THERAPY WITH METHYL AMINOLEVULINATE CREAM (METVIX?), (MAL-PDT) IS USEFUL TO PREVENT PRECANCEROUS CUTANEOUS LESIONS AND NON MELANOMA SKIN CANCER IN TRANSPLANT PATIENTS

Phase 1

• Conditions: Actinic Keratosis (AK) are histologically characterized by the proliferation of keratinocytes with atypical cytology in the epidermis. One of the main risk factors for its occurrence is immunosuppression.; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002663-42-ES
• Lead Sponsor: Clínica Universidad de Navarra/Universidad de Navarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-11
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

All patients should meet all of the following inclusion criteria:
1.Transplanted liver, heart or kidney patients with diagnosis of photo-actinic damage.
2.Legal age patients: greater than or equal to 18 years old.
3.The patient should voluntarily sign the informed consent before performing any test trial which is not part of routine care of patients.
4.The patient should, according to the investigator's opinion, be able to comply with all requirements of the clinical trial.
5.Minimum 5 years of transplant.
6.Presence of at least 5 actinic keratosis in symmetrical areas to be treated in each hemiface and/or hemi-scalp, if appropriate.
7.For women of childbearing age, negative pregnancy test at selection time.
It is considered that a woman has not reproductive capacity if she´s postmenopausal (a minimum of two years without menstruation) or have undergone surgical sterilization (at least one month prior to the study). It is considered acceptable to include women using a safe means of contraception (abstinence is considered an acceptable method) throughout the study period and at least another month.

Pregnant women will be excluded from the study. Women of childbearing age will be performed a pregnancy test. Most transplanted women with actinic damage are in postmenopausal age so it is probably not include any woman of childbearing age.
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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

Patients presenting any of the following exclusion criteria will not be able to be included into the clinical trial:
1.Hypersensitivity to the active substances of the drug or any of its excipients (including allergy to peanuts or soybeans).
2.Patients with porphyria.
3.Pregnant or Breastfeeding women*.
*Treatment with Metvix is not recommended during pregnancy. Breastfeeding should be discontinued during Metvix treatment and for 48 hours after treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified