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.
Conditions
Interventions
Trade Name: Metvix
Product Name: Metvix (metil-aminolevulinato)
Pharmaceutical Form: Cream
INN or Proposed INN: 5-aminolevulinic acid
CAS Number: 33320-16-0
Current Sponsor code: Metvix
Other descript
Sponsors
Clínica Universidad de Navarra/Universidad de Navarra
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess if there are less appearance of AK in the side treated with repeated treatments of daylight photodynamic therapy compared with the side treated with cryotherapy, in transplant patients, at 21 months from treatment initiation.;Secondary Objective: 1. Assess the differences in the number of new AK and NMSC between the two treatments at 3, 9, 15 and 21 months. 2. Assess the differences in the number of persistent AK and NMSC between the two treatments at 3, 9, 15 and 21 months. 3. Assess the differences in the time to onset of the first AK and NMSC between the two treatments. 4. To establish the safety of the procedure. 5. Assess the differences in cosmetic outcome between treatments at different measurement times. 6. Assess the differences in patient preference between the two treatments at different measurement times. 7. Assess the differences in patient satisfaction between the two treatments at different measurement times. 8. Assess the differences in the quality of life of patients between treatments, before starting the study and at the end study (last visit).;Primary end point(s): 1. Number of QA on the side that is going to be applied cryotherapy 2. Number of QA on the side that is going to be applied PDT-MAL-visible light 3. Number of new QA on the side of cryotherapy 4. Number of new QA on the side of the visible-light MAL-PDT 5. Number of NMSC on the side of cryotherapy 6. Number of NMSC on the side of the visible-light-MAL TFD 7. Number of persistent QA on the side of cryotherapy 8. Number of persistent QA on the side of the visible-light MAL-PDT;Timepoint(s) of evaluation of this end point: 1. Number of AK on the side that is going to be applied PDT-MAL-visible light. V0. 2. Number of AK on the side that is going to be applied cryotherapy. V0. 3. Number of new AK on the side that is to be applied PDT-MAL-visible light. V3, V9, V15 and V21. 4. Number of new AK on the side that is going to be applied cryotherapy. V3, V9, V15 and V21. 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Presence of daylight-PDT-MAL of adverse effects. 2. Presence of cryotherapy adverse effects. 3. Ratings in quality of life scale (Skindex-29) for each of the sides. 4. Patient preference (MAL-PDT in daylight / cryotherapy). 5. Scale score tolerance for each of the two treated areas. 6. Rating on the scale of satisfaction for each of the two areas treated. 7. Cosmetic improvement of the 2 sides from baseline V0.;Timepoint(s) of evaluation of this end point: 1. Presence of daylight-MAL-PDT adverse effects. V0, V0b, V3, V3b, V9, V9b, V15, V21. 2. Presence of cryotherapy adverse effects. V0, V0B, V3, V3b, V9, V9b, V15, V21. 3. Ratings in quality of life scale (Skindex-29) for each side. V0 and V21. 4. Patient preference (MAL-PDT in daylight / cryotherapy). V0b, V3b, V9b, V15 and V21. 5. Rating on scale of tolerance for each of the two areas treated. V0b, V3b, V9b. 6. Rating on the scale of satisfaction for each of the two areas treated V3, V9, V15, V21. 7. Cosmetic improvement of the 2 sides cosmetics from baseline V0. V3, V9, V15, V21. V0b: Visit at 15 days from V0; V3b: Visit at 15 days from V3; V9b: Visit at 15 days from V9. | — |
Countries
Spain
Contacts
Public ContactUCEC
Clínica Universidad de Navarra
Outcome results
None listed