actinic keratoses MedDRA version: 14.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Metvix
Product Name: Metvix
Pharmaceutical Form: Cream
Concentration unit: % percent
Concentration type: equal
INN or Proposed INN: methyl aminolevulinate
CAS Number: 33320-16-0
Other desc
Sponsors
Medizinische Universität Wien, Univ. Klinik f. Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 years or older Patients who had received a kidney, liver, lung or heart transplant more than 3 years prior to inclusion into the study Patients who had been treated at least 6 month prior to study entry with a stable twofold or threefold immunsupressive treatment Patients who had clinically confirmed epithelial dysplasia (actinic keratoses) in at least two anatomically separated contralateral areas on the face and/or scalp with comparable size and extension and minimum distance of 5 cm Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Invasive squamous cell carcinoma or basal cell carcinoma in the treatment area Known allergy to imiquimod and aminolaevulinic acid Patients who have received retinoids, interferons or investigational drugs within 4 weeks of study initiation Patients who are participating in other dermatological study Patients with instable organ function Persistent Hepatitis B or C infections Any evidence of systemic cancer Patients who have received any systemic cancer chemotherapy or radiation therapy Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of topical imiquimod 5% cream versus photodynamic therapy with methyl-aminolaevulinate 16% cream in the treatment of actinic keratoses in organ transplant recipients;Secondary Objective: To compare the tolerability, the patients' satisfaction and the duration of the disease-free interval after treatment with topical imiquimod 5% cream versus photodynamic therapy with methyl-aminolaevulinate 16% cream of actinic keratoses in organ transplant recipients To compare the reduction in the field cancerisation after treatment with topical imiquimod 5% cream versus photodynamic therapy with methyl-aminolaevulinate 16% cream of actinic keratoses in organ transplant recipients;Primary end point(s): Clinical complete remission rate of actinic keratoses in organ transplant recipients 4 weeks after completion of treatment with imiquimod 5% cream and photodynamic therapy with methyl-aminoöaevulinate 16% cream;Timepoint(s) of evaluation of this end point: 4 weeks after completion of treatment with imiquimod 5% cream and photodynamic therapy with methyl-aminolaevulinate 16% cream | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical complete remission rate of actinic keratoses in organ transplant recipients 6 and 12 months after completion of treatment with imiquimod 5% cream and photodynamic therapy with methyl-aminolaevulinate 16% cream Global reduction of the area of specific fluorescence 1, 6 and 12 months after completion of treatment with imiquimod 5% cream and photodynamic therapy with methyl-aminolaevulinate 16% cream Treatment-associated Pain during the treatment and 2 and 4 weeks after completion of treatment Cosmetic response 1, 3, 6 and 12 months after completion of treatment Global patients' satisfaction 1, 3, 6 and 12 months after completion of treatment ;Timepoint(s) of evaluation of this end point: Clinical complete remission rate: 6 and 12 months after completion of treatment Global reduction of the area of specific fluorescence: 1, 6 and 12 months after completion of treatment Treatment-associated Pain: during the tratment, 2 and 4 weeks after completion of treatment Cosmetic response 1, 3, 6 and 12 months after completion of treatment Global patients' satisfaction 1, 3, 6 and 12 months after completion of treatment | — |
Countries
Austria
Contacts
Public ContactUniv. Klinik f. Dermatologie
Medizinische Universität Wien, Univ. Klinik f. Dermatologie
Outcome results
None listed