Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients
18 Years
80 Years
Both
Actinic Keratoses
Trial Information
Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients
Organ transplant patients (OTP) require lifelong immunosuppressive therapy and consequently
are prone to develop skin tumors, i.e skin cancer is the most frequent malignancy in organ
transplant recipients. OTP frequently develop extensive areas of actinic damage, epidermal
dysplasia, wich accounts for increased risk of aggressive skin cancer development in
susceptible patients, and are referred to as "field cancerisation". Therefore the whole area
of field cancerisation has to be treated. In our study we will treat this areas with two
different methods and not only the single visible lesions of actinic keratoses.In this open
prospective randomized intraindividual study one half of the patients' scalp or face will be
treated with Imiquimod 5% cream for 4 weeks, 3 times a week, and the other half with
Methyl-aminolaevulinate 16% cream photodynamic therapy, two applications in two weeks
interval. The pre- and post treatment extension of field cancerisation will be assessed by
means of a highly sensitive digital fluorescence imaging system.
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 months prior to study entry with a stable
twofold or threefold immunosuppressive 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
Exclusion Criteria:
- Invasive squamous cell carcinoma or basal cell carcinoma in the treatment area
- Known allergy to imiquimod and/or methyl-aminolaevulinate and/or one of the other
components of the investigational products and/or peanut oil
- Patients who have received retinoids, interferons or investigational drugs within 4
weeks of study initiation
- Patients who are participating in othe dermatological study
- Persistent Hepatitis B or C infections
- Any evidence of systemic cancer
- Patients who have received any systemic cancer chemotherapy or radiation therapy
- Pregnant or lactating women
- Patients
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical complete response rate of actinic keratoses
Outcome Description:
The clinical complete response rate of actinic keratoses is defined as a proportion of the number of actinic keratoses with a clinically determined complete clearance(no visible and/or palpable actinic keratoses) to the number of the actinic keratoses at baseline.
Outcome Time Frame:
4 weeks after end of treatment
Safety Issue:
No
Principal Investigator
Stanislava Tzaneva, Doz. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of Vienna, University Clinic of Dermatology, Division of General Dermatology
Authority:
Austria: Austrian Agency for Health and Food Safety (AGES)
Study ID:
IPDTAKOTR/V06/28.12.11
NCT ID:
NCT01538901
Start Date:
September 2012
Completion Date:
September 2014
Related Keywords:
- Actinic Keratoses
- actinic keratoses
- organ transplant recipients
- photodynamic therapy
- imiquimod
- Keratosis
- Keratosis, Actinic
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