Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Actinic Keratoses
Intervention: photodynamic therapy (Other); imiquimod 5% cream (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s): Stanislava Tzaneva, Doz. Dr., Principal Investigator, Affiliation: Medical University of Vienna, University Clinic of Dermatology, Division of General Dermatology Alexandra Geusau, Prof. Dr., Principal Investigator, Affiliation: Medical University of Vienna, Division of Immunology, Allergy and Infectious Diseases
Overall contact: Stanislava Tzaneva, Doz. Dr., Phone: 0043140400, Ext: 7700, Email: stanislava.tzaneva@meduniwien.ac.at
Summary
The purpose of this study is to compare two different therapies for actinic keratoses in
organ transplant recipients with regard to efficacy and tolerability. The investiagtors are
planning to examine treatment with Imiquimod 5% cream versus treatment with
Methyl-aminolaevulinate 16% cream and subsequent irradiation with red light, so-called
photodynamic therapy, in this patients' group. A secondary objective of our study is to
investigate the reduction in the field cancerisation after both treatments using
fluorescence diagnostic method and digital imaging.
Clinical Details
Official title: Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical complete response rate of actinic keratoses
Secondary outcome: clinical complete response rate of actinic keratosesglobal reduction in the area of specific fluorescence global patient's satisfaction
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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 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
Locations and Contacts
Stanislava Tzaneva, Doz. Dr., Phone: 0043140400, Ext: 7700, Email: stanislava.tzaneva@meduniwien.ac.at
Medical University of Vienna, Vienna 1090, Austria; Recruiting Stanislava Tzaneva, MD, Phone: +431404007702, Email: stanislava.tzaneva@meduniwien.ac.at Alexandra Geusau, MD, Phone: +431404007703, Email: alexandra.geusau@meduniwien.ac.at Stanislava Tzaneva, MD, Principal Investigator
Medical University of Vienna, University Clinic of Dermatology, Vienna 1090, Austria; Not yet recruiting Stanislava Tzaneva, Doz. Dr., Phone: +43140400, Ext: 7700, Email: stanislava.tzaneva@meduniwien.ac.at Alexandra Geusau, Prof. Dr., Phone: +43140400, Ext: 7705, Email: alexandra.geusau@meduniwien.ac.at Alexandra Geusau, Prof. Dr., Principal Investigator Stanislava Tzaneva, Doz. Dr., Principal Investigator
Additional Information
Related publications: Ulrich C, Bichel J, Euvrard S, Guidi B, Proby CM, van de Kerkhof PC, Amerio P, Rønnevig J, Slade HB, Stockfleth E. Topical immunomodulation under systemic immunosuppression: results of a multicentre, randomized, placebo-controlled safety and efficacy study of imiquimod 5% cream for the treatment of actinic keratoses in kidney, heart, and liver transplant patients. Br J Dermatol. 2007 Dec;157 Suppl 2:25-31. Dragieva G, Prinz BM, Hafner J, Dummer R, Burg G, Binswanger U, Kempf W. A randomized controlled clinical trial of topical photodynamic therapy with methyl aminolaevulinate in the treatment of actinic keratoses in transplant recipients. Br J Dermatol. 2004 Jul;151(1):196-200. Stockfleth E, Ulrich C, Meyer T, Christophers E. Epithelial malignancies in organ transplant patients: clinical presentation and new methods of treatment. Recent Results Cancer Res. 2002;160:251-8. Stern RS, Bolshakov S, Nataraj AJ, Ananthaswamy HN. p53 mutation in nonmelanoma skin cancers occurring in psoralen ultraviolet a-treated patients: evidence for heterogeneity and field cancerization. J Invest Dermatol. 2002 Aug;119(2):522-6. Geusau A, Dunkler D, Messeritsch E, Sandor N, Heidler G, Rödler S, Ankersmit J, Zuckermann A, Tschachler E. Non-melanoma skin cancer and its risk factors in an Austrian population of heart transplant recipients receiving induction therapy. Int J Dermatol. 2008 Sep;47(9):918-25. doi: 10.1111/j.1365-4632.2008.03711.x. Fernández-Guarino M, Harto A, Sánchez-Ronco M, Pérez-García B, Marquet A, Jaén P. [Retrospective, descriptive, observational study of treatment of multiple actinic keratoses with topical methyl aminolevulinate and red light: results in clinical practice and correlation with fluorescence imaging]. Actas Dermosifiliogr. 2008 Dec;99(10):779-87. Spanish.
Starting date: September 2012
Last updated: September 6, 2012
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