Clinical trial NCT01538901: Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
Official title: Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Actinic Keratoses
Keywords: actinic keratoses
organ transplant recipients
photodynamic therapy
imiquimod
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Clinical complete response rate of actinic keratoses
timeFrame: 4 weeks after end of treatment
Secondary outcomes:
measure: clinical complete response rate of actinic keratoses
timeFrame: 6 and 12 months after end of treatment
measure: global reduction in the area of specific fluorescence
timeFrame: 1, 6 and 12 months after end of treatment
measure: global patient's satisfaction
timeFrame: 3, 6 and 12 months after end of treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, University Clinic of Dermatology
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, University Clinic of Dermatology, Division of General Dermatology
name: Stanislava Tzaneva, Doz. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna, Division of Immunology, Allergy and Infectious Diseases
name: Alexandra Geusau, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ulrich C, Bichel J, Euvrard S, Guidi B, Proby CM, van de Kerkhof PC, Amerio P, Ronnevig 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(Suppl 2):25-31. doi: 10.1111/j.1365-2133.2007.08269.x.
citation: 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. doi: 10.1111/j.1365-2133.2004.06054.x.
citation: 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. doi: 10.1007/978-3-642-59410-6_30.
citation: 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. doi: 10.1046/j.1523-1747.2002.01814.x.
citation: Geusau A, Dunkler D, Messeritsch E, Sandor N, Heidler G, Rodler 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.
citation: Fernandez-Guarino M, Harto A, Sanchez-Ronco M, Perez-Garcia B, Marquet A, Jaen 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.