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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 keratoses

global 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

Page last updated: August 23, 2015

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