Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

Keratosis, Actinic

Keratosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Precancerous Conditions

Neoplasms, Squamous Cell

Dermatologic Agents

All Drugs and Chemicals

Afamelanotide

Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months

Placebo implant administered subcutaneously every 60 days for 24 months

16 mg subcutaneous implant administered every 60 days

Afamelanotide (CUV1647)

Placebo subcutaneous implant administered every 60 days

Placebo

Günther Hofbauer, M.D.

The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.

The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.

Phase II AK Study in Organ Transplant Patients

A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.

Clinuvel Pharmaceuticals Limited

Dr Dennis Wright

Pharmaceutical Solutions

Antineoplastic Agents

Anti-Infective Agents

Aminolevulinic Acid

Imiquimod

Methyl 5-aminolevulinate

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Methyl-aminolaevulinate 16% cream (Metvix 160mg/g cream) will be applied 1 mm thick on the treated area, which has a maximal diameter of 8 cm2, and will be covered with a semipermeable dressing (Suprasorb F, Lohmann \& Rauscher, Vienna, Austria)for 3 hours. Afterwards the cream leftovers will be removed by 0.9% NaCl solution. Following the treated area will be irradiated with heat-free visible red light at a peak wavelength of 630 nm with a single dose of 37 J/cm2 (Actilite model: CL128, PhotoCure, Norway). This treatment will be repeated in two weeks.

250 mg imiquimod 5% cream (Aldara 5% cream) will be applied over night, for a total of 3 nights in a week, for duration of 4 weeks.

Methyl-aminolaevulinate 16% cream (Metvix) will be applied on the treated area under occlusion for 3 hours. It follows irradiation with visible red light at a peak wavelength of 630 nm (Actilite CL128) with a single dose of 37 J/cm2.

photodynamic therapy

250 mg imiquimod 5% cream will be applied over night for a total of 3 nights in the week, for duration of 4 weeks

imiquimod 5% cream

Stanislava Tzaneva, Doz. Dr.

Alexandra Geusau, Prof. Dr.

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.

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.

Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients

Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients

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.

Prior to photodynamic therapy an illumination of the treated area with a Wood light will be prepared (fluorescence diagnostik). The specific fluorescence will be detected and documented using the non-invasive fluorescence-imaging system Dyaderm, Biocam, Germany.

The global patient's satisfaction will be determined by the patients themselves on a 10 cm visual analog scale. 0 means extremely unsatisfied, 1-3 means unsatisfied, 5-7 means moderately satisfied, 8-10 means highly satisfied.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II AK Study in Organ Transplant Patients	NCT00829192	Actinic Keratos... Carcinoma, Squa... Organ Transplan...	Afamelanotide (... Placebo	18 Years - 75 Years	Clinuvel Pharmaceuticals Limited
Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients	NCT01538901	Actinic Keratos...	photodynamic th... imiquimod 5% cr...	18 Years - 80 Years	Medical University of Vienna
Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients	NCT01538901	Actinic Keratos...	photodynamic th... imiquimod 5% cr...	18 Years - 80 Years	Medical University of Vienna
Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients	NCT01538901	Actinic Keratos...	photodynamic th... imiquimod 5% cr...	18 Years - 80 Years	Medical University of Vienna

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