Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Actinic Keratoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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photodynamic therapy

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.

Group Type EXPERIMENTAL

photodynamic therapy

Intervention Type OTHER

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.

imiquimod 5% cream

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.

Group Type ACTIVE_COMPARATOR

imiquimod 5% cream

Intervention Type DRUG

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

Interventions

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photodynamic therapy

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.

Intervention Type OTHER

imiquimod 5% cream

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

Intervention Type DRUG

Other Intervention Names

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Metvix 160mg/g cream photodynamic therapy Aldara 5% cream

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No