Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients (AKtransplant)

September 11, 2017 updated by: Stanislava Tzaneva, Medical University of Vienna

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
      • Vienna, Austria, 1090
        • Medical University of Vienna, University Clinic of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: 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.
Other Names:
  • Metvix 160mg/g cream photodynamic therapy
ACTIVE_COMPARATOR: 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.
Drug: 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
Other Names:
  • Aldara 5% cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical complete response rate of actinic keratoses
Time Frame: 4 weeks after end of treatment
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.
4 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical complete response rate of actinic keratoses
Time Frame: 6 and 12 months after end of treatment
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.
6 and 12 months after end of treatment
global reduction in the area of specific fluorescence
Time Frame: 1, 6 and 12 months after end of treatment
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.
1, 6 and 12 months after end of treatment
global patient's satisfaction
Time Frame: 3, 6 and 12 months after end of treatment
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.
3, 6 and 12 months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Stanislava Tzaneva, Doz. Dr., Medical University of Vienna, University Clinic of Dermatology, Division of General Dermatology
  • Principal Investigator: Alexandra Geusau, Prof. Dr., Medical University of Vienna, Division of Immunology, Allergy and Infectious Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 19, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (ESTIMATE)

February 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPDTAKOTR/V06/28.12.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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