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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Stanislava Tzaneva, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01538901
First received: February 19, 2012
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Actinic Keratoses
Other: photodynamic therapy
Drug: imiquimod 5% cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Clinical complete response rate of actinic keratoses [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • clinical complete response rate of actinic keratoses [ Time Frame: 6 and 12 months after end of treatment ] [ Designated as safety issue: No ]
    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.

  • global reduction in the area of specific fluorescence [ Time Frame: 1, 6 and 12 months after end of treatment ] [ Designated as safety issue: No ]
    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.

  • global patient's satisfaction [ Time Frame: 3, 6 and 12 months after end of treatment ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 34
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Aldara 5% cream

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538901

Contacts
Contact: Stanislava Tzaneva, Doz. Dr. 0043140400 ext 7700 stanislava.tzaneva@meduniwien.ac.at
Contact: Alexandra Geusau, Prof. Dr. 0043140400 ext 7705 alexandra.geusau@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, University Clinic of Dermatology Not yet recruiting
Vienna, Austria, 1090
Contact: Stanislava Tzaneva, Doz. Dr.    +43140400 ext 7700    stanislava.tzaneva@meduniwien.ac.at   
Contact: Alexandra Geusau, Prof. Dr.    +43140400 ext 7705    alexandra.geusau@meduniwien.ac.at   
Principal Investigator: Alexandra Geusau, Prof. Dr.         
Principal Investigator: Stanislava Tzaneva, Doz. Dr.         
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Stanislava Tzaneva, MD    +431404007702    stanislava.tzaneva@meduniwien.ac.at   
Contact: Alexandra Geusau, MD    +431404007703    alexandra.geusau@meduniwien.ac.at   
Principal Investigator: Stanislava Tzaneva, MD         
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Stanislava Tzaneva, Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01538901     History of Changes
Other Study ID Numbers: IPDTAKOTR/V06/28.12.11
Study First Received: February 19, 2012
Last Updated: September 6, 2012
Health Authority: Austria: Austrian Agency for Health and Food Safety (AGES)

Keywords provided by Medical University of Vienna:
actinic keratoses
organ transplant recipients
photodynamic therapy
imiquimod

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Aminolevulinic Acid
Methyl 5-aminolevulinate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014