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

Primary Purpose

Actinic Keratoses

Status
Terminated
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
photodynamic therapy
imiquimod 5% cream
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring actinic keratoses, organ transplant recipients, photodynamic therapy, imiquimod

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

photodynamic therapy

imiquimod 5% cream

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical complete response rate of actinic keratoses
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
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
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
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.

Full Information

First Posted
February 19, 2012
Last Updated
September 11, 2017
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01538901
Brief Title
Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
Acronym
AKtransplant
Official Title
Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
prolonged recruitment phase
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
Keywords
actinic keratoses, organ transplant recipients, photodynamic therapy, imiquimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
photodynamic therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
imiquimod 5% cream
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
photodynamic therapy
Other Intervention Name(s)
Metvix 160mg/g cream photodynamic therapy
Intervention Description
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
Drug
Intervention Name(s)
imiquimod 5% cream
Other Intervention Name(s)
Aldara 5% cream
Intervention Description
250 mg imiquimod 5% cream will be applied over night for a total of 3 nights in the week, for duration of 4 weeks
Primary Outcome Measure Information:
Title
Clinical complete response rate of actinic keratoses
Description
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.
Time Frame
4 weeks after end of treatment
Secondary Outcome Measure Information:
Title
clinical complete response rate of actinic keratoses
Description
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.
Time Frame
6 and 12 months after end of treatment
Title
global reduction in the area of specific fluorescence
Description
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.
Time Frame
1, 6 and 12 months after end of treatment
Title
global patient's satisfaction
Description
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.
Time Frame
3, 6 and 12 months after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislava Tzaneva, Doz. Dr.
Organizational Affiliation
Medical University of Vienna, University Clinic of Dermatology, Division of General Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandra Geusau, Prof. Dr.
Organizational Affiliation
Medical University of Vienna, Division of Immunology, Allergy and Infectious Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, University Clinic of Dermatology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
18067628
Citation
Ulrich C, Bichel J, Euvrard S, Guidi B, Proby CM, van de Kerkhof PC, Amerio P, Ronnevig 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(Suppl 2):25-31. doi: 10.1111/j.1365-2133.2007.08269.x.
Results Reference
background
PubMed Identifier
15270891
Citation
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. doi: 10.1111/j.1365-2133.2004.06054.x.
Results Reference
background
PubMed Identifier
12079221
Citation
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. doi: 10.1007/978-3-642-59410-6_30.
Results Reference
background
PubMed Identifier
12190879
Citation
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. doi: 10.1046/j.1523-1747.2002.01814.x.
Results Reference
background
PubMed Identifier
18937654
Citation
Geusau A, Dunkler D, Messeritsch E, Sandor N, Heidler G, Rodler 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.
Results Reference
background
PubMed Identifier
19091216
Citation
Fernandez-Guarino M, Harto A, Sanchez-Ronco M, Perez-Garcia B, Marquet A, Jaen 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.
Results Reference
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Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients

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