Actinic KeratosesPhase 4AKtransplantNCT01538901
Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
A Phase 4 study testing photodynamic therapy and imiquimod 5% cream in people with Actinic Keratoses, run by Medical University of Vienna at 2 sites in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- photodynamic therapy and imiquimod 5% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustria
- Study dates
- Sep 2012to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients who have received any systemic cancer chemotherapy or radiation therapy
- Pregnant or lactating women
- Patients
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University of Vienna, University Clinic of Dermatology
Vienna, 1090
Medical University of Vienna
Vienna, 1090
About this study
Official title: 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.
Read the 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.
- Conditions
- Actinic Keratoses
- Being tested
- photodynamic therapy, imiquimod 5% cream
- Keywords
- actinic keratoses, organ transplant recipients, photodynamic therapy, imiquimod
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photodynamic therapyOther
Also called Metvix 160mg/g cream 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.
imiquimod 5% creamDrug
Also called Aldara 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
| Study group | Role | What they receive |
|---|---|---|
| photodynamic therapy | Experimental | 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. Receives: Other: photodynamic therapy |
| imiquimod 5% cream | Active comparator | 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. Receives: Drug: imiquimod 5% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after end of treatment
Secondary outcomes (3)
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.
Measured: 6 and 12 months after end of treatment
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.
Measured: 1, 6 and 12 months after end of treatment
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.
Measured: 3, 6 and 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: prolonged recruitment phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislava Tzaneva, Medical University of Vienna
- Investigators
- Stanislava Tzaneva, Doz. Dr., Principal investigator, Medical University of Vienna, University Clinic of Dermatology, Division of General DermatologyAlexandra Geusau, Prof. Dr., Principal investigator, Medical University of Vienna, Division of Immunology, Allergy and Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538901
- Sponsor's protocol ID
- IPDTAKOTR/V06/28.12.11
- Acronym
- AKtransplant
- Status last verified
- Sep 2017
- First submitted
- 19 Feb 2012
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18067628Dragieva 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.
PubMed 15270891Stockfleth 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.
PubMed 12079221Stern 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.
PubMed 12190879Geusau 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.
PubMed 18937654Fernandez-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.
PubMed 19091216
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT01538901
- Acronym / sponsor ID
- AKtransplant / IPDTAKOTR/V06/28.12.11
- Conditions
- Actinic Keratoses
- Keywords
- actinic keratoses, organ transplant recipients, photodynamic therapy, imiquimod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: prolonged recruitment phase
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| photodynamic therapy | Experimental | Other: photodynamic therapyMethyl-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. |
| imiquimod 5% cream | Active comparator | Drug: imiquimod 5% cream250 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photodynamic therapyAlso: Metvix 160mg/g cream photodynamic therapyMethyl-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 | photodynamic therapy |
| imiquimod 5% creamAlso: Aldara 5% cream250 mg imiquimod 5% cream will be applied over night for a total of 3 nights in the week, for duration of 4 weeks | Drug | imiquimod 5% cream |
Primary outcome
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.
3 secondary outcomes
clinical complete response rate of actinic keratoses
Time frame: 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
global patient's satisfaction
Time frame: 3, 6 and 12 months after end of treatment
Results and safety
The study was stopped early (reason given: prolonged recruitment phase). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Background: PubMed 18067628Ulrich 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.
- Background: PubMed 15270891Dragieva 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.
- Background: PubMed 12079221Stockfleth 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.
- Background: PubMed 12190879Stern 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.
- Background: PubMed 18937654Geusau 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.
- Background: PubMed 19091216Fernandez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislava Tzaneva, Doz. Dr. principal investigator
Medical University of Vienna, University Clinic of Dermatology, Division of General Dermatology
Alexandra Geusau, Prof. Dr. principal investigator
Medical University of Vienna, Division of Immunology, Allergy and Infectious Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing photodynamic therapy and imiquimod 5% cream in people with Actinic Keratoses, run by Medical University of Vienna at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: prolonged recruitment phase). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical complete response rate of actinic keratoses (time frame: 4 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538901, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.