Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients

NCT01538901 | Terminated Phase 4 DMC

• 1 other identifier: IPDTAKOTR/V06/28.12.11
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Actinic Keratoses

Keywords

actinic keratoses; organ transplant recipients; photodynamic therapy; imiquimod

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks after end of treatment

Secondary Outcomes (3)

• clinical complete response rate of actinic keratoses

  6 and 12 months after end of treatment

• global reduction in the area of specific fluorescence

  1, 6 and 12 months after end of treatment

• global patient's satisfaction

  3, 6 and 12 months after end of treatment

Study Arms (2)

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.

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.

Drug: imiquimod 5% cream

Interventions

photodynamic therapy 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.

Also known as: Metvix 160mg/g cream photodynamic therapy

photodynamic therapy

imiquimod 5% cream 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

Also known as: Aldara 5% cream

imiquimod 5% cream

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Medical University of Vienna, University Clinic of Dermatology

Vienna, 1090, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (6)

• 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.

  PMID: 18067628 BACKGROUND

• 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.

  PMID: 15270891 BACKGROUND

• 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.

  PMID: 12079221 BACKGROUND

• 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.

  PMID: 12190879 BACKGROUND

• 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.

  PMID: 18937654 BACKGROUND

• 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.

  PMID: 19091216 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapy; methyl 5-aminolevulinate; Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doz. Dr.

Study Record Dates

• First Submitted: February 19, 2012
• First Posted: February 24, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

AU (2)