Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Aminolevulinic Acid; Imiquimod; Methyl 5-aminolevulinate

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