Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients (AKtransplant)

NCT01538901 Phase 4 TERMINATED

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.

Details

Lead sponsor	Medical University of Vienna
Phase	Phase 4
Status	TERMINATED
Enrolment	10
Start date	2012-09
Completion	2014-09

Conditions

• Actinic Keratoses

Interventions

• photodynamic therapy
• imiquimod 5% cream

Primary outcomes

• Clinical complete response rate of actinic keratoses — 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.

Countries

Austria