Comparative study for efficacy and tolerability of topical imiquimod 5% cream therapy versus photodynamic therapy (ALA-PDT) of actinic keratoses on the hands and forearms in organ transplant recipients - Imiquimod versus PDT für AK bei OTP

Medizinische Universität Wien, Univ. Klinik f. Dermatologie0 个研究点目标入组 30 人开始时间: 2012年5月29日最近更新: 2018年2月12日

试验速览

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•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 month prior to study entry with a stable twofold or threefold immunsupressive treatment
•Patients who have clinically confirmed epithelial dysplasia (actinic keratoses), equally distributed in contralateral areas on the hands or forearms
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Invasive squamous cell carcinoma or basal cell carcinoma in the treatment area
•Known allergy to imiquimod and aminolevulinic acid
•Patients who have received retinoids, interferons or investigational drugs within 4 weeks of study initiation
•Patients who are participating in other dermatological study
•Patients with instable organ function
•Persistent Hepatitis B or C infections
•Any evidence of systemic cancer
•Patients who have received any systemic cancer chemotherapy or radiation therapy
•Pregnant and lactating women
•Patients with other dermatological diseases (psoriasis, eczema) who might confound clinical outcome
•Pateitns unable to sticjk with the study protocol
•Severe compromised general state

发起方

Medizinische Universität Wien, Univ. Klinik f. Dermatologie