PDT versus PDT in combination with 5% Imiquimod in patients with non melanoma skin cancer

Conditions: non melanoma skin cancer
MedDRA version: 16.0Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-000092-33-AT

Lead Sponsor: Medizinische Universität Wien, Univ.Klinik.f.Dermatologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with clinically confirmed non melanoma skin cancer elswhere on the body
Age 18 years or older
Are the trial subjects under 18? no
Number of subjects for this age range:
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 88

Exclusion Criteria

known allergy to imiquimod and aminolevulinic acid
patients who are participating in another study
patients with instable organ function
pregnant or lactating women
patients unable to stick to the study protocoll
patients with severe compromised general state
Patients with porphyria or taking photosensitizing drugs

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of photodynamic therapy in combination with 5% Imiquimod versus photodynamic monotherapy in patients with non melanoma skin cancer;Secondary Objective: To compare the tolerability, relapse rate, patients' satisfaction, cosmetic result and the clinical response rates after treatment with photodynamic monotherapy versus photodynamic therapy in combination with 5%Imiquimod;Primary end point(s): Percentage of non-melanoma skin tumors cleared 3 months after completion of treatment in both groups;Timepoint(s) of evaluation of this end point: Clinical control after 3, 6 and 12 months after treatment with PDT or PDT mono or in combination with Imiquimod

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The recurrence rate of non-melanoma skin cancer at 6 and 12 months after completion of therapy in both treatment groups.<br>Cosmetic response and global patients satisfaction.;Timepoint(s) of evaluation of this end point: Recurrence rate 6 and 12 months after completion of therapy in both treatment groups<br>cosmetic response and global patients' satisfaction 3, 6, and 12 months after completion of therapy in both treatment groups<br><br>