non melanoma skin cancer MedDRA version: 16.0 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 5-Aminolevilinic Acid
Product Code: 5-ALA
Pharmaceutical Form: Cream
INN or Proposed INN: 5-Aminolevulinic acid
CAS Number: 106-60-5
Other descriptive name: METHYL AMINOLEVULINATE
Concen
Sponsors
Medizinische Universität Wien, Univ.Klinik.f.Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. 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 cosmetic response and global patients' satisfaction 3, 6, and 12 months after completion of therapy in both treatment groups | — |
Countries
Austria
Contacts
Public ContactUniv. Klinik für Dermatologie
Medizinische Universität Wien, Univ Klinik für Dermatologie
Outcome results
None listed