Superficiel basal cell carcinoma treatment with topical photodynamic therapy with fractionated 5-aminolevulinic acid 20% versus two stage methylaminolevulate

Conditions: Superficial basal cell carcinoma
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-005809-77-NL

Lead Sponsor: Maastricht University Medical Centre

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

Minimal age of 18 years
Histological proven BCC
Primary BCC (no previous treatment)
Being able to understand instructions
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 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 81

Exclusion Criteria

Age under 18 years
No histological proven BCC
Recurrent BCC (previously treated)
Not able to understand instructions
Concomitant disease requiring systematic immunosuppressive treatment
Genetic skin cancer disorders

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim: comparing the effects of tumour clearancem between topical PDT with fractionated 5-ALA 20% and MAL in 2 sessions in the treatment of superficial basal cell carcinoma.<br>;Secondary Objective: Aim: comparing the effects in terms costs and patient preferences between topical PDT with fractionated 5-ALA 20% and MAL in 2 sessions in the treatment of superficial basal cell carcinoma.<br>;Primary end point(s): Treatment failure (residual tumour);Timepoint(s) of evaluation of this end point: Histological proven residue or recurrence at 3 months and 12 months posttreatment, respectively. <br><br>If there is any clinical suspicion of residual tumour, a 3 mm punch biopsy will be taken to confirm the diagnosis by histopathology,

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Costs and patient preferences between both treatments.<br>;Timepoint(s) of evaluation of this end point: Costs of both treatments will be evaluated after all patients received treatment.<br><br>Patient preferences will be evaluated twice with a questionnaire, on the last day of treatment and 1 week posttreatment.