MAL-PDT of superficial basal cell carcinoma using two light fractions with one or two hours interval: comparison of illumination at 3 and 4 hours with illumination at 3 and 5 hours after application of MA
- Conditions
- Basal cell carcinomabasalioma10040900
- Registration Number
- NL-OMON43554
- Lead Sponsor
- dermatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
- Age 18 years or above;- Male and female;- Primary sBCC with size between 1-2 cm;- Willingly to sign a written informed consent
Exclusion Criteria
- Known allergy to MAL or related compounds, or excipients of the cream ;- Participation in other clinical studies in the last 30 days;- Other treatments for skin cancer in the area to be treated in the last 12 weeks;- Likelihood of noncompliance ;- Chronic immunosuppression;- Pregnant or breast-feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy end point includes the individual sBCC lesion total clearance<br /><br>rate at 3 months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary endpoints include:<br /><br>- Reduction in treated lesion size from day 1 at 3 months and 12 months in<br /><br>each group<br /><br>- Relapse rate at 12 months of lesions in complete response in each group<br /><br>- Mean VAS score after each MAL-PDT fractionated treatment in each group<br /><br>- Incidence and severity of adverse event throughout the study</p><br>