Basal cell carcinoma basalioma
Conditions
Interventions
In the present study two different illuminations schemes will be compared:
- MAL-PDT using two light fractions with one hour interval: illumination at 3
(20 J/cm2) and 4 hours (55 J/cm2) after appli
Sponsors
dermatologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy end point includes the individual sBCC lesion total clearance rate at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary endpoints include: - Reduction in treated lesion size from day 1 at 3 months and 12 months in each group - Relapse rate at 12 months of lesions in complete response in each group - Mean VAS score after each MAL-PDT fractionated treatment in each group - Incidence and severity of adverse event throughout the study | — |
Countries
Netherlands
Outcome results
None listed