Basal cell carcinoma
Conditions
Interventions
Each group had 189 patients, totalizing 567 patients.
In the control group, the surgical removal of the lesion was performed, considered a minor surgical procedure.
In the groups treated with photodyn
Drug
Device
Procedure/surgery
Sponsors
Hospital Amaral Carvalho
Instituto de Física de São Carlos
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients of both sexes; older than 18 years; present malignant lesions of the basal cell carcinoma nodular subtype (according to the International Classification of Diseases ICD 10, code D04.9) with a maximum diameter of two (2) centimeters (initial lesions); patients with multiple lesions may also be treated, provided that each lesion fits the characteristics described in the previous item; patients with impaired neurological or judgmental capacity may be included as long as the responsible relative for their care signs the consent term.
Exclusion criteria
Exclusion criteria: patients allergic to any of the excipients present in the formula; infiltrative basal cell carcinoma subtype histological micro-infiltrative, sclerodermiform, and flat-cicatricial, terebrante, as well as squamous cell carcinoma or epidermoid carcinoma and melanoma; patients with porphyria; nodular lesions of basal cell carcinoma with more than 2 cm in diameter; patients under 18 years of age; pregnant and lactating women; women of childbearing age; patients with photosensitive diseases, for example, lupus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study aimed to randomly compare the effectiveness of photodynamic therapy using ALA or MAL and surgery. Determination of the sample space by the method described by Blackwelder in 1982, requiring 174 patients for each group. Considering a drop of 10%, 189 patients were determined per group, totaling 567 patients.;The ALA-PDT group had a complete response of 90.48% and the MAL-PDT group had 86.10%, verified from biopsy after 30 days of treatment. In the surgery group, 97.25% of the lesions presented free margins by histopathology. | — |
Secondary
| Measure | Time frame |
|---|---|
| After 82 months, the disease-free rate was (77.6 ± 8.0)% for the ALA group, (82.0 ± 4.1)% for the MAL group and (94.7 ± 5.1 )% for the surgery group, ascertained from clinical evaluation. | — |
Countries
Brazil
Contacts
Public ContactAna Salvio
Hospital Amaral Carvalho
Outcome results
None listed