Malignant neoplasm of the skin Basal cell carcinoma
Conditions
Interventions
This is an open-label, randomized, controlled, two-arm clinical study. A total of 142 participants who meet the eligibility criteria will be randomly allocated to two intervention groups (control and
irradiance: 125 mW/cm²) for 20 minutes. The second session will involve a new topical application of MAL cream, with an incubation time of 1.5 hours. After this period, the cream will be removed, and
irradiance: 125 mW/cm²) for 20 minutes, followed by irradiation with therapeutic ultrasound (1 MHz, 1.5 W/cm², pulsed mode at 50%) for 5 minutes. The second session will involve a new topical applicat
Sponsors
Instituto de Física de São Carlos, Universidade de São Paulo
Hospital Amaral Carvalho
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients of both sexes; over 18 years of age; patients with malignant Nodular Basal Cell Carcinoma lesions with a maximum diameter of 1 (one) centimeter. Patients with multiple lesions may also be treated, as long as each lesion meets the characteristics described in the previously.
Exclusion criteria
Exclusion criteria: Patients with allergy to any of the excipients present in the formula; Infiltrative Basal Cell Carcinoma, Micro-infiltrative, Sclerodermiform and plano-cicatricial, Terebrant histological subtype, as well as Squamous Cell or Epidermoid Carcinoma and Melanoma; Patients with porphyria; Nodular Basal Cell Carcinoma lesions larger than 1 cm in diameter; Under 18 years of age; Pregnant and lactating women; Women of childbearing age; Photosensitive diseases, for example, Lupus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether the proposed single-visit Sono-Photodynamic Therapy protocol improves the cure rate of single-visit Photodynamic Therapy in Nodular Basal Cell Carcinoma within 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare recurrence for both protocols through clinical and histopathological evaluation after 6 months of treatment. - Evaluate the aesthetic results and pain score associated with both protocols. - Evaluate patient preference regarding the modality: Photodynamic Therapy or Sono-Photodynamic Therapy. | — |
Countries
BR
Contacts
Public ContactAna Salvio
Hospital Amaral Carvalho
Outcome results
None listed