Nodular Basal Cell Carcinoma of Skin
Conditions
Keywords
Photodynamic Therapy, Sonodynamic Therapy, Non-melanoma skin cancer
Brief summary
Evaluation of a therapeutic protocol based on the combination of photodynamic therapy and sonodynamic therapy, referred to as sonophotodynamic therapy. Since this new protocol is applied in a single day, it is called the single-visit Sono-PDT protocol. This protocol will be used for the treatment of nodular basal cell carcinoma lesions.
Detailed description
In the proposed treatment protocol, all the procedures of traditional PDT protocol will be maintained, with the addition of a dose of low-intensity therapeutic ultrasound immediately after the application of red light. Ultrasound, due to its greater ability to penetrate the skin, can help reach deeper tumor cells and thus improve treatment outcomes.
Interventions
COMBINATION_PRODUCTControl Arm (Conventional Therapy)
PDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Following the illumination procedure, the second session begins with a new application of MAL cream and an additional 1.5 hours of incubation. After this period, illumination is performed using the same light parameters as in the first session. After each MAL application, an occlusive dressing composed of PVC film, aluminum foil, gauze, and adhesive tape is applied to the lesion area to prevent light exposure and degradation of the produced PpIX.
COMBINATION_PRODUCTExperimental arm
SonoPDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Immediately after illumination, the lesion will be irradiated with ultrasound (frequency: 1MHz, mode: pulsed, ultrasound intensity: 1.5 W/cm2, duty cycle: 50%, pulse frequency: 100 Hz) for 5 minutes. Following the sonication procedure, the second session begins with a new application of MAL cream with an incubation period of 1.5 hours. After this time, illumination and sonication are performed using the same excitation source parameters as in the first session.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults of both sexes, aged 18 years and older. * Histologically confirmed nodular basal cell carcinoma with lesion diameter ≤1.0 cm. * Participants with multiple lesions may be included, provided that each lesion meets all inclusion criteria.
Exclusion criteria
* Nodular basal cell carcinoma lesions \>1.0 cm in diameter. * Known hypersensitivity or allergy to methyl aminolevulinate (MAL) or any excipients of the study medication. * Histological subtypes of infiltrative basal cell carcinoma, including micronodular, infiltrative, sclerodermiform (morpheaform), plano-cicatricial, or terebrant subtypes. * Porphyria or other disorders of porphyrin metabolism. * Pregnant or breastfeeding women. * Women of childbearing potential not using an acceptable method of contraception. * Presence of photosensitive diseases, including lupus erythematosus. * Any condition that, in the investigator's opinion, would interfere with study participation or safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the complete response rate after one month of treatment. | One month after the treatment was applied to the patient. | Complete response will be defined as the absence of clinical and/or histopathological signs of the tumor after one month of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the complete response rate and recurrence-free survival rate after six months of treatment. | Six months after the treatment was applied to the patient. | Complete response will be defined as the absence of clinical and/or histopathological evidence of the tumor. Recurrence-free survival at 6 months will be determined by the proportion of patients who show no recurrence of the lesion at the treated site or in adjacent areas within 6 months, relative to the total number of patients treated. |
Countries
Brazil
Contacts
CONTACTAna G Salvio, Doctor
Outcome results
None listed