Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma

NCT07381972 | Recruiting Phase 3

• 2 other identifiers: 7.810.244U1111-1330-4954
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Nodular Basal Cell Carcinoma of Skin

Keywords

Photodynamic Therapy; Sonodynamic Therapy; Non-melanoma skin cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of the complete response rate after one month of treatment.

  Complete response will be defined as the absence of clinical and/or histopathological signs of the tumor after one month of treatment.

  One month after the treatment was applied to the patient.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Photodynamic therapy (PDT) protocol

ACTIVE COMPARATOR

In this arm, lesions will be treated with the conventional PDT protocol for this type of lesion.

Combination Product: Control Arm (Conventional Therapy)

Sono-Photodynamic Therapy (SonoPDT) protocol

EXPERIMENTAL

In this arm, lesions will be treated with a modified treatment protocol called SonoPDT protocol.

Combination Product: Experimental arm

Interventions

Control Arm (Conventional Therapy) COMBINATION_PRODUCT

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.

Photodynamic therapy (PDT) protocol

Experimental arm COMBINATION_PRODUCT

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.

Sono-Photodynamic Therapy (SonoPDT) protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of both sexes, aged 18 years and older.
• Histologically confirmed nodular basal cell carcinoma with lesion diameter ≤1.0 cm.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-080, Brazil

RECRUITING

Related Publications (2)

• Ayala ETP, Carvalho ISE, Antunes CA, Mahmood A, Requena MB, Alves F, Pires L, Yakovlev V, Bagnato VS, Pratavieira S. Comparative analysis of ALA mediated sonodynamic therapy considering tumor size, light combination and ultrasound delivery in murine cutaneous melanoma. Sci Rep. 2025 Aug 22;15(1):30859. doi: 10.1038/s41598-025-16366-x.

  PMID: 40846765 BACKGROUND

• Salvio AG, Veneziano DB, Moriyama LT, Inada NM, Grecco C, Kurachi C, Bagnato VS. A new photodynamic therapy protocol for nodular basal cell carcinoma treatment: Effectiveness and long-term follow-up. Photodiagnosis Photodyn Ther. 2022 Mar;37:102668. doi: 10.1016/j.pdpdt.2021.102668. Epub 2021 Dec 1.

  PMID: 34863948 BACKGROUND

Central Study Contacts

Ana G Salvio, Doctor

CONTACT

+55 (14) 3602-1374; gasalvio@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 2, 2026
• Study Start: November 24, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)