Nodular Basal Cell Carcinoma of SkinPhase 3NCT07381972
Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
A Phase 3 study testing Experimental arm in people with Nodular Basal Cell Carcinoma of Skin, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodular Basal Cell Carcinoma of Skin
- What is being tested?
- Experimental arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Nov 2025to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-080
Ana G Salvio, Doctor, +55 (14) 3602-1374, gasalvio@hotmail.com
About this study
Official title: Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
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.
Read the 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.
- Conditions
- Nodular Basal Cell Carcinoma of Skin
- Being tested
- Control Arm (Conventional Therapy), Experimental arm
- Keywords
- Photodynamic Therapy, Sonodynamic Therapy, Non-melanoma skin cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Experimental armCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy (PDT) protocol | Active comparator | In this arm, lesions will be treated with the conventional PDT protocol for this type of lesion. Receives: 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. Receives: Combination Product: Experimental arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Six months after the treatment was applied to the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start24 Nov 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nodular Basal Cell Carcinoma of SkinStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Gabriela Salvio, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381972
- Sponsor's protocol ID
- 7.810.244
- Other IDs
- U1111-1330-4954
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40846765Salvio 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.
PubMed 34863948
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07381972
- Acronym / sponsor ID
- 7.810.244
- Conditions
- Nodular Basal Cell Carcinoma of Skin
- Keywords
- Photodynamic Therapy, Sonodynamic Therapy, Non-melanoma skin cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy (PDT) protocol | Active comparator | Combination Product: Control Arm (Conventional Therapy)In this arm, lesions will be treated with the conventional PDT protocol for this type of lesion. |
| Sono-Photodynamic Therapy (SonoPDT) protocol | Experimental | Combination Product: Experimental armIn this arm, lesions will be treated with a modified treatment protocol called SonoPDT protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control 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 product | Photodynamic therapy (PDT) protocol |
| Experimental armSonoPDT 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. | Combination product | Sono-Photodynamic Therapy (SonoPDT) protocol |
Primary outcome
Evaluation of the complete response rate after one month of treatment.
Time frame: 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.
1 secondary outcome
Evaluation of the complete response rate and recurrence-free survival rate after six months of treatment.
Time frame: Six months after the treatment was applied to the patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 40846765Ayala 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.
- Background: PubMed 34863948Salvio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental arm in people with Nodular Basal Cell Carcinoma of Skin, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana G Salvio, Doctor (+55 (14) 3602-1374, gasalvio@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the complete response rate after one month of treatment. (time frame: One month after the treatment was applied to the patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381972, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.