Recruiting PHASE3 Nodular Basal Cell Carcinoma of Skin

New treatment option for Nodular Basal Cell Carcinoma of Skin

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

ClinicalTrials.gov ID: NCT07381972

What this study is testing

What is Control Arm (Conventional Therapy)?

Control Arm (Conventional Therapy) is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for nodular basal cell carcinoma of skin.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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 .

You likely can't join 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...
  • Porphyria or other disorders of porphyrin metabolism.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential not using an acceptable method of contraception.
See the full eligibility criteria
Who can 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 .
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Jaú, São Paulo, Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Jaú, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.