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Also known as Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
Photodynamic therapy · 1 trial · 1 indication
Each subject had one Main Target Lesion. The composite clinical and histological response rate of the subjects' Main Target Lesions is the percentage of subjects with a clinically and histologically cleared Main Target lesion 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion (Visit 5 or Visit 8).
| Arm | Type | Description |
|---|---|---|
| BF-200 ALA | EXPERIMENTAL | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). Photodynamic therapy (PDT) |
| Vehicle | PLACEBO_COMPARATOR | Topical application of vehicle to BF-200 ALA containing no active ingredient. Photodynamic therapy (PDT) |
| Name | Type | Description |
|---|---|---|
| Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) | COMBINATION_PRODUCT | The Main Target Lesion will be marked by at least 3 ink marks prior to PDT to enable precise excision for histopathological assessment 12 weeks after the first or second PDT cycle dependent on the clearance status of the lesion. All target lesions should be prepared prior to drug application by degreasing, removal of all scabs and crusts, and roughening of the surface, if appropriate. Bleeding should be avoided. The formulations will then be applied to the lesions (maximal combined lesion area incl. margin is 20 cm²) located in 1 to 2 illumination areas. The medication should be applied to the entire lesion(s) plus a 0.5 - 1.0 cm margin surrounding each lesion at a thickness of 1 mm, allowed to dry (for approximately 10 minutes), covered with occlusive dressing, and incubated for approximately 3 h. Thereafter, any remnants of the IMP will be removed carefully and the PDT illumination will be administered using the light emitting diode (LED) red light device BF-RhodoLED®. |
| Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) | COMBINATION_PRODUCT | The Main Target Lesion will be marked by at least 3 ink marks prior to PDT to enable precise excision for histopathological assessment 12 weeks after the first or second PDT cycle dependent on the clearance status of the lesion. All target lesions should be prepared prior to drug application by degreasing, removal of all scabs and crusts, and roughening of the surface, if appropriate. Bleeding should be avoided. The formulations will then be applied to the lesions (maximal combined lesion area incl. margin is 20 cm²) located in 1 to 2 illumination areas. The medication should be applied to the entire lesion(s) plus a 0.5 - 1.0 cm margin surrounding each lesion at a thickness of 1 mm, allowed to dry (for approximately 10 minutes), covered with occlusive dressing, and incubated for approximately 3 h. Thereafter, any remnants of the IMP will be removed carefully and the PDT illumination will be administered using the light emitting diode (LED) red light device BF-RhodoLED®. |
Inclusion Criteria: * Willingness and ability to sign the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and a HIPAA form must be obtained in writing for all subjects prior to starting any study procedures. * Men or...
Photodynamic therapy (PDT) is used for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer. It is being evaluated in a Phase 3 clinical trial for this indication. The therapy involves the use of a photosensitizing agent and light activation to target cancer cells.
Photodynamic therapy (PDT) works through a light-activated process. It uses a photosensitizing agent, such as BF-200 ALA (Ameluz), which is applied to the skin and then activated by a specific light source, BF-RhodoLED, to destroy cancerous cells in superficial basal cell carcinoma.
Photodynamic therapy (PDT) is being developed by Biofrontera Inc., a biopharmaceutical company. The company's stock ticker is BFRI. Biofrontera is conducting clinical trials to evaluate the safety and efficacy of this therapy for the treatment of superficial basal cell carcinoma.
Photodynamic therapy (PDT) is currently in Phase 3 clinical development for the treatment of superficial basal cell carcinoma. It is an investigational therapy and has not yet been approved by regulatory authorities. The Phase 3 trial is active but not recruiting participants.
Photodynamic therapy (PDT) is being studied in a Phase 3 clinical trial with the identifier NCT03573401. This trial is evaluating the safety and efficacy of BF-200 ALA (Ameluz) and BF-RhodoLED in the treatment of superficial basal cell carcinoma. The trial is randomized, double-blind, and placebo-controlled, with an enrollment of 187 participants in the United States.
Yes, Photodynamic therapy (PDT) is also known as ALA-PDT and Ameluz-PDT. These names refer to the same therapeutic approach using a photosensitizing agent, such as Ameluz (BF-200 ALA), combined with light activation for the treatment of superficial basal cell carcinoma.