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Label indication 1. INDICATIONS AND USAGE AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED ® or RhodoLED ® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. FDA label
Also known as Photodynamic therapy, RhodoLED-XL®, BF-200 ALA gel, BF-200 ALA, BF-200 ALA 10%
Ameluz · 3 trials · 4 indications
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).
Histological clearance is defined as the absence of detectable evidence of SCCis tumor cell nests by the central pathology reports
Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face.
Cosmetic outcomes in photoaging of the face evaluated by Subject and Investigator Global Aesthetic Improvement Scale (GAIS) at 1 and 2 months post last PDT. Scale: Very Satisfied (better than expected), Satisfied (as expected), Unsatisfied (worse than expected)
| 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) |
| Photodynamic Therapy (using Red light dose) | EXPERIMENTAL | 20 participants will be enrolled to this arm |
| Two PDT treatments | EXPERIMENTAL | Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
| 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®. |
| Aminolevulinic acid hydrochloride 10% topical gel with Red Light | COMBINATION_PRODUCT | Participants will have their facial Cutaneous Squamous Cell Carcinoma in situ (SCCis) prepped then treated with Aminolevulinic acid hydrochloride 10% topical gel (Ameluz ®), followed by red light therapy administered for 13 minutes and 30 seconds to deliver the total desired light dose to the SCCis lesion. |
| Ameluz | DRUG | broad band light (BBL) with the use of Ameluz |
| Sciton HEROic | DEVICE | Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
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...
Ameluz is a topical prescription gel containing aminolevulinic acid hydrochloride 10%, developed by Biofrontera Inc. (ticker BFRI). It is used with red light in photodynamic therapy to treat skin conditions including actinic keratoses, cutaneous squamous cell carcinoma, and superficial basal cell carcinoma. It is a small molecule therapy in the dermatology field.
Ameluz is used in photodynamic therapy for actinic keratoses, cutaneous squamous cell carcinoma, and superficial basal cell carcinoma. It is applied to the skin and activated with red light to treat these dermatologic conditions. Biofrontera Inc. (BFRI) is developing it across these indications.
Ameluz is made by Biofrontera Inc., which trades under the ticker BFRI. The company develops the topical gel for use in photodynamic therapy across dermatologic conditions including actinic keratoses and certain skin cancers.
Ameluz is in clinical development, with trials spanning Phase 1 through Phase 3. It is investigational and has not been stated as FDA approved in the available information. Biofrontera Inc. (BFRI) is evaluating it in studies for actinic keratoses, cutaneous squamous cell carcinoma, and superficial basal cell carcinoma.
Ameluz has been studied in trials including NCT07053852, a completed Phase 1 study of activation with BBL HEROic for actinic keratoses and photodamage; NCT06577311, a recruiting Phase 2 study in facial cutaneous squamous cell carcinoma in situ; and NCT03573401, an active Phase 3 study in superficial basal cell carcinoma.