Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BF-200 ALA 1% · 1 trial · 1 indication
Total clearance rate of all AK lesions, defined as the percentage of baseline lesions within the target treatment areas showing complete remission at week 12 post treatment.
| Arm | Type | Description |
|---|---|---|
| BF-200 ALA 0% | PLACEBO_COMPARATOR | Topical application of matched placebo gel without containing 5-ALA. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin. |
| BF-200 ALA 1% | EXPERIMENTAL | Topical application of BF-200 ALA gel containing 0.78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin. |
| BF-200 ALA 3% | EXPERIMENTAL | Topical application of BF-200 ALA gel containing 3.8 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin. |
| BF-200 ALA 10% | EXPERIMENTAL | Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin. |
| Name | Type | Description |
|---|---|---|
| BF-200 ALA 1% | DRUG | topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source . |
| BF-200 ALA 3% | DRUG | topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source . |
| BF-200 ALA 10% | DRUG | topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source . |
Inclusion Criteria: * The subjects were willing and able to sign the informed consent form. * Men and women aged between 18 and 85 years. * Had a general good and stable health condition as confirmed by a physical examination and by medical history. * The subjects accepted to abstain from sunbathin...
BF-200 ALA 1% is used for the treatment of actinic keratosis, a skin condition characterized by rough, scaly patches caused by sun damage. It is a topical photodynamic therapy agent being developed by Biofrontera Inc. for dermatological use.
BF-200 ALA 1% contains 5-aminolevulinic acid, a small molecule that is applied topically and activated by light in photodynamic therapy. It works by accumulating in abnormal skin cells, where light exposure triggers a reaction that destroys the targeted cells.
BF-200 ALA 1% is being developed by Biofrontera Inc., a biopharmaceutical company focused on dermatology. The company's stock is listed under the ticker BFRI.
BF-200 ALA 1% is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials ongoing.
BF-200 ALA 1% has been studied in one completed Phase 2 clinical trial, identified as NCT02799030. This randomized, double-blind, placebo-controlled trial enrolled 105 participants with actinic keratosis and evaluated the efficacy of topical photodynamic therapy with 5-aminolevulinic acid.
BF-200 ALA 1% is a formulation containing 5-aminolevulinic acid as its active ingredient. It is a specific product being developed by Biofrontera Inc. for actinic keratosis, and the trial NCT02799030 refers to it as a topical photodynamic therapy with 5-aminolevulinic acid.