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BF-200 ALA cream
BF-200 ALA cream is a photodynamic therapy agent that uses aminolevulinic acid to generate reactive oxygen species upon light activation, destroying abnormal skin cells.
BF-200 ALA cream is a photodynamic therapy agent that uses aminolevulinic acid to generate reactive oxygen species upon light activation, destroying abnormal skin cells. Used for Actinic keratosis (field treatment), Non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma).
At a glance
| Generic name | BF-200 ALA cream |
|---|---|
| Also known as | 5-aminolaevulenic acid nanoemulsion, Ameluz |
| Sponsor | Joint Authority for Päijät-Häme Social and Health Care |
| Drug class | Photodynamic therapy agent |
| Target | Protoporphyrin IX (photosensitizer generated from aminolevulinic acid) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | FDA-approved |
Mechanism of action
Aminolevulinic acid (ALA) is a prodrug that accumulates in mitochondria of target cells and is converted to protoporphyrin IX, a photosensitizer. Upon illumination with red light, protoporphyrin IX generates singlet oxygen and reactive oxygen species that cause selective destruction of actinic keratosis and other dysplastic skin lesions while sparing normal tissue.
Approved indications
- Actinic keratosis (field treatment)
- Non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma)
Common side effects
- Phototoxic reaction (erythema, edema, crusting)
- Burning or stinging sensation during illumination
- Post-inflammatory hyperpigmentation
- Photosensitivity
Key clinical trials
- Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ® (NA)
- Carbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus (NA)
- Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne Vulgaris: a Prospective Study (NA)
- Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris (NA)
- Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis (NA)
- TMFI Enhances Skin Surface and Epidermal PpIX Fluorescence (PHASE4)
- Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL) (PHASE4)
- Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |