{"id":"bf-200-ala-cream","safety":{"commonSideEffects":[{"rate":null,"effect":"Phototoxic reaction (erythema, edema, crusting)"},{"rate":null,"effect":"Burning or stinging sensation during illumination"},{"rate":null,"effect":"Post-inflammatory hyperpigmentation"},{"rate":null,"effect":"Photosensitivity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"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.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:28:14.863Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (field treatment)"},{"name":"Non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma)"}]},"trialDetails":[{"nctId":"NCT05522036","phase":"NA","title":"Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ®","status":"COMPLETED","sponsor":"Centre Dermatologique du Roy","startDate":"2022-01-01","conditions":"Actinic Keratoses","enrollment":25},{"nctId":"NCT05228483","phase":"NA","title":"Carbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus","status":"UNKNOWN","sponsor":"Xijing Hospital","startDate":"2021-11-23","conditions":"Vulva Lichen Sclerosus","enrollment":134},{"nctId":"NCT04709289","phase":"NA","title":"Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne Vulgaris: a Prospective Study","status":"COMPLETED","sponsor":"Shanghai Dermatology Hospital","startDate":"2020-01-01","conditions":"Acne Vulgaris","enrollment":40},{"nctId":"NCT04167982","phase":"NA","title":"Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris","status":"UNKNOWN","sponsor":"Shanghai Dermatology Hospital","startDate":"2020-03-28","conditions":"Acne","enrollment":234},{"nctId":"NCT04396184","phase":"NA","title":"Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for 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Warts","enrollment":20},{"nctId":"NCT03961607","phase":"NA","title":"Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne","status":"UNKNOWN","sponsor":"Shanghai Dermatology Hospital","startDate":"2019-05-10","conditions":"Acne","enrollment":20},{"nctId":"NCT02367547","phase":"PHASE1, PHASE2","title":"Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL","status":"UNKNOWN","sponsor":"Joint Authority for Päijät-Häme Social and Health Care","startDate":"2015-03","conditions":"Neoplasms, Basal Cell, Carcinoma, Basal Cell, Photochemotherapy","enrollment":117},{"nctId":"NCT03596619","phase":"NA","title":"The Study of Plum-blossom Needling Enhancing Efficacy of Aminolevulinic Acid-photodynamic Therapy for Actinic Keratosis","status":"UNKNOWN","sponsor":"Shanghai Dermatology Hospital","startDate":"2018-08-30","conditions":"Actinic Keratoses","enrollment":250},{"nctId":"NCT03642535","phase":"PHASE4","title":"Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention","status":"UNKNOWN","sponsor":"Shanghai Dermatology Hospital","startDate":"2018-08-30","conditions":"Actinic Keratoses","enrollment":300},{"nctId":"NCT02685592","phase":"PHASE4","title":"Photodynamic Therapy for Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion as a Light Sensitizing Cream","status":"COMPLETED","sponsor":"Joint Authority for Päijät-Häme Social and Health Care","startDate":"2016-02","conditions":"Lentigo Maligna","enrollment":10},{"nctId":"NCT02799069","phase":"PHASE3","title":"Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy","status":"COMPLETED","sponsor":"Biofrontera Bioscience GmbH","startDate":"2008-04","conditions":"Actinic Keratosis","enrollment":571},{"nctId":"NCT01893203","phase":"PHASE4","title":"Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)","status":"COMPLETED","sponsor":"Joint Authority for Päijät-Häme Social and Health Care","startDate":"2013-08","conditions":"Multiple Actinic Keratoses","enrollment":14},{"nctId":"NCT02647151","phase":"PHASE4","title":"Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between MAL Cream and ALA Gel","status":"UNKNOWN","sponsor":"Fundación Instituto Valenciano de Oncología","startDate":"2015-12","conditions":"Actinic Keratosis","enrollment":50},{"nctId":"NCT02520700","phase":"NA","title":"A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses","status":"COMPLETED","sponsor":"St Vincent's University Hospital, Ireland","startDate":"2013-09","conditions":"Actinic Keratoses","enrollment":22},{"nctId":"NCT01481155","phase":"NA","title":"Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses","status":"UNKNOWN","sponsor":"Ruhr University of Bochum","startDate":"2011-03","conditions":"Actinic Keratosis","enrollment":21},{"nctId":"NCT00988455","phase":"PHASE1, PHASE2","title":"Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up","status":"COMPLETED","sponsor":"Shahid Beheshti University of Medical Sciences","startDate":"2008-01","conditions":"Basal Cell Carcinoma","enrollment":28}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["5-aminolaevulenic acid 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The cream contains aminolevulinic acid (ALA), which is a precursor to the photosensitizer protoporphyrin IX, involved in the photodynamic therapy process.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}