{"id":"ameluz-10-topical-gel","safety":{"commonSideEffects":[{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Edema"},{"rate":null,"effect":"Burning/pain at application site"},{"rate":null,"effect":"Crusting"},{"rate":null,"effect":"Photosensitivity"}]},"_chembl":{"chemblId":"CHEMBL2108694","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ameluz contains aminolevulinic acid (ALA), which is converted to protoporphyrin IX in skin cells. When exposed to red light (635 nm wavelength), protoporphyrin IX generates singlet oxygen and reactive oxygen species that selectively damage and destroy target cells. This mechanism is particularly effective against actinic keratosis and other precancerous skin lesions.","oneSentence":"Ameluz is a topical photodynamic therapy agent that generates reactive oxygen species upon light activation to destroy abnormal skin cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:26:59.993Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (field treatment)"},{"name":"Basal cell carcinoma (superficial and nodular)"}]},"trialDetails":[{"nctId":"NCT07201376","phase":"","title":"Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically","status":"RECRUITING","sponsor":"Dartmouth-Hitchcock Medical Center","startDate":"2025-11-14","conditions":"Non-Melanoma Skin Cancer (NMSC), Benign Skin Growth","enrollment":125},{"nctId":"NCT06027619","phase":"PHASE2","title":"Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses","status":"COMPLETED","sponsor":"Case Comprehensive Cancer Center","startDate":"2023-10-02","conditions":"Actinic Keratosis","enrollment":30},{"nctId":"NCT06745999","phase":"PHASE4","title":"Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face","status":"RECRUITING","sponsor":"Psoriasis Treatment Center of Central New Jersey","startDate":"2023-05-03","conditions":"Actinic Keratoses","enrollment":40},{"nctId":"NCT06577311","phase":"PHASE2","title":"Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)","status":"RECRUITING","sponsor":"The Center for Clinical and Cosmetic Research","startDate":"2024-08-14","conditions":"Cutaneous Squamous Cell Carcinoma","enrollment":20},{"nctId":"NCT05359419","phase":"PHASE4","title":"Comparison of Two Modes of Photodynamic Therapy for the Treatment of Actinic Keratosis on the Upper Extremities","status":"UNKNOWN","sponsor":"Goldman, Butterwick, Fitzpatrick and Groff","startDate":"2022-05-15","conditions":"Skin Neoplasms","enrollment":20},{"nctId":"NCT04319159","phase":"PHASE1","title":"Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK)","status":"COMPLETED","sponsor":"Biofrontera Bioscience GmbH","startDate":"2020-03-05","conditions":"Actinic Keratoses","enrollment":48},{"nctId":"NCT02799030","phase":"PHASE2","title":"A Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Biofrontera Bioscience GmbH","startDate":"2006-10","conditions":"Actinic Keratosis","enrollment":105}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ALA gel"],"phase":"marketed","status":"active","brandName":"Ameluz 10% Topical Gel","genericName":"Ameluz 10% Topical Gel","companyName":"Psoriasis Treatment Center of Central New Jersey","companyId":"psoriasis-treatment-center-of-central-new-jersey","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ameluz is a topical photodynamic therapy agent that generates reactive oxygen species upon light activation to destroy abnormal skin cells. Used for Actinic keratosis (field treatment), Basal cell carcinoma (superficial and nodular).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}