{"id":"methyl-aminolaevulinate-16-cream","safety":{"commonSideEffects":[{"rate":"60-90","effect":"Phototoxic reaction (erythema, edema, crusting)"},{"rate":"50-80","effect":"Burning or stinging sensation during illumination"},{"rate":"10-30","effect":"Post-inflammatory hyperpigmentation"},{"rate":"null","effect":"Photosensitivity"},{"rate":"10-20","effect":"Pustules or erosions"}]},"_chembl":{"chemblId":"CHEMBL2108947","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Methyl aminolaevulinate (MAL) is converted to protoporphyrin IX within cells, particularly in dysplastic and malignant keratinocytes. Upon illumination with red light (630 nm wavelength), protoporphyrin IX generates singlet oxygen and free radicals that cause phototoxic damage to treated tissue. This selective accumulation in abnormal cells combined with light activation allows targeted destruction of actinic keratosis and other skin lesions while minimizing damage to surrounding normal tissue.","oneSentence":"Methyl aminolaevulinate is a photosensitizing prodrug that accumulates in abnormal skin cells and generates reactive oxygen species when activated by red light, destroying target lesions.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:41:29.215Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (non-hyperkeratotic, non-pigmented lesions on face and scalp)"},{"name":"Basal cell carcinoma (superficial and nodular types)"}]},"trialDetails":[{"nctId":"NCT03006185","phase":"PHASE2","title":"Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin","status":"COMPLETED","sponsor":"Bispebjerg Hospital","startDate":"2016-08","conditions":"Actinic Keratosis, Sun Damaged Skin, Solar Keratosis","enrollment":18},{"nctId":"NCT03511326","phase":"PHASE4","title":"PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2017-06-07","conditions":"Actinic Keratoses","enrollment":50},{"nctId":"NCT03320447","phase":"PHASE1","title":"Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease","status":"COMPLETED","sponsor":"Dong-A University","startDate":"2011-10-30","conditions":"Bowen's Disease","enrollment":60},{"nctId":"NCT01538901","phase":"PHASE4","title":"Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients","status":"TERMINATED","sponsor":"Medical University of Vienna","startDate":"2012-09","conditions":"Actinic Keratoses","enrollment":10},{"nctId":"NCT02149342","phase":"PHASE1, PHASE2","title":"Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL","status":"COMPLETED","sponsor":"Joint Authority for Päijät-Häme Social and Health Care","startDate":"2014-05","conditions":"Actinic Keratoses","enrollment":14},{"nctId":"NCT02666534","phase":"PHASE1","title":"Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma","status":"COMPLETED","sponsor":"Dong-A University","startDate":"2012-01","conditions":"Microinvasive Squamous Cell Carcinoma","enrollment":45},{"nctId":"NCT02198469","phase":"PHASE1","title":"Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis","status":"COMPLETED","sponsor":"Dong-A University","startDate":"2012-01","conditions":"Actinic Cheilitis","enrollment":33},{"nctId":"NCT02018679","phase":"PHASE1","title":"Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Basal Cell Carcinoma","status":"COMPLETED","sponsor":"Dong-A University","startDate":"2011-03","conditions":"Nodular Basal Cell Carcinoma","enrollment":34},{"nctId":"NCT01912976","phase":"PHASE1","title":"Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Bowen's Disease","status":"COMPLETED","sponsor":"Dong-A University","startDate":"2011-03","conditions":"Bowen's Disease","enrollment":21},{"nctId":"NCT00840359","phase":"PHASE2","title":"Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis","status":"UNKNOWN","sponsor":"Hadassah Medical Organization","startDate":"2009-09","conditions":"Cutaneous Leishmaniasis","enrollment":44}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":28,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["160mg/g of methyl aminolevulinate"],"phase":"marketed","status":"active","brandName":"Methyl Aminolaevulinate 16% Cream","genericName":"Methyl Aminolaevulinate 16% Cream","companyName":"Galderma R&D","companyId":"galderma-r-d","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Methyl aminolaevulinate is a photosensitizing prodrug that accumulates in abnormal skin cells and generates reactive oxygen species upon light activation, destroying target lesions. Used for Actinic keratosis, Basal cell carcinoma (superficial and nodular), Bowen's disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}