{"id":"mal-16-8-cream","safety":{"commonSideEffects":[{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Edema"},{"rate":null,"effect":"Crusting"},{"rate":null,"effect":"Burning sensation"},{"rate":null,"effect":"Photosensitivity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Methyl aminolevulinate (MAL) is a prodrug that penetrates skin tissue and is converted to protoporphyrin IX, a photosensitizer. When exposed to red light during photodynamic therapy (PDT), protoporphyrin IX generates singlet oxygen and reactive oxygen species that cause selective destruction of target cells, particularly abnormal keratinocytes and dysplastic lesions. This mechanism allows targeted treatment of actinic keratosis and other skin lesions with minimal damage to surrounding healthy tissue.","oneSentence":"MAL 16.8% cream is a topical formulation of methyl aminolevulinate that generates reactive oxygen species upon light activation to destroy abnormal skin cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:20:06.302Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (field treatment)"},{"name":"Basal cell carcinoma (superficial and nodular)"}]},"trialDetails":[{"nctId":"NCT03909646","phase":"PHASE4","title":"Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease","status":"COMPLETED","sponsor":"Maastricht University Medical Center","startDate":"2019-05-27","conditions":"Bowen's Disease","enrollment":250},{"nctId":"NCT04269395","phase":"PHASE3","title":"A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study","status":"TERMINATED","sponsor":"Galderma R&D","startDate":"2020-04-07","conditions":"Keratosis, Actinic","enrollment":125},{"nctId":"NCT04085367","phase":"PHASE3","title":"Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2019-09-30","conditions":"Actinic Keratoses","enrollment":557}],"_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":["CD06809-41"],"phase":"phase_3","status":"active","brandName":"MAL 16.8% cream","genericName":"MAL 16.8% cream","companyName":"Galderma R&D","companyId":"galderma-r-d","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MAL 16.8% cream is used to treat Actinic Keratoses, Bowen's Disease, and Keratosis, Actinic, based on clinical trials. The exact mechanism of MAL 16.8% cream is unknown.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}