{"id":"levulan-kerastick","safety":{"commonSideEffects":[{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Edema"},{"rate":null,"effect":"Burning/stinging sensation"},{"rate":null,"effect":"Crusting"},{"rate":null,"effect":"Photosensitivity"}]},"_chembl":null,"_dailymed":{"setId":"e45cc371-9ebc-4904-12bc-65cb4e2817ad","title":"LEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [SUN PHARMACEUTICAL INDUSTRIES, INC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Aminolevulinic acid (ALA) is a naturally occurring precursor to protoporphyrin IX, which accumulates preferentially in dysplastic and neoplastic cells. When the skin is exposed to blue light (417 nm wavelength) after ALA application, protoporphyrin IX is activated to produce singlet oxygen and free radicals that cause selective photodynamic destruction of target lesions. This mechanism allows targeted destruction of actinic keratosis and other skin lesions with minimal damage to surrounding normal tissue.","oneSentence":"Levulan (aminolevulinic acid) is a photosensitizing agent that accumulates in skin lesions and generates reactive oxygen species when activated by blue light, destroying abnormal cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T06:11:21.189Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (non-hyperkeratotic, non-hypertrophic lesions on face and scalp)"},{"name":"Actinic keratosis (hyperkeratotic and hypertrophic lesions on face and scalp) when used with occlusion"}]},"trialDetails":[{"nctId":"NCT07144345","phase":"PHASE3","title":"Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2025-11-19","conditions":"Actinic Keratosis","enrollment":160},{"nctId":"NCT07144852","phase":"PHASE3","title":"Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2025-11-29","conditions":"Actinic Keratosis","enrollment":260},{"nctId":"NCT02728388","phase":"PHASE2","title":"Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II","status":"RECRUITING","sponsor":"Donald Basel","startDate":"2016-08","conditions":"NEUROFIBROMATOSIS 1","enrollment":30},{"nctId":"NCT06159842","phase":"PHASE2","title":"Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)","status":"COMPLETED","sponsor":"The Center for Clinical and Cosmetic Research","startDate":"2023-08-08","conditions":"Facial Cutaneous Squamous Cell Carcinoma in Situ","enrollment":32},{"nctId":"NCT03066843","phase":"NA","title":"Photodynamic Therapy Incubation Times for Actinic Keratosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Northwestern University","startDate":"2017-03-01","conditions":"Actinic Keratoses","enrollment":60},{"nctId":"NCT03110159","phase":"PHASE1, PHASE2","title":"DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients","status":"COMPLETED","sponsor":"Medical Dermatology Specialists","startDate":"2017-08-29","conditions":"Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin","enrollment":8},{"nctId":"NCT02124733","phase":"PHASE3","title":"Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2014-04","conditions":"Actinic Keratosis","enrollment":23},{"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":"NCT03114111","phase":"EARLY_PHASE1","title":"Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis","status":"COMPLETED","sponsor":"University of California, Davis","startDate":"2017-01","conditions":"Seborrheic Dermatitis","enrollment":12},{"nctId":"NCT02157623","phase":"NA","title":"Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome","status":"COMPLETED","sponsor":"Edward Maytin, MD, PhD","startDate":"2016-02-01","conditions":"Basal Cell Nevus Syndrome","enrollment":3},{"nctId":"NCT02594644","phase":"NA","title":"The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy","status":"COMPLETED","sponsor":"University of California, Davis","startDate":"2014-11-06","conditions":"Keratosis, Actinic","enrollment":32},{"nctId":"NCT01812837","phase":"NA","title":"The Use of Microneedles in Photodynamic Therapy","status":"COMPLETED","sponsor":"University of California, Davis","startDate":"2012-07","conditions":"Actinic Keratosis","enrollment":51},{"nctId":"NCT01475955","phase":"PHASE2","title":"Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)","status":"COMPLETED","sponsor":"DUSA Pharmaceuticals, Inc.","startDate":"2011-12","conditions":"Actinic Keratosis","enrollment":235},{"nctId":"NCT01458587","phase":"PHASE2","title":"Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)","status":"COMPLETED","sponsor":"DUSA Pharmaceuticals, Inc.","startDate":"2011-11","conditions":"Keratosis, Actinic","enrollment":70}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":19,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Intervention Group"],"phase":"marketed","status":"active","brandName":"Levulan® Kerastick®","genericName":"Levulan® Kerastick®","companyName":"Medical Dermatology Specialists","companyId":"medical-dermatology-specialists","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Levulan (aminolevulinic acid) is a photosensitizing agent that accumulates in skin lesions and generates reactive oxygen species when activated by blue light, destroying abnormal cells. Used for Actinic keratosis (non-hyperkeratotic, non-hypertrophic lesions on face and scalp), Actinic keratosis (hyperkeratotic and hypertrophic lesions on face and scalp) when used with occlusion.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}