{"id":"sirolimus-topical-cream","safety":{"commonSideEffects":[{"rate":null,"effect":"Local skin irritation"},{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Application site reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Sirolimus (rapamycin) inhibits the mammalian target of rapamycin (mTOR), a key regulator of cell growth and proliferation. In topical form, it reduces T-cell activation and proliferation while also inhibiting angiogenesis, making it potentially useful for skin cancers and precancerous lesions. The mechanism leverages both immunosuppressive and anti-proliferative effects localized to the treatment site.","oneSentence":"Sirolimus is an mTOR inhibitor that suppresses immune cell proliferation and angiogenesis when applied topically to skin lesions.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:34:53.190Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Melanoma (topical treatment)"},{"name":"Non-melanoma skin cancer (topical treatment)"}]},"trialDetails":[{"nctId":"NCT05342519","phase":"PHASE2","title":"Daily Topical Rapamycin for Vitiligo","status":"ACTIVE_NOT_RECRUITING","sponsor":"Medical University of South Carolina","startDate":"2022-07-28","conditions":"Vitiligo","enrollment":20},{"nctId":"NCT03972592","phase":"PHASE2","title":"Topical Sirolimus in Cutaneous Lymphatic Malformations","status":"COMPLETED","sponsor":"University Hospital, Tours","startDate":"2019-06-05","conditions":"Vascular Malformations, Lymphatic Malformation","enrollment":55},{"nctId":"NCT04172922","phase":"PHASE1","title":"Topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and Other Susceptible Lesions","status":"TERMINATED","sponsor":"Nemours Children's Clinic","startDate":"2020-04-01","conditions":"Vascular Anomaly","enrollment":5},{"nctId":"NCT05860881","phase":"PHASE3","title":"Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Melanoma and Skin Cancer Trials Limited","startDate":"2024-02-09","conditions":"Solid Organ Transplant Recipients, Skin Cancer","enrollment":146},{"nctId":"NCT03826628","phase":"PHASE2, PHASE3","title":"Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex","status":"COMPLETED","sponsor":"Dermatology Specialties Limited Partnership","startDate":"2019-07-28","conditions":"Facial Angiofibroma, Tuberous Sclerosis","enrollment":107},{"nctId":"NCT02240407","phase":"PHASE1","title":"Re-administration of Intramuscular AAV9 in Patients With Late-Onset Pompe Disease","status":"COMPLETED","sponsor":"University of Florida","startDate":"2017-10-17","conditions":"Pompe Disease","enrollment":2},{"nctId":"NCT03333694","phase":"PHASE1","title":"Safety, Tolerability, and Efficacy Study of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ (SCCis)","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2017-12-15","conditions":"Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)","enrollment":40},{"nctId":"NCT01526356","phase":"PHASE2","title":"Topical Rapamycin to Erase Angiofibromas in TSC","status":"COMPLETED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2012-05","conditions":"Angiofibromas, Tuberous Sclerosis","enrollment":179},{"nctId":"NCT00079183","phase":"PHASE2","title":"Sirolimus as Secondary Therapy in Chronic Graft-Versus-Host Disease Not Responding To Prior Treatment","status":"COMPLETED","sponsor":"Fred Hutchinson Cancer Center","startDate":"2002-04","conditions":"Graft Versus Host Disease","enrollment":44},{"nctId":"NCT02152007","phase":"PHASE1","title":"Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)","status":"COMPLETED","sponsor":"TransDerm, Inc.","startDate":"2014-01","conditions":"Pachyonychia Congenita","enrollment":15},{"nctId":"NCT01853423","phase":"PHASE1","title":"Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream","status":"COMPLETED","sponsor":"Le Bonheur Children's Hospital","startDate":"2013-10","conditions":"Facial Angiofibroma","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Rapamycin"],"phase":"phase_3","status":"active","brandName":"Sirolimus Topical Cream","genericName":"Sirolimus Topical Cream","companyName":"Melanoma and Skin Cancer Trials Limited","companyId":"melanoma-and-skin-cancer-trials-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sirolimus Topical Cream is being studied for various conditions, including Facial Angiofibroma, Tuberous Sclerosis, Solid Organ Transplant Recipients, Skin Cancer, and Vascular Malformations. It is a topical formulation of the immunosuppressant drug rapamycin, which is also known as Sirolimus.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}