{"id":"protopic-ointment-0-1","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Skin burning sensation"},{"rate":"10-20%","effect":"Skin itching"},{"rate":"5-10%","effect":"Skin redness"},{"rate":"5-10%","effect":"Skin irritation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This is achieved through the inhibition of calcineurin, a protein phosphatase that dephosphorylates and activates NF-κB. By inhibiting NF-κB, Protopic ointment reduces the expression of pro-inflammatory genes, thereby decreasing inflammation. This mechanism of action is particularly useful in treating skin conditions characterized by inflammation.","oneSentence":"Protopic ointment, 0.1% works by inhibiting the transcription factor nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) to reduce inflammation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:30:38.201Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis"},{"name":"Severe psoriasis"}]},"trialDetails":[{"nctId":"NCT06035614","phase":"NA","title":"Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children","status":"COMPLETED","sponsor":"Clarteis","startDate":"2022-10-01","conditions":"Vitiligo, Pediatric ALL, Dermatologic Disease","enrollment":50},{"nctId":"NCT03614221","phase":"PHASE2","title":"Comparison of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® Ointment 0.1% in Treating Atopic Dermatitis","status":"COMPLETED","sponsor":"Chang Gung Memorial Hospital","startDate":"2019-06-03","conditions":"Atopic Dermatitis","enrollment":22},{"nctId":"NCT03152019","phase":"PHASE2","title":"Efficacy and Safety of a 0.1% Tacrolimus Nasal Ointment as a Treatment for Epistaxis in Hemorrhagic Hereditary Telangiectasia (HHT)","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2017-05-22","conditions":"Hemorrhagic Hereditary Telangiectasia (HHT)","enrollment":50},{"nctId":"NCT02601703","phase":"PHASE3","title":"To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)","status":"COMPLETED","sponsor":"Glenmark Pharmaceuticals Ltd. India","startDate":"2015-08","conditions":"Atopic Dermatitis","enrollment":1110},{"nctId":"NCT00762658","phase":"PHASE1","title":"A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test","status":"COMPLETED","sponsor":"Pfizer","startDate":"2007-11-30","conditions":"Psoriasis","enrollment":12},{"nctId":"NCT02004860","phase":"PHASE3","title":"Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis","status":"COMPLETED","sponsor":"University Hospital, Rouen","startDate":"2014-01","conditions":"Severe Seborrheic Dermatitis","enrollment":120},{"nctId":"NCT00480610","phase":"PHASE3","title":"Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2004-04","conditions":"Dermatitis, Atopic","enrollment":226},{"nctId":"NCT00690105","phase":"PHASE4","title":"Protopic Ointment in Adult Atopic Eczema of the Face","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2004-02","conditions":"Dermatitis, Atopic","enrollment":577},{"nctId":"NCT01320579","phase":"PHASE2","title":"Investigation of the Efficacy of 2.5% and 5% Cis-urocanic Acid in Patients With Moderate or Severe Atopic Dermatitis","status":"COMPLETED","sponsor":"BioCis Pharma Ltd","startDate":"2011-03","conditions":"Atopic Dermatitis","enrollment":159}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":86,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Protopic® ointment, 0.1%","genericName":"Protopic® ointment, 0.1%","companyName":"Glenmark Pharmaceuticals Ltd. India","companyId":"glenmark-pharmaceuticals-ltd-india","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Protopic ointment, 0.1% works by inhibiting the transcription factor nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) to reduce inflammation. Used for Atopic dermatitis, Severe psoriasis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}