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When applied topically as an ointment, it provides localized immunosuppression without the systemic effects associated with oral calcineurin inhibitors.","oneSentence":"Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation and cytokine production to reduce skin inflammation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:10:51.654Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis (eczema)"},{"name":"Vitiligo"}]},"trialDetails":[{"nctId":"NCT07367932","phase":"PHASE4","title":"Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis","status":"NOT_YET_RECRUITING","sponsor":"Cairo University","startDate":"2026-02","conditions":"Dermatitis, Atopic, Eczema","enrollment":30},{"nctId":"NCT05856994","phase":"PHASE1","title":"Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns","status":"RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2024-09-19","conditions":"Burn Injury","enrollment":18},{"nctId":"NCT05607901","phase":"PHASE2","title":"A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone","status":"COMPLETED","sponsor":"Tanta University","startDate":"2022-10-28","conditions":"Dermatologic Disease","enrollment":100},{"nctId":"NCT06203470","phase":"PHASE4","title":"Botox Versus Tacrolimus in Psoriasis Vulgaris","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2024-06","conditions":"Psoriasis Vulgaris","enrollment":60},{"nctId":"NCT04056962","phase":"PHASE2","title":"Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma","status":"RECRUITING","sponsor":"West China Hospital","startDate":"2019-09-01","conditions":"Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma","enrollment":50},{"nctId":"NCT06348602","phase":"PHASE1, PHASE2","title":"Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT","status":"RECRUITING","sponsor":"Hospital Universitario Dr. Jose E. 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SEI","status":"COMPLETED","sponsor":"Benha University","startDate":"2018-04-01","conditions":"Corneal Disease","enrollment":63},{"nctId":"NCT03535051","phase":"NA","title":"Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo","status":"COMPLETED","sponsor":"Kasr El Aini Hospital","startDate":"2015-01-01","conditions":"Stable Vitiligo","enrollment":27},{"nctId":"NCT03199664","phase":"PHASE4","title":"Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo","status":"UNKNOWN","sponsor":"South Valley University","startDate":"2017-09-01","conditions":"Vitiligo","enrollment":100},{"nctId":"NCT03358082","phase":"PHASE1, PHASE2","title":"Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo","status":"UNKNOWN","sponsor":"Sohag University","startDate":"2017-10-01","conditions":"Vitiligo, 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Patients With Moderate to Severe Atopic Dermatitis","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2003-10","conditions":"Dermatitis, Atopic","enrollment":166},{"nctId":"NCT00560326","phase":"PHASE2","title":"Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2003-06","conditions":"Dermatitis, Atopic","enrollment":50},{"nctId":"NCT00691145","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2002-10","conditions":"Dermatitis, Atopic","enrollment":350},{"nctId":"NCT00689832","phase":"PHASE4","title":"Protopic Ointment in Children Atopic Eczema","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2004-02","conditions":"Dermatitis, 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Conjunctivitis","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":40,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Protopic 0.03%","Tarolimus ointment","Protopic® 0.03%","Protopic"],"phase":"marketed","status":"active","brandName":"Tacrolimus Ointment 0.03%","genericName":"Tacrolimus Ointment 0.03%","companyName":"Astellas Pharma Inc","companyId":"astellas","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation and cytokine production to reduce skin inflammation. Used for Atopic dermatitis (eczema), Vitiligo.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}