{"id":"miconazole-nitrate-2","safety":{"commonSideEffects":[{"rate":null,"effect":"Local irritation or burning at application site"},{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Contact dermatitis"}]},"_chembl":{"chemblId":"CHEMBL1559","moleculeType":"Small molecule","molecularWeight":"479.15"},"_dailymed":{"setId":"4dbc521c-2f5f-9736-e063-6294a90ad85d","title":"HERMON JOCK ITCH ANTIFUNGAL TREATMENT CREAM (MICONAZOLE NITRATE 2%) CREAM [BEAUTIVITY LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Miconazole is an imidazole antifungal that inhibits the fungal cytochrome P450 enzyme lanosterol 14α-demethylase, blocking the conversion of lanosterol to ergosterol. This disrupts the fungal cell membrane structure and permeability, ultimately causing fungal cell death. It is effective against a broad spectrum of dermatophytes, yeasts, and other fungi.","oneSentence":"Miconazole nitrate disrupts fungal cell membrane integrity by inhibiting ergosterol synthesis, leading to cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:59:28.186Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Topical fungal infections (dermatophytosis, candidiasis, tinea pedis, tinea corporis, tinea cruris)"},{"name":"Pityriasis versicolor"}]},"trialDetails":[{"nctId":"NCT07311759","phase":"PHASE3","title":"Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cairo University","startDate":"2024-08-17","conditions":"Chronic Paronychia","enrollment":21},{"nctId":"NCT06869681","phase":"PHASE4","title":"Efficacy of Tropical Sertaconazole Nitrate 2% Vs Clotrimazole 1% for Tinea Pedis","status":"NOT_YET_RECRUITING","sponsor":"Jinnah Postgraduate Medical Centre","startDate":"2025-03-01","conditions":"Tinea Pedis","enrollment":100},{"nctId":"NCT06681090","phase":"PHASE1","title":"Different Treatment Modalities for Oral Lichen Plan","status":"COMPLETED","sponsor":"Al-Azhar University","startDate":"2023-03-03","conditions":"Oral Lichen Planus","enrollment":20},{"nctId":"NCT05660382","phase":"PHASE3","title":"Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis","status":"RECRUITING","sponsor":"Hill Dermaceuticals, Inc.","startDate":"2023-03-02","conditions":"Otomycosis","enrollment":100},{"nctId":"NCT04432376","phase":"PHASE2, PHASE3","title":"Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)","status":"COMPLETED","sponsor":"Hill Dermaceuticals, Inc.","startDate":"2020-07-08","conditions":"Otomycosis","enrollment":382},{"nctId":"NCT03130738","phase":"PHASE2","title":"Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis","status":"COMPLETED","sponsor":"Hill Dermaceuticals, Inc.","startDate":"2017-04-20","conditions":"Otomycosis","enrollment":65},{"nctId":"NCT04813822","phase":"PHASE2","title":"Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis","status":"UNKNOWN","sponsor":"Aesculape CRO Belgium BV","startDate":"2021-09-13","conditions":"Acute Vulvovaginal Candidiasis","enrollment":90},{"nctId":"NCT04442633","phase":"NA","title":"Glutamine With Topical Corticosteroids for Lichen Planus Treatment","status":"COMPLETED","sponsor":"Hams Hamed Abdelrahman","startDate":"2019-04-01","conditions":"Lichen Penis Planus","enrollment":30},{"nctId":"NCT03572959","phase":"PHASE4","title":"Management of Pain in Oral Lichen Planus","status":"COMPLETED","sponsor":"Sherine Adel Nasry","startDate":"2016-12-27","conditions":"Oral Lichen Planus","enrollment":24},{"nctId":"NCT03359070","phase":"PHASE2","title":"Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris","status":"COMPLETED","sponsor":"Galeno Desenvolvimento de Pesquisas Clínicas","startDate":"2014-01-29","conditions":"Tinea Cruris","enrollment":51},{"nctId":"NCT02545452","phase":"PHASE1","title":"Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring","status":"COMPLETED","sponsor":"Bayer","startDate":"2015-09-15","conditions":"Endometriosis","enrollment":52},{"nctId":"NCT02443311","phase":"PHASE4","title":"Clinical and Immunohistochemical Effect of Topical Pimecrolimus in Treatment of Oral Lichen Planus","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2010-09","conditions":"Oral Lichen Planus","enrollment":24},{"nctId":"NCT01661556","phase":"PHASE4","title":"Clinical Trial of Hydroquinone Versus Miconazol in Melasma","status":"UNKNOWN","sponsor":"Universidad Autonoma de San Luis Potosí","startDate":"2011-10","conditions":"Melasma","enrollment":60},{"nctId":"NCT01230814","phase":"PHASE2","title":"Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2011-04","conditions":"Bacterial Vaginosis, Candidiasis, Trichomoniasis","enrollment":234},{"nctId":"NCT01110330","phase":"PHASE3","title":"An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot","status":"TERMINATED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2007-07","conditions":"Tinea Pedis","enrollment":583},{"nctId":"NCT00702507","phase":"PHASE4","title":"Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants","status":"COMPLETED","sponsor":"Stiefel, a GSK Company","startDate":"2007-05","conditions":"Diaper Rash","enrollment":200},{"nctId":"NCT00741845","phase":"PHASE3","title":"Prevention of Persistence of Bacterial Vaginosis","status":"TERMINATED","sponsor":"Embil Pharmaceutical Co. Ltd","startDate":"2008-06","conditions":"Bacterial Vaginosis","enrollment":117}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":29,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Miconazole Nitrate 2%","genericName":"Miconazole Nitrate 2%","companyName":"Aesculape CRO Belgium BV","companyId":"aesculape-cro-belgium-bv","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Miconazole nitrate disrupts fungal cell membrane integrity by inhibiting ergosterol synthesis, leading to cell death. Used for Topical fungal infections including tinea pedis, tinea corporis, tinea cruris, and candidiasis, Pityriasis versicolor.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}