{"id":"topical-ketoconazole-2-cream","safety":{"commonSideEffects":[{"rate":null,"effect":"Local irritation, burning, or stinging at application site"},{"rate":null,"effect":"Erythema or rash"},{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Contact dermatitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ketoconazole is an imidazole antifungal that blocks the demethylation of lanosterol by inhibiting fungal CYP51, a key step in ergosterol biosynthesis. This disrupts the integrity and permeability of the fungal cell membrane, leading to leakage of cellular contents and fungal cell death. The topical 2% cream formulation delivers high local concentrations to the skin while minimizing systemic absorption.","oneSentence":"Ketoconazole inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in the fungal cell membrane and causing cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:13:19.145Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tinea corporis (ringworm of the body)"},{"name":"Tinea cruris (jock itch)"},{"name":"Tinea pedis (athlete's foot)"},{"name":"Pityriasis versicolor"},{"name":"Cutaneous candidiasis"},{"name":"Seborrheic dermatitis"}]},"trialDetails":[{"nctId":"NCT03437005","phase":"PHASE1","title":"Alternation in the Human Microbiome With Commonly Used Topical Medications","status":"RECRUITING","sponsor":"University of California, Davis","startDate":"2013-01-28","conditions":"Healthy","enrollment":24},{"nctId":"NCT07333170","phase":"PHASE4","title":"Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor.","status":"NOT_YET_RECRUITING","sponsor":"PAEC General Hospital, Islamabad","startDate":"2026-02","conditions":"Pityriasis Versicolor","enrollment":86},{"nctId":"NCT07237763","phase":"NA","title":"Assessment of the Efficacy of Topical Ketoconazole 2% Cream in Comparison With Topical Retinoids in the Treatment of Mild Comedonal and Papulopustular Acne","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cairo University","startDate":"2024-01-15","conditions":"Acne","enrollment":52},{"nctId":"NCT04203342","phase":"PHASE3","title":"A Therapeutic Equivalence Study of Ketoconazole Cream 2%","status":"COMPLETED","sponsor":"Douglas Pharmaceuticals America Ltd","startDate":"2019-12-11","conditions":"Tinea Pedis","enrollment":682},{"nctId":"NCT03320486","phase":"PHASE3","title":"Non-inferiority Trial of Dapaconazole Versus Ketoconazole","status":"COMPLETED","sponsor":"Biolab Sanus Farmaceutica","startDate":"2017-11-01","conditions":"Tinea Pedis","enrollment":360},{"nctId":"NCT03688971","phase":"PHASE2","title":"Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis","status":"UNKNOWN","sponsor":"Maruho Co., Ltd.","startDate":"2018-10-22","conditions":"Seborrheic Dermatitis","enrollment":36},{"nctId":"NCT03178994","phase":"PHASE3","title":"The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne","status":"COMPLETED","sponsor":"Chulalongkorn University","startDate":"2017-08-01","conditions":"Post - Adolescence Acne","enrollment":42},{"nctId":"NCT02606383","phase":"PHASE3","title":"Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis","status":"WITHDRAWN","sponsor":"Biolab Sanus Farmaceutica","startDate":"2016-06","conditions":"Tinea Pedis","enrollment":""},{"nctId":"NCT02824926","phase":"PHASE2","title":"Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis","status":"COMPLETED","sponsor":"Gilberto De Nucci","startDate":"2014-07","conditions":"Tinea Pedis","enrollment":60},{"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}],"_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":[],"phase":"marketed","status":"active","brandName":"Topical ketoconazole 2% cream","genericName":"Topical ketoconazole 2% cream","companyName":"PAEC General Hospital, Islamabad","companyId":"paec-general-hospital-islamabad","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ketoconazole inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in the fungal cell membrane and causing cell death. Used for Tinea corporis (ringworm of the body), Tinea cruris (jock itch), Tinea pedis (athlete's foot).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}