{"id":"ketoconazole-2-shampoo","safety":{"commonSideEffects":[{"rate":null,"effect":"Scalp irritation"},{"rate":null,"effect":"Dryness"},{"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 fungal enzyme lanosterol 14α-demethylase (CYP51), a key step in ergosterol biosynthesis. This disrupts the integrity of the fungal cell membrane, leading to leakage of cellular contents and fungal cell death. The 2% shampoo formulation delivers the drug topically to the scalp for local antifungal activity.","oneSentence":"Ketoconazole inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in fungal cell membranes and causing cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:51:04.765Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Seborrheic dermatitis of the scalp"},{"name":"Dandruff"},{"name":"Tinea versicolor (pityriasis versicolor)"},{"name":"Malassezia-related scalp conditions"}]},"trialDetails":[{"nctId":"NCT07471178","phase":"PHASE4","title":"Mycological Efficacy and Safety of Ketoconazole 2% Shampoo With a Seven-Day Versus Three-Day Treatment Duration in Pityriasis Versicolor","status":"NOT_YET_RECRUITING","sponsor":"Fakultas Kedokteran Universitas Indonesia","startDate":"2026-02","conditions":"Pityriasis Versicolor","enrollment":76},{"nctId":"NCT06170333","phase":"PHASE4","title":"8% Sulphur-Aloe Vera Soap as an Adjuvant Treatment for Pityriasis Versicolor","status":"COMPLETED","sponsor":"Universitas Padjadjaran","startDate":"2023-08-25","conditions":"Pityriasis Versicolor","enrollment":42},{"nctId":"NCT06305637","phase":"PHASE1","title":"A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor.","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2023-12-04","conditions":"Tinea Versicolor","enrollment":430},{"nctId":"NCT03845348","phase":"PHASE3","title":"To Evaluate the Efficacy and Safety of Shampoo TD03 and TD07 in Scalp Diseases","status":"UNKNOWN","sponsor":"Sao Thai Duong Joint Stock Company","startDate":"2019-05-22","conditions":"Scalp Dermatitis","enrollment":366},{"nctId":"NCT04057950","phase":"NA","title":"Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic Dermatitis","status":"COMPLETED","sponsor":"L'Oreal","startDate":"2019-06-01","conditions":"Scalp Dermatitis, Dermatitis","enrollment":80},{"nctId":"NCT00862654","phase":"PHASE3","title":"Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2009-03","conditions":"Scalp Seborrheic Dermatitis","enrollment":326},{"nctId":"NCT04007237","phase":"PHASE4","title":"The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial","status":"COMPLETED","sponsor":"Indonesia University","startDate":"2018-09-01","conditions":"Pityriasis Versicolor","enrollment":100},{"nctId":"NCT01203189","phase":"NA","title":"Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo","status":"COMPLETED","sponsor":"St. Louis University","startDate":"2010-09","conditions":"Seborrheic Dermatitis","enrollment":23},{"nctId":"NCT00127868","phase":"NA","title":"Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)","status":"COMPLETED","sponsor":"Chen, Catherine, M.D.","startDate":"2005-03","conditions":"Tinea Capitis","enrollment":47}],"_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":["Nizoral"],"phase":"marketed","status":"active","brandName":"Ketoconazole 2% Shampoo","genericName":"Ketoconazole 2% Shampoo","companyName":"Fakultas Kedokteran Universitas Indonesia","companyId":"fakultas-kedokteran-universitas-indonesia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ketoconazole inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in fungal cell membranes and causing cell death. Used for Seborrheic dermatitis of the scalp, Dandruff, Tinea versicolor (pityriasis versicolor).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}