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Post-marketing reports of drug-related hepatotoxicity, endocrine dysregulation and drug interactions resulted in market withdrawal of oral ketoconazole in some countries and strict relabeling in others.
Gupta, Daigle, Foley · Expert Opinion on Drug Safety (2015)
Drug-safety review of oral ketoconazole, the first FDA-approved broad-spectrum oral antifungal (1981)
Summarizes hepatotoxicity, adrenal/endocrine dysregulation, and serious CYP3A4 drug interactions
These risks drove the 2013 FDA/EMA restriction of systemic ketoconazole
Hair density and size and proportion of anagen follicles were improved almost similarly by both KCZ and minoxidil regimens ... there may be a significant action of KCZ upon the course of androgenic alopecia.
Piérard-Franchimont, De Doncker, Cauwenbergh, Piérard · Dermatology (1998)
Compared 2% ketoconazole shampoo with an unmedicated shampoo, with or without 2% minoxidil, in androgenic alopecia (no randomization stated)
Ketoconazole improved hair density, hair size, and the proportion of anagen follicles — almost similarly to the minoxidil regimen
Supports a Malassezia-driven inflammatory contribution to pattern hair loss that ketoconazole dampens
In an open, randomized study, hair growth was observed in all groups; the best results came from finasteride plus minoxidil, with finasteride-containing groups (including finasteride plus topical ketoconazole) showing statistically significant improvement (p<0.05).
Khandpur, Suman, Reddy · The Journal of Dermatology (2002)
Open, randomized, parallel-group study of 100 men with androgenetic alopecia
Compared oral finasteride, topical 2% minoxidil, and topical 2% ketoconazole shampoo, alone and in combination
Hair growth occurred in all groups; ketoconazole was used as an adjunct rather than a stand-alone treatment