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Research Letter
July 24, 2019

Topical Itraconazole for the Treatment of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome or High-Frequency Basal Cell Carcinomas: A Phase 2, Open-Label, Placebo-Controlled Trial

Author Affiliations
  • 1Department of Dermatology, Stanford University, Stanford, California
  • 2Program in Epithelial Biology, Stanford University School of Medicine, Stanford, California
JAMA Dermatol. 2019;155(9):1078-1080. doi:10.1001/jamadermatol.2019.1541

Nonsurgical therapies are needed for patients with multiple basal cell carcinomas (BCCs). Vismodegib reduces BCCs but causes severe adverse effects and cannot be formulated as a topical treatment.1,2 Oral itraconazole is a weaker hedgehog (HH) pathway inhibitor and has shown evidence of reduced BCCs in Ptch1+/− mice and in 1 phase 2 trial.3-5 However, the risks of long-term treatment with oral itraconazole include liver dysfunction and congestive heart failure. We developed a topical itraconazole gel at the maximum soluble concentration that showed high dermal concentrations. In mice, itraconazole, 0.7%, gel reduced BCCs, showed no skin irritation, and achieved less than 1/100th the plasma level compared with oral itraconazole.4 Thus, we initiated a phase 2 trial evaluating itraconazole, 0.7%, gel vs placebo gel in patients with multiple BCCs.