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Treatment of Basal Cell Carcinoma With Topical Itraconazole

By: Sarah Campen, PharmD
Posted: Tuesday, October 1, 2019

For patients with multiple basal cell carcinomas, safe and effective nonsurgical treatment options are limited. Oral itraconazole has been shown to be effective in treating basal cell carcinomas, but it is associated with a risk of liver dysfunction and congestive heart failure with long-term use. A study published as a research letter in JAMA Dermatology found that a formulation of topical itraconazole gel did not reduce GLI1 mRNA levels. However, the topical gel did effectively reduce the tumor area of lesions located on the back, although it was ultimately not statistically significant when considering all anatomic locations.

“Topical and oral itraconazole are associated with [basal cell carcinoma] shrinkage in mice, but topical penetration in humans is more difficult owing to a thicker epidermis,” explained Grace K. Sohn, MD, of Stanford University, California, and colleagues.

The open-label trial enrolled 6 patients with basal cell nevus syndrome (81 tumors) and 3 patients with high-frequency basal cell carcinomas (33 tumors)—defined as more than 3 lesions annually. Each patient contributed 1 basal cell carcinoma tumor at baseline for GLI1 mRNA measurements, 1 or more tumors for treatment with placebo gel twice daily, and 2 or more tumors for treatment with itraconazole 0.7% gel (the maximum soluble concentration) twice daily for 4 to 12 weeks.

Of the 114 tumors, 42 were treated with placebo; 65, with topical itraconazole;, and 7 lesions were biopsied for baseline GLI1 mRNA levels. There was no difference in the mean percent change in GLI1 mRNA levels between itraconazole and placebo groups at 4 weeks (132% vs. 19.0% from baseline), nor in the percent change in the tumor area between itraconazole and placebo at 4 weeks and 12 weeks.

Topical itraconazole was well tolerated, with only grade 1 and 2 adverse effects reported. They included application-site reaction, pruritus, lesion pain, dysgeusia, and xerosis.

Disclosure: The study authors’ disclosure information may be found at jamanetwork.com.



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