Evaluating the Safety and Efficacy of Sirolimus Topical Gel 0.2% to Treat Acanthosis Nigricans

Acanthosis nigricans (AN) is a common cutaneous disorder characterized by hyperpigmented, velvety plaques, typically in flexural areas such as the neck, axillae, and groin. In the United States, its prevalence may be as high as 19.4% and disproportionately impacts individuals with skin of color, with African Americans 25 times more likely to be diagnosed with AN than Caucasians.^1-4 Extrapolating these findings to a global population that now exceeds 8 billion, it is estimated that over 155 million individuals could be impacted by AN. Beyond its prevalence, AN underscores a significant healthcare concern as well as a potential health equity issue. Individuals with AN often report substantial decreases in self-esteem and concomitant increases in depression and anxiety, underscoring the need for effective, readily accessible treatments that improve both the physical and psychosocial aspects of the condition.^1,5,6 Despite the global rise in AN prevalence, there are currently no FDA-approved pharmacotherapies available for its treatment.⁷

In addition to its association with insulin resistance and obesity, AN can serve as a paraneoplastic marker and has been linked to various endocrine disorders, further emphasizing the multifaceted etiology and clinical importance of this condition.^8,9 Large-scale studies have reinforced its strong correlation with hyperinsulinemia, type 2 diabetes, and metabolic syndrome, highlighting the necessity for both dermatologic and systemic evaluation.^10,11 The American Diabetes Association thus recommends thorough metabolic screening when AN is diagnosed, given its role as a clinical marker of potential insulin resistance and cardiovascular risk.¹⁰