Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia: An Open-Label Pilot Study.

Overview

abstract

BACKGROUND: Central centrifugal cicatricial alopecia (CCCA) is a scarring alopecia primarily affecting Black women. To date, there are no standardized treatment regimens or approved medications for the treatment of CCCA. This single-center, open-label, clinical study investigated the efficacy of apremilast in the treatment of mild to moderate vertex-predominant CCCA. METHODS: 20 adult female patients of African ancestry with mild to moderate vertex-predominant CCCA were treated in an open-label fashion with apremilast 30 mg orally twice daily for 24 weeks. RESULTS: 15 of 20 patients completed the study. At week 24, mean change in the physician global assessment of improvement (primary endpoint), investigator global severity score, and central hair loss grade was 0.235 (P=0.04), -0.31 (P=0.01), and -0.46 (P=0.08), respectively. Mean improvements were also seen in patient reported outcomes at week 24 including the patient global assessment of improvement 1.31 (P=0.01), visual analog of hair loss severity 1.85 (P=0.05), numerical rating scales for pruritus -2.31 (P=0.00), burning -0.46 (P=0.36), and pain -0.15 (P=0.61), as well as the dermatology life quality index -2.42 (P=0.09). LIMITATIONS: The sample size was small and underpowered to detect statistically significant changes in most secondary endpoints. Additionally, the COVID-19 pandemic interfered with the conduct of the study protocols. CONCLUSION: Apremilast was safe and moderately efficacious for the treatment of CCCA, with patients showing statistically significant improvements in several investigator and patient-reported outcomes. Larger, placebo-controlled studies investigating therapies for CCCA are warranted. Adverse events (AEs) were consistent with the known safety profile of apremilast and may limit the use of this medication in some patients.