Characterizing local and systemic exposure to clobetasol propionate in healthy subjects and patients with atopic dermatitis.

ABSTRACT:

Aims

There is a potential risk of systemic side-effects with the use of potent corticosteroids, such as clobetasol propionate (CP). This concern is of particular interest in paediatric patients. The aim of this study was to develop and verify a physiologically based pharmacokinetic (PBPK) model to describe the local and systemic exposure to CP following topical application over a period of up to 4 weeks.

Methods

Data from 12 clinical studies in healthy adult subjects and patients with atopic dermatitis (AD) were available for this investigation. A PBPK model including skin barrier impairment was developed to predict the effect of AD lesions on systemic exposure. Simulation scenarios were then evaluated to assess the effect of formulation, skin condition and surface area (5%-

SUBMITTER: Duong JK 

PROVIDER: S-EPMC12569561 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature