Safety and efficacy of fixed-dose combination calcipotriol (50 μg/g) and betamethasone dipropionate (0.5 mg/g) cutaneous foam in adolescent patients (aged 12 to <17 years) with plaque psoriasis: results of a phase II, open-label trial.

ABSTRACT:

Background

Fixed-dose combination of calcipotriol (50 μg/g; Cal) and betamethasone dipropionate (0.5 mg/g; BD) foam is approved for plaque psoriasis treatment in adults, with a paucity of data supporting use in adolescents.

Objectives

To evaluate safety of 4 weeks' treatment with Cal/BD foam in adolescent patients with psoriasis, and additional safety outcomes in patients with more severe disease (HPA-axis cohort). Primary objectives included treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio in the HPA-axis cohort. Secondary objectives included exploratory efficacy endpoints [treatment success: change in Psoriasis Area and Severity Index (PASI)].

SUBMITTER: Seyger M 

PROVIDER: S-EPMC7496170 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature