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

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)]. Systemic exposure to Cal/BD was also assessed. METHODS: A phase II, open‐label, study (NCT02387853) in patients (12 to <17 years) with at least mild psoriasis, to evaluate Cal/BD foam applied once daily for ≤4 weeks. RESULTS: In patients assigned to treatment (n = 106), 32 TEAEs occurred in 22 patients (20.8%). All but two TEAEs were mild; none led to study withdrawal or death. Changes (0–4 weeks) in albumin‐corrected serum calcium (overall population) and urinary calcium excretion (HPA‐axis cohort) were small, transient and not considered clinically relevant. In the HPA‐axis cohort, no change in urinary calcium:creatinine ratio was observed and responses to adrenocorticotropic–hormone (ACTH) challenge did not suggest disruption of the HPA‐axis. Prespecified treatment success on the body and scalp was achieved by 71.8% and 75.7% of the overall population, respectively. Mean PASI decreased by 82.0% vs. baseline at Week 4. Systemic exposure to Cal/BD was minimal. CONCLUSIONS: Cal/BD foam was well tolerated in adolescent patients with body/scalp psoriasis. There was no evidence for dysregulation of the HPA‐axis nor calcium homoeostasis in patients with more severe disease. Exploratory efficacy data in the overall population were encouraging.