Safety and efficacy of calcipotriol plus betamethasone dipropionate gel in the treatment of scalp psoriasis in adolescents 12-17 years of age

Summary Background Plaque psoriasis has a relatively high prevalence in adolescence, resulting in a significant impact on quality of life, including social interactions. Objectives The primary objective was to assess the safety of once‐daily application of fixed‐combination calcipotriol plus betamethasone dipropionate gel in adolescent scalp psoriasis. Assessment of efficacy was a secondary objective. Methods This phase II, multicentre, single‐arm, open‐label, 8‐week trial included patients aged 12–17 years with moderate‐to‐very severe scalp psoriasis according to Investigator's Global Assessment (IGA) (≥ 10% of the scalp area affected). Results Seventy‐eight patients received treatment. Twenty‐seven patients (35%) reported a total of 64 adverse events (AEs); most were mild (33/64) or moderate (22/64) in severity and there were no serious AEs. No cases of hypercalcaemia were reported, and the mean changes from baseline to end of treatment in albumin‐corrected serum calcium (0·00 mmol L−1), 24‐h urinary calcium excretion (−0·03 mmol per 24 h) and urinary calcium‐to‐creatinine ratio (−0·12 mmol g−1) were not considered clinically relevant. At the end of treatment 66 patients (85%) were clear or almost clear according to IGA. There was an 80% improvement in mean Total Sign Score from baseline to end of treatment. In total, at the end of treatment, 87% of patients rated their scalp psoriasis as clear or very mild, and 75 (96%) had no or mild pruritus compared with 14 (18%) at baseline. Conclusions Once‐daily calcipotriol plus betamethasone dipropionate gel is well tolerated and efficacious for scalp psoriasis in adolescents. What's already known about this topic? Calcipotriol plus betamethasone dipropionate gel is a well‐tolerated and efficacious treatment for scalp and body psoriasis in adults. Psoriasis can present during childhood or adolescence and may negatively impact quality of life. What does this study add? Calcipotriol plus betamethasone dipropionate gel is well tolerated and shows efficacy for treatment of scalp psoriasis in an adolescent population.