Safety and efficacy of topical, fixed‐dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) gel in adolescent patients with scalp and body psoriasis: a phase II trial

摘要

Abstract Background Psoriasis is a disease that commonly manifests in adolescence. Up to half of adults with psoriasis develop it before the age of 20. Topical formulations containing corticosteroids and/or vitamin D3 analogs are recommended for treatment. Objective This phase II study aimed to evaluate the safety, including any potential effect on the hypothalamic–pituitary–adrenal axis and calcium metabolism, and efficacy of fixed‐dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) (Cal/ BD ) gel in adolescents with psoriasis. Methods Patients aged 12 to 17?years, with at least mild psoriasis on the body and scalp, received topical Cal/ BD gel once daily for ≤8?weeks. Safety response criteria included adverse drug reactions [ ADR s; any adverse event ( AE ) possibly or probably related to treatment as determined by the investigator; a primary response criterion] and AE s (a secondary response criterion). Only treatment‐emergent AE s (events that occurred after the first application of Cal/ BD gel or events which started before this and increased in intensity after the first application of Cal/ BD gel) are presented here. Efficacy response criteria included controlled disease, by physician's global assessment of disease severity ( PGA ), following Cal/ BD gel treatment. Results A total of 107 patients (median age 14?years; range 12–16) were enrolled and treated. Eight ADR s were observed in 7 (7%) patients and 38 (36%) patients experienced ≥1 AE . The most common AE s were headache [6 (6%) patients], nasopharyngitis [6 (6%) patients] and blood parathyroid hormone increased [4 (4%) patients]. One severe AE was reported (attempted suicide) but was considered unrelated to treatment. At the end of treatment, 58% of patients had controlled disease on the body and 69% on the scalp according to PGA . Conclusion In this uncontrolled phase II study, Cal/ BD gel was well tolerated and effective for treating scalp and body psoriasis in adolescents.