Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/17356
Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial
WOS ID: 000455202000006
Scopus EID: 2-s2.0-85054129997
Embase PUI: L624089143
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CitationMontoro V, Asensio C, Martinez A, Lorente J, Rodriguez FJ, Montojo J, et al. Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial. J Int Med Res. 2018 Oct;46(10):4050-60. Epub 2018 Aug 24.
Objectives: To assess the efficacy and safety of fluocinolone acetonide 0.025% otic solution versus placebo in treating patients with otic eczema. Methods: In this multicentre, randomized, double-blind, parallel-group phase 3 clinical trial, conducted at 12 Spanish centres between March 2012 and March 2013, patients received fluocinolone acetonide 0.025% or placebo otic solution twice daily for 7 days (days 1-7) with an 8-day follow-up (days 9-15). Outcome measures included change in itching from baseline (day 1) to study days 4-8 and 9-15, and change in otoscopic signs (erythema, oedema, and scaling) from baseline to the end of treatment (day 8) and end of follow-up (day 15). Results: Patients treated with fluocinolone acetonide 0.025% (n = 66), as compared with place-bo-treated patients (n = 69), showed significantly higher reductions in itching from baseline to study days 4-8 and 9-15, and in individual and global otoscopic signs from baseline to the end of treatment (day 8) and end of follow-up (day 15). Incidence and severity of adverse events was similar between the fluocinolone and placebo groups. Conclusions: Fluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema.
DeCSResultado del Tratamiento
Método Doble Ciego
Persona de Mediana Edad