Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial

Abstract

ObjectivesTo assess the efficacy and safety of fluocinolone acetonide 0.025% otic solution versus placebo in treating patients with otic eczema.MethodsIn 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).ResultsPatients treated with fluocinolone acetonide 0.025% (n = 66), as compared with placebo-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.ConclusionsFluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema.

Column Chromatographic Fractionated of <em>Gymnema inodorum</em> Leaves Extracted: Antioxidant Activity and Their Phenolic Profiles

“…Among the identified phenolic compounds, Zhebeiresinol a phenolic lignan has potential health benefits, including antioxidant and anti-inflammatory properties [33]. The compound Fluocinolone has been studied for treating localized psoriasis [34]. Furthermore Eudesmin is found in LC-QTOF/MS result, which is natural phenolic lignan having specific antioxidant and anti-inflammatory potential [35], while Clausarinol, Chamuvaritin and To-mentolide A seemed to be a new compounds with limited or no prior study.…”

Successful treatment of erythematous‐squamous disorders of the external auditory canal with tacrolimus and clotrimazole in otic oil: Our experience in 25 patients

“…Some patients even go to the emergency room (ER) for symptoms such as severe itching, or even hearing loss due to occlusion of the ear canal. Treatment with topical corticosteroids, 2 associated with topical antibiotics 3 are the most frequent prescription. However, its use is normally limited to 7 days.…”

Treatment of chronic resistant otitis externa with Fluticasone propionate (Flixonase®): initial experience

“…Results indicated that patients treated fluocinolone acetonide solutions (n= 58), compared with the placebotreated group (n= 63), had significantly higher reduction in itching (P < 0.001) and improvement in otoscopic signs (P < 0.001). (21) We have investigated the option of using Flixonase ® topically in 25 resistant cases. As presented in the section above, all cases who returned to follow up were classified as being cured and symptoms free.…”