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

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 Mar...

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Autores principales: Montoro, Victoria, Asensio, Carlos, Martínez, Ángel, Lorente, Juan, Rodríguez, Francisco J., Montojo, José, Gavilanes, Javier, Sarría, Pedro, Langdon, Cristóbal, Prades, Eduard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6166331/
https://www.ncbi.nlm.nih.gov/pubmed/30141364
http://dx.doi.org/10.1177/0300060518765333
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author Montoro, Victoria
Asensio, Carlos
Martínez, Ángel
Lorente, Juan
Rodríguez, Francisco J.
Montojo, José
Gavilanes, Javier
Sarría, Pedro
Langdon, Cristóbal
Prades, Eduard
author_facet Montoro, Victoria
Asensio, Carlos
Martínez, Ángel
Lorente, Juan
Rodríguez, Francisco J.
Montojo, José
Gavilanes, Javier
Sarría, Pedro
Langdon, Cristóbal
Prades, Eduard
author_sort Montoro, Victoria
collection PubMed
description 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 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. CONCLUSIONS: Fluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema.
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spelling pubmed-61663312018-10-03 Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial Montoro, Victoria Asensio, Carlos Martínez, Ángel Lorente, Juan Rodríguez, Francisco J. Montojo, José Gavilanes, Javier Sarría, Pedro Langdon, Cristóbal Prades, Eduard J Int Med Res Clinical Research Reports 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 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. CONCLUSIONS: Fluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema. SAGE Publications 2018-08-24 2018-10 /pmc/articles/PMC6166331/ /pubmed/30141364 http://dx.doi.org/10.1177/0300060518765333 Text en © The Author(s) 2018 http://creativecommons.org/licenses/by-nc/4.0/ Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Clinical Research Reports
Montoro, Victoria
Asensio, Carlos
Martínez, Ángel
Lorente, Juan
Rodríguez, Francisco J.
Montojo, José
Gavilanes, Javier
Sarría, Pedro
Langdon, Cristóbal
Prades, Eduard
Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial
title Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial
title_full Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial
title_fullStr Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial
title_full_unstemmed Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial
title_short Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial
title_sort efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial
topic Clinical Research Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6166331/
https://www.ncbi.nlm.nih.gov/pubmed/30141364
http://dx.doi.org/10.1177/0300060518765333
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