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

• Victoria Montoro ^[1] ; Carlos Asensio ^[2] ; Ángel Martínez ^[10] ; Juan Lorente ^[3] ; Francisco J. Rodríguez ^[4] ; José Montojo ^[5] ; Javier Gavilanes ^[6] ; Pedro Sarría ^[7] ; Cristóbal Langdon ^[8] ; Eduard Prades ^[9]
  1. [1] Fundació Hospital de Mollet

     Fundació Hospital de Mollet

     Moncada y Reixach, España

     
  2. [2] Hospital Nuestra Señora del Prado

     Hospital Nuestra Señora del Prado

     Talavera de la Reina, España

     
  3. [3] Hospital Vall d'Hebron

     Hospital Vall d'Hebron

     Barcelona, España

     
  4. [4] Hospital Santa María del Rosell

     Hospital Santa María del Rosell

     Cartagena, España

     
  5. [5] Hospital de Fuenlabrada

     Hospital de Fuenlabrada

     Fuenlabrada, España

     
  6. [6] Hospital Universitario de Torrejón

     Hospital Universitario de Torrejón

     Torrejón de Ardoz, España

     
  7. [7] Hospital Universitario Son Espases

     Hospital Universitario Son Espases

     Palma de Mallorca, España

     
  8. [8] Hospital Clinic Barcelona

     Hospital Clinic Barcelona

     Barcelona, España

     
  9. [9] Hospital Comarcal de Blanes

     Hospital Comarcal de Blanes

     Blanes, España

     
  10. [10] Otolaryngology Department,Hospital Virgen de la Salud, Toledo

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• Localización: Salux: revista de ciencias y humanidades, ISSN-e 2444-5304, Vol. 5, Nº. Extra 1, 2019 (Ejemplar dedicado a: Premios (Julio 2019)), págs. 6-7
• Idioma: inglés
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• Resumen

  • 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.