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

The Journal of International Medical Research
Victoria MontoroEduard Prades

Abstract

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 ...Continue Reading

References

Jan 1, 1979·The Journal of International Medical Research·A Buch-Rasmussen
Dec 1, 1991·Clinical Otolaryngology and Allied Sciences·G D Barr, M al-Khabori
Jan 1, 1991·European Archives of Oto-rhino-laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery·S JacobssonC Schrewelius
Aug 10, 2002·Clinical Otolaryngology and Allied Sciences·S SoodG I Stables
Mar 29, 2003·Journal of the American Academy of Dermatology·Amy S PallerLawrence F Eichenfield
Mar 11, 2004·American Journal of Otolaryngology·Murat YariktasMustafa Demirci
Apr 6, 2004·The Veterinary Clinics of North America. Small Animal Practice·Edmund J Rosser
Mar 15, 2005·The Journal of Dermatological Treatment·M PauporteR Ramirez
Sep 25, 2008·HNO·A NeherA W Scholtz
Aug 2, 2011·Current Opinion in Otolaryngology & Head and Neck Surgery·Bradley W Kesser
Jan 18, 2013·Therapeutic Delivery·E HoskisonJ P Birchall
Jun 13, 2013·American Journal of Clinical Dermatology·Kam Lun HonBenjamin Barankin
Sep 24, 2016·Clinical Ophthalmology·Stephen G SchwartzHarry W Flynn

❮ Previous
Next ❯

Citations


❮ Previous
Next ❯

Clinical Trials Mentioned

NCT01996748

Software Mentioned

SAS

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.