Dataset Information

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

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 for otic eczema.

SUBMITTER: Montoro V

PROVIDER: S-EPMC6166331 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 V Asensio Carlos C Martínez Ángel Á Lorente Juan J Rodríguez Francisco J FJ Montojo José J Gavilanes Javier J Sarría Pedro P Langdon Cristóbal C Prades Eduard E

The Journal of international medical research 20180824 10

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 ...[more]

PMID: 30141364

Similar Datasets

Project description:BackgroundNabiximols is a cannabis-based drug to treat spasticity-associated symptoms currently approved for patients with multiple sclerosis only. Cannabinoids are useful in an increasing number of medical conditions but may bear an increased risk for cardiovascular events. SativexStroke is a double-blind randomized placebo-controlled crossover monocentric clinical trial investigating the efficacy and safety of nabiximols in patients with spasticity following stroke.MethodsPatients were treated with nabiximols oromucosal spray or placebo and assessed before and after two phases of 1-month duration each. Cardiovascular safety was assessed before and during the trial. Primary endpoints were changes in spasticity numeric rating scale scores and electromyographic recording of the stretch reflex in affected wrist flexors. Secondary outcome measures were numeric rating scale scores for pain, sleep and bladder function, the number of daily spasms and clinical assessment of spasticity with the modified Ashworth scale. The study was registered with the EudraCT number 2016-001034-10.ResultsBetween May 2, 2018, and February 20, 2020, 41 patients entered the study. Seven patients did not complete the study, so 34 were included in the analysis. Two serious adverse events occurred, but none related to cardiovascular function. Primary and secondary efficacy outcome measures did not change from baseline during nabiximols treatment relative to placebo.ConclusionThis study suggests that nabiximols use is probably safe in stroke patients, therefore cannabinoid usefulness may be further investigated. The lack of nabiximols effect could be related to low pain levels in recruited patients or different spasticity mechanisms between post-stroke and multiple sclerosis patients. Similarly, a beneficial effect of nabiximols could have emerged if more patients with a higher level of spasticity at baseline were recruited.Clinical trial registrationhttps://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001034-10/IT.

Project description:BackgroundGlycyrrhizin is widely used in skin disorders, such as psoriasis, alopecia areata, and allergic diseases, but has not been extensively studied in patients with chronic eczema.ObjectiveTo evaluate the efficacy and safety of oral compound glycyrrhizin (OCG) plus topical corticosteroid (TCS) in adults with chronic eczema.MethodsThis was a multicenter, randomized, double-blind, placebo-controlled study in patients with chronic eczema (n = 199). Randomized participants from 6 centers in China received either 75 mg OCG capsules or placebo capsules three times a day and TCS (i.e., 0.1% mometasone furoate ointment) once a day for 28 days. Efficacy was determined by analyzing the mean change from the baseline using standardized measures including the Investigator's Global Assessment (IGA) score, Eczema Area and Severity Index (EASI), and the visual analogue scale score (VAS) of itching.ResultsDecreases in absolute EASI were significantly greater in the OCG-treated group versus placebo on day 14 (-3.41 ± 1.41 vs. -2.71 ± 1.25, P < 0.001) and day 28 (-7.39 ± 1.71 vs. -6.64 ± 1.75, P=0.003). OCG-treated patients also saw greater benefit in other EASI metrics including EASI-50 (96.8% vs. 87.9%, P=0.021) and EASI-75 (47.9% vs. 21.2%, P < 0.001) on day 28 compared with placebo. The absolute IGA score reductions were also significantly greater in the OCG group than the placebo (all P < 0.05). In addition, proportions of patients who achieve clear (0) IGA scores or almost clear (1) IGA scores were significantly higher in the treated group than placebo on day 14 (22.8% vs. 6.2%, P=0.001) and day 28 (93.5% vs. 79.4%, P=0.005). Moreover, the proportions of patients with reduced pruritus were significantly greater in the treated group than placebo on day 28 (94.7% vs. 83.8%, P=0.016) and eczema recurrence was notably less in the OCG group versus placebo (3.19% vs. 12.12%, P=0.021). Eleven patients experienced adverse events, but there was no significant difference in the proportion of patients affected (3.0% vs. 8.5%, P > 0.05). The most common adverse events were edema of both lower limbs.ConclusionFor adults with chronic eczema, OCG capsules combined with TCS is an effective and well-tolerated treatment, suggesting that OCG may be a useful nonsteroidal agent with an additional effect for the treatment of chronic eczema by TCS.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets