Retrospective Analysis of the Real-World Use of Topical Antimicrobials in the Paediatric Population with Impetigo in Italy: Focus on the Role of Ozenoxacin 1% Cream.
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SUBMITTER: Barbieri E
PROVIDER: S-EPMC10047292 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature
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Retrospective Analysis of the Real-World Use of Topical Antimicrobials in the Paediatric Population with Impetigo in Italy: Focus on the Role of Ozenoxacin 1% Cream.
Barbieri Elisa E Cavagnis Sara S Boracchini Riccardo R Scamarcia Antonio A Testa Angela A Ciarniello Maria Grazia MG Martinelli Biancangela B Cantarutti Luigi L Giaquinto Carlo C Cantarutti Anna A
Children (Basel, Switzerland) 20230313 3
Using electronic data from a large population-based network of Family Paediatricians (Pedianet), we aimed to describe the use of topical antimicrobials, including ozenoxacin 1% cream, in impetigo in children in Italy. We included 2929 children aged 6 months-14 years from 2016 to 2019 with at least one episode of impetigo treated with topical antimicrobials. Overall, 3051 cases of impetigo were included in the analysis. Treatment started in most cases on the same day as the impetigo diagnosis and ...[more]
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Project description:BACKGROUND:Ozenoxacin is a topical antibiotic approved in Europe to treat non-bullous impetigo in adults and children aged ≥6 months. This analysis evaluated the efficacy and safety of ozenoxacin in paediatric patients by age group. METHODS:Pooled data for patients aged 6 months to <18 years who had participated in a phase I or in two phase III clinical trials of ozenoxacin 1% cream were analysed by age group: 0.5-<2, 2-<6, 6-<12, and 12-<18 years. RESULTS:The combined population comprised 529 patients with non-bullous impetigo treated with ozenoxacin (n = 239), vehicle (n = 201), or retapamulin as internal validation control (n = 89). Studies were well matched for extent and severity of impetigo and therapeutic schedule (twice daily application for 5 days). The clinical success rate after 5 days' treatment (day 6-7, end of therapy), and microbiological success rates after 3-4 days' treatment and at the end of therapy, were significantly higher with ozenoxacin than vehicle (p < 0.0001 for all comparisons). Clinical and bacterial eradication rates were higher with ozenoxacin than vehicle in each age group. No safety concerns were identified with ozenoxacin. One (0.3%) of 327 plasma samples exceeded the lower limit of quantification for ozenoxacin, but the low concentration indicated negligible systemic absorption. CONCLUSION:This combined analysis supports the efficacy and safety of ozenoxacin administered twice daily for 5 days. Ozenoxacin 1% cream is a new option to consider for treatment of non-bullous impetigo in children aged 6 months to <18 years.
| S-EPMC7257257 | biostudies-literature
Project description:Importance:Ozenoxacin, a novel topical antibacterial agent with potent bactericidal activity against gram-positive bacteria, has been developed as a cream with 1% active drug for the treatment of impetigo, a highly contagious bacterial skin infection. Objectives:To evaluate the efficacy, safety, and tolerability of ozenoxacin cream, 1%, after 5-day twice-daily topical treatment in patients with impetigo. Design, Setting, and Participants:This randomized, double-blind, vehicle-controlled clinical trial included patients 2 months or older with impetigo who were enrolled at centers in 6 countries from June 2, 2014, through May 30, 2015. Data were analyzed based on intention to treat from July 9 through July 22, 2015. Interventions:Patients were randomized 1:1 to receive topical ozenoxacin or placebo control. Main Outcomes and Measures:Efficacy was measured using the Skin Infection Rating Scale and microbiological culture. Safety and tolerability were also evaluated. Results:Among the 411 patients who received treatment (210 males [51.1%]; mean [SD] age, 18.6 [18.3] years), ozenoxacin demonstrated superior clinical success compared with placebo, which was evident after 5 days of therapy (112 of 206 [54.4%] vs 78 of 206 [37.9%]; P = .001). Ozenoxacin also demonstrated superior microbiological success compared with placebo after 2 days of therapy (109 of 125 [87.2%] vs 76 of 119 [63.9%]; P = .002). Ozenoxacin was well tolerated, with 8 of 206 patients experiencing adverse effects, with only 1 of these potentially related to the study treatment; none were serious. Conclusions and Relevance:Topical ozenoxacin is effective and well tolerated in the treatment of impetigo in patients 2 months and older. This effect is demonstrated by rapid onset of response and superior clinical and microbiological response compared with placebo. Topical ozenoxacin represents a novel option for the treatment of impetigo. Trial Registration:ClinicalTrials.gov Identifier: NCT02090764.
| S-EPMC6128489 | biostudies-literature
Project description:Ozenoxacin is a topical quinolone showing potent antimicrobial activities against Gram-negative and Gram-positive bacteria and is widely used for the treatment of inflammatory acne. However, the anti-inflammatory activities of ozenoxacin have not been examined so far. In the present study, we investigated the in vitro and in vivo anti-inflammatory effects of ozenoxacin. The production of interleukin (IL)-6 and IL-8 by human epidermal keratinocytes stimulated by heat-killed Cutibacterium acnes was significantly inhibited by ozenoxacin at concentrations from 1 to 30 μg ml-1. Likewise, the production of IL-6, IL-8, and tumor necrosis factor alpha by stimulated THP-1 cells, a human monocyte cell line, was inhibited by ozenoxacin at concentrations from 1 to 30 μg ml-1. The production of IL-1β by THP-1 was also inhibited by ozenoxacin at the concentration of 30 μg ml-1. Phosphorylation of the mitogen-activated protein kinases and degradation of IκB-α, an inhibitory factor of NF-κB in keratinocytes and THP-1 cells, was increased by stimulation with heat-killed C. acnes. Of these activated intracellular pathways, the p38 phosphorylation pathway was remarkably reduced by ozenoxacin in both keratinocytes and THP-1 cells. In addition, the application of 2% ozenoxacin suppressed the increase in the ear thickness of rats induced by an intracutaneous injection of heat-killed C. acnes. These findings suggest that ozenoxacin possesses an anti-inflammatory activity, which may contribute to its therapeutic effects on inflammatory acne.
| S-EPMC7056637 | biostudies-literature
Project description:BackgroundRuxolitinib cream is the first topical Janus kinase (JAK) inhibitor approved in the United States (US) for the treatment of mild to moderate atopic dermatitis and nonsegmental vitiligo. A postmarketing study with oral tofacitinib, approved for rheumatoid arthritis, triggered class warnings for JAK inhibitors, including risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Because ruxolitinib cream is indicated for inflammatory conditions, it is subject to the same warnings as oral JAK inhibitors in the US. Here, nearly 14,000 patient-years of postmarketing safety data from the first year following market approval of ruxolitinib cream were reviewed.MethodsThe Incyte global safety database (21 September 2021-20 September 2022) and US FDA Adverse Event Reporting System (as of 30 September 2022) were queried for adverse event (AE) reports received for ruxolitinib cream.ResultsThe search identified 294 postmarketing individual case safety reports containing 589 events, including four serious AEs and no fatal AEs. AEs (i.e., any unfavorable sign, symptom, or disease) representing >2% of all events included application site pain (n = 16), atopic dermatitis (n = 15), skin irritation (n = 15), scratch (n = 14), and condition aggravated (n = 13). The four serious AEs were skin cancer (n = 2), pericarditis, and thrombocytopenia (both n = 1), none of which had sufficient information to assess possible relatedness to ruxolitinib cream. Serious AEs associated with the class warnings for JAK inhibitors were not reported.ConclusionsPostmarketing safety data from the year following approval suggest ruxolitinib cream is generally well tolerated, without significant systemic AEs, and with a low incidence of application site reactions.
| S-EPMC10866801 | biostudies-literature
Project description:IntroductionThe objective of this study was to evaluate treatment patterns in patients with rheumatoid arthritis (RA), with a focus on the utilization of baricitinib, an oral highly selective Janus kinase 1 and 2 inhibitor, in an Italian real-world setting.MethodsThis observational retrospective analysis was based on data collected in selected Italian administrative databases. Patients aged ≥ 18 years with a diagnosis of RA defined by hospitalization discharge diagnosis (International Classification of Diseases, Ninth Revision, Clinical Modification code 714.0) or by disease exemption code 006 for RA in 2018 were included. The index date (ID) was defined as the date of first prescription for a drug indicated for RA during the inclusion period. Patients without a prescription for biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) before the ID were considered to be b/tsDMARD naïve. A further analysis was performed on patients only receiving baricitinib.ResultsA total of 41,290 RA patients were enrolled, of whom 55.6% were not treated with conventional synthetic DMARDs (csDMARDs) or b/tsDMARDs, 39.4% were receiving therapy with csDMARDs, and 5.0% were using b/tsDMARDs. In the latter group, 2.7% (n = 56) were receiving therapy with baricitinib. In 2018, 13.2% of csDMARD-treated patients switched to b/tsDMARDs, of whom 4.3% (n = 93) of these switched to baricitinib. In total, 149 patients (mean age ± standard deviation 57.6 ± 12.1; 12.8% male) had a baricitinib prescription, of whom 51% were b/tsDMARD naïve. At baseline, 61.7% of baricitinib users were receiving combination therapy with csDMARDs plus corticosteroids, 26.2% were receiving combination therapy with corticosteroids, and 8.1% were receiving combination therapy with csDMARDs; 4% were receiving baricitinib monotherapy. During follow-up, the proportion of patients receiving baricitinib monotherapy increased to 38.9%, while 26.9, 18.8, and 15.4% of baricitinib users received combination therapy with corticosteroids, csDMARDs plus corticosteroids, and csDMARDs, respectively.ConclusionThis study provides a current view of the treatment patterns in Italian patients with RA in a real-world setting of daily clinical practice, with a focus on baricitinib utilization.
| S-EPMC7410892 | biostudies-literature
Project description:Topical corticosteroids (TCs) are widely used to treat dermatological conditions such as eczema and psoriasis. It can be a safe and effective treatment when used appropriately. However, misguided information and corticosteroid phobia appear to contribute to inadequate adherence to therapy, leading to unsatisfactory treatment outcomes. Therefore, community pharmacists (CPs) are in a prime position to inform patients about the appropriate use of medicine. The aim of this study was to examine how the knowledge and perceptions of CPs, as well as other factors, associate CPs' patient counseling practice around the use of TCs. A structured, validated questionnaire was distributed to CPs in the Republic of Korea, and additional focus group discussions were implemented to obtain a deeper understanding of the survey findings. We analyzed the survey results by applying a modified knowledge-perception-practice model. In addition, we used path analysis to validate the model and assessed how knowledge level and perceptions of barriers affect CPs' counseling behavior. We ran a multiple regression to identify factors that associate CPs' practice levels. A total of 1018 surveys were analyzed. In general, respondents had sufficient knowledge to provide appropriate patient counseling on TC use. An increase in knowledge level positively associated the quality of practice, and more knowledge increased the perception of barriers that negatively associated patient counseling. Location in rural areas and pharmacists' perception of counseling barriers negatively associated the quality of practice. A higher level of knowledge, training in ADEs, higher proportion of OTC TC sales, and increased time for counseling positively associated the quality of practice. Therefore, minimizing barriers such as negative perceptions is very important in facilitating CPs' counseling practice around TC use.
| S-EPMC7390350 | biostudies-literature
Project description:Aim: To assess the clinical improvement after single dose topical application of 1% clotrimazole cream in otomycosis and follow up for recurrence at the end of first and the third month. Materials and Methods: A prospective observational study was carried out at Government Medical college hospital. Patients with KOH diagnosed fungal infection of external auditory canal were included in the study. After obtaining informed written consent from the participating patients, a detail clinical history was taken. Single topical application of 1% clotrimazole cream in otomycosis. The fungal debris was removed with the help of suction aspiration and dry mopping. A single topical application of 1% clotrimazole cream was applied under all aseptic precautions. On the 3rd day the applied cream was cleaned with help of suction under ear microscope. Patients were advised to follow up after one month and three months. During each follow up patients were assessed clinically and examined for residual fungal debris. Result: Otomycosis was seen predominantly in middle aged females, housewives and laborers by occupation. Earache was most common symptom seen in 65.2%. Unilateral involvement was seen in 89.3% cases. The most common organism isolated in otomycosis was Aspergillus niger. At the end of one month of treatment with a single dose of 1% clotrimazole cream, 102 (91.0%) patients were recovered and 10 (9.0%) patients were with persistence or recurrence of the symptoms. At the end of third month, the recovery rate was 84.8% and recurrence rate was 6.3%. Conclusion: Single topical application of 1% clotrimazole cream is effective in treating otomycosis.Supplementary informationThe online version contains supplementary material available at 10.1007/s12070-022-03206-x.
| S-EPMC9734867 | biostudies-literature
Project description:Little is known whether topical analgesic creams, whose natural products enter the blood stream after application, affect myocardial infarct size. Here we tested whether topical analgesic creams can trigger remote cardioprotection and the mechanism involved. Male Sprague Dawley rats were used for an in vivo rodent model consisting of 30 minutes left anterior descending coronary artery ischemia and 2 hours of reperfusion followed by infarct size assessment. The topical analgesic IcyHot, applied to the abdomen prior to ischemia, reduced myocardial infarct size versus control (41 ± 3* vs 62 ± 1, n= 6/group, *P < 0.001). In contrast, the topical analgesic creams Preparation H, Aspercreme Heat, or Tiger Balm did not alter infarct size. IcyHot, unlike Preparation H, increased circulating methyl salicylate levels during reperfusion (3.0 ± 0.6 vs 0.4 ± 0.2 mg/dL, n = 6, *P < 0.001, measured at the internal jugular vein). Methyl salicylate (10 μM) applied to isolated adult cardiac myocytes during reoxygenation reduced cell death when compared to vehicle (21% ± 2%* vs 30% ± 2% of trypan blue positive cells, n = 9/group, *P < 0.01). Further, treatment with the TRP ankyrin 1 (TRPA1) inhibitors TCS-5861528 (1 μM) or AP-18 (1 μM) blocked the methyl salicylate-induced protective effect in isolated adult cardiomyocytes. In intact rodents, either of the TRPA1 inhibitors (1 mg/kg, intravenous) given prior to IcyHot topical application blocked IcyHot-induced infarct size reduction. IcyHot also reduced infarct size when applied 24 hours prior to myocardial ischemia or during myocardial ischemia versus control. Together, these findings support IcyHot analgesic cream can trigger remote cardioprotection through releasing methyl salicylate into the bloodstream with cardioprotection occurring by a TRPA1-dependent mechanism.
| S-EPMC7719099 | biostudies-literature
Project description:IntroductionPsoriasis is estimated to affect 0.44-2.8% of the Indian population. Moisturizers are a key adjuvant psoriasis treatment strategy, but data regarding their effectiveness, safety and compliance pattern in an Indian context are lacking. Hence, this real-world study on an intensive plant-based butter moisturizing cream (Venusia ® Max) was conducted among Indian patients with psoriasis.MethodsThis was an observational, patient-reported outcomes (PRO) study in patients with psoriasis aged 18-75 years who were prescribed the cream in routine clinical practice, as per clinician's discretion, over 4 weeks. The primary outcome measure was improvement from baseline in quality of life assessed using the Dermatology Quality of Life Index (DLQI) at 4 weeks of the study period. The secondary outcome measures were improvement in dryness using the Dry Skin/Ichthyosis Area and Severity Index (DASI) score at 4 weeks, safety and compliance. The DLQI and DASI scores were recorded by the clinicians at baseline and after 2 (optional) and 4 weeks of starting the cream. Safety was assessed throughout the study.ResultsThe study included 400 patients from 9 outpatient dermatology centers across India. Of 400 patients, 384 completed the study. A significant reduction in both the mean DLQI score (66.7%; p < 0.001) and mean DASI score (84.6%; p < 0.001) was observed at week 4 after starting the cream vs. baseline in the overall population. Overall, the cream showed a good safety and compliance profile during the study period. There were no serious adverse events or deaths.ConclusionsThe evidence from the PRO study suggests that use of the intensive plant-based butter moisturizing cream in a real-world scenario has a noticeable impact on improving the quality of life and reducing the skin dryness associated with psoriasis over 4 weeks. The moisturizing cream may serve as a valuable adjuvant treatment option for the management of psoriasis.Trial registration numberCTRI/2017/03/008023.FundingDr. Reddy's Laboratories Ltd.
| S-EPMC6704203 | biostudies-literature
Project description:Inherited optic neuropathies affect around 1 in 10,000 people in England; in these conditions, vision is lost as retinal ganglion cells lose function or die (usually due to pathological variants in genes concerned with mitochondrial function). Emerging gene therapies for these conditions have emphasised the importance of early and expedient molecular diagnoses, particularly in the paediatric population. Here, we report our real-world clinical experience of such a population, exploring which children presented with the condition, how they were investigated and the time taken for a molecular diagnosis to be reached. A retrospective case-note review of paediatric inherited optic neuropathy patients (0-16 years) in the tertiary neuro-ophthalmology service at Moorfields Eye Hospital between 2016 and 2020 identified 19 patients. Their mean age was 9.3 ± 4.6 (mean ± SD) years at presentation; 68% were male, and 32% were female; and 26% had comorbidities, with diversity of ethnicity. Most patients had undergone genetic testing (95% (n = 18)), of whom 43% (n = 8) received a molecular diagnosis. On average, this took 54.8 ± 19.5 weeks from presentation. A cerebral MRI was performed in 70% (n = 14) and blood testing in 75% (n = 15) of patients as part of their workup. Continual improvement in the investigative pathways for inherited optic neuropathies will be paramount as novel therapeutics become available.
| S-EPMC10888158 | biostudies-literature