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Journal of Cosmetic Dermatology Feb 2024Frontal fibrosing alopecia (FFA) is a cicatricial alopecia with rapid epidemic growth. However, there is no agreement on the best therapeutic approach. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Frontal fibrosing alopecia (FFA) is a cicatricial alopecia with rapid epidemic growth. However, there is no agreement on the best therapeutic approach.
AIMS
To compare the therapeutic effects of finasteride as a first-line systemic treatment of FFA versus hydroxychloroquine as a relatively safe and effective immunosuppressive drug.
METHODS
Thirty-four female FFA patients were randomly assigned to receive either 400 mg/day of hydroxychloroquine or 2.5 mg/day of finasteride for 6 months. Topical treatments in both groups include pimecrolimus, mometasone, and minoxidil. Treatment efficacy was evaluated using the Frontal Fibrosing Alopecia Severity Score (FFASS), photography, and trichoscopy after 3 and 6 months.
RESULTS
Both the finasteride and hydroxychloroquine groups showed significant improvements in FFASS and trichoscopic scores (p < 0.01). However, there was no significant difference between the two groups during the study. Photographic assessment showed that more than 60% of patients in both groups had improved without statistically significant differences between the two groups.
CONCLUSIONS
Both finasteride and hydroxychloroquine are equally effective, safe, and well-tolerable for treating FFA patients.
Topics: Humans; Female; Finasteride; Hydroxychloroquine; Alopecia; Treatment Outcome; Minoxidil; Lichen Planus
PubMed: 37691183
DOI: 10.1111/jocd.15993 -
The Cochrane Database of Systematic... Dec 2023Otitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. The fluid may cause hearing loss. Although most...
BACKGROUND
Otitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. The fluid may cause hearing loss. Although most episodes of OME in children resolve spontaneously within a few months, when persistent it may lead to behavioural problems and a delay in expressive language skills. Management of OME includes watchful waiting, medical, surgical and other treatments, such as autoinflation. Oral or topical steroids are sometimes used to reduce inflammation in the middle ear.
OBJECTIVES
To assess the effects (benefits and harms) of topical and oral steroids for OME in children.
SEARCH METHODS
We searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, Web of Science, ClinicalTrials.gov, ICTRP and additional sources for published and unpublished studies on 20 January 2023.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-randomised trials in children aged 6 months to 12 years with unilateral or bilateral OME. We included studies that compared topical or oral steroids with either placebo or watchful waiting (no treatment).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes, determined by a multi-stakeholder prioritisation exercise, were: 1) hearing, 2) OME-specific quality of life and 3) systemic corticosteroid side effects. Secondary outcomes were: 1) presence/persistence of OME, 2) other adverse effects (including local nasal effects), 3) receptive language skills, 4) speech development, 5) cognitive development, 6) psychosocial outcomes, 7) listening skills, 8) generic health-related quality of life, 9) parental stress, 10) vestibular function and 11) episodes of acute otitis media. We used GRADE to assess the certainty of evidence. Although we included all measures of hearing assessment, the proportion of children who returned to normal hearing was our preferred method to assess hearing, due to challenges in interpreting the results of mean hearing thresholds.
MAIN RESULTS
We included 26 studies in this review (2770 children). Most studies of oral steroids used prednisolone for 7 to 14 days. Studies of topical (nasal) steroids used various preparations (beclomethasone, fluticasone and mometasone) for between two weeks and three months. All studies had at least some concerns regarding risk of bias. Here we report our primary outcomes and main secondary outcome, at the longest reported follow-up. Oral steroids compared to placebo Oral steroids probably result in little or no difference in the proportion of children with normal hearing after 12 months (69.7% of children with steroids, compared to 61.1% of children receiving placebo, risk ratio (RR) 1.14, 95% confidence interval (CI) 0.97 to 1.33; 1 study, 332 participants; moderate-certainty evidence). There is probably little or no difference in OME-related quality of life (mean difference (MD) in OM8-30 score 0.07, 95% CI -0.2 to 0.34; 1 study, 304 participants; moderate-certainty evidence). Oral steroids may reduce the number of children with persistent OME at 6 to 12 months, but the size of the effect was uncertain (absolute risk reduction ranging from 13.3% to 45%, number needed to treat (NNT) of between 3 and 8; low-certainty evidence). The evidence was very uncertain regarding the risk of systemic corticosteroid side effects, and we were unable to conduct any meta-analysis for this outcome. Oral steroids compared to no treatment Oral steroids may result in little or no difference in the persistence of OME after three to nine months (74.5% children receiving steroids versus 73% of those receiving placebo; RR 1.02, 95% CI 0.89 to 1.17; 2 studies, 258 participants; low-certainty evidence). The evidence on adverse effects was very uncertain. We did not identify any evidence on hearing or disease-related quality of life. Topical (intranasal) steroids compared to placebo We did not identify data on the proportion of children who returned to normal hearing. However, the mean change in hearing threshold after two months was -0.3 dB lower (95% CI -6.05 to 5.45; 1 study, 78 participants; very low-certainty evidence). The evidence suggests that nasal steroids make little or no difference to disease-specific quality of life after nine months (OM8-30 score, MD 0.05 higher, 95% CI -0.36 to 0.46; 1 study, 82 participants; low-certainty evidence). The evidence is very uncertain regarding the effect of nasal steroids on persistence of OME at up to one year. Two studies reported this: one showed a potential benefit for nasal steroids, the other showed a benefit with placebo (2 studies, 206 participants). The evidence was also very uncertain regarding the risk of corticosteroid-related side effects, as we were unable to provide a pooled effect estimate. Topical (intranasal) steroids compared to no treatment We did not identify data on the proportion of children who returned to normal hearing. However, the mean difference in final hearing threshold after four weeks was 1.95 dB lower (95% CI -3.85 to -0.05; 1 study, 168 participants; low-certainty evidence). Nasal steroids may reduce the persistence of OME after eight weeks, but the evidence was very uncertain (58.5% of children receiving steroids, compared to 81.3% of children without treatment, RR 0.72, 95% CI 0.57 to 0.91; 2 studies, 134 participants). We did not identify any evidence on disease-related quality of life or adverse effects.
AUTHORS' CONCLUSIONS
Overall, oral steroids may have little effect in the treatment of OME, with little improvement in the number of children with normal hearing and no effect on quality of life. There may be a reduction in the proportion of children with persistent disease after 12 months. However, this benefit may be small and must be weighed against the potential for adverse effects associated with oral steroid use. The evidence for nasal steroids was all low- or very low-certainty. It is therefore less clear if nasal steroids have any impact on hearing, quality of life or persistence of OME. Evidence on adverse effects was very limited. OME is likely to resolve spontaneously for most children. The potential benefit of treatment may therefore be small and should be balanced with the risk of adverse effects. Future studies should aim to determine which children are most likely to benefit from treatment, rather than offering interventions to all children.
Topics: Child; Child, Preschool; Humans; Administration, Intranasal; Adrenal Cortex Hormones; Anti-Bacterial Agents; Otitis Media with Effusion; Steroids
PubMed: 38088821
DOI: 10.1002/14651858.CD015255.pub2 -
Molecules (Basel, Switzerland) Nov 2023Mometasone furoate is a synthetic corticosteroid used in the treatment of skin inflammatory conditions, hay fever and asthma. The industrial manufacturing routes to...
Mometasone furoate is a synthetic corticosteroid used in the treatment of skin inflammatory conditions, hay fever and asthma. The industrial manufacturing routes to mometasone furoate are generally accompanied by the formation of numerous process impurities that need to be detected and quantified, as requested by regulatory authorities. The ready availability of such impurities in the required quantity and purity is therefore essential for toxicological studies, analytical method development and process validation. Herein, we report the multi-gram scale preparation of 21'-chloro-(16'α-methyl-3',11',20'-trioxo-pregna-1',4'-dien-17'-yl)-furan-2-carboxylate (mometasone furoate EP impurity C), one of the known impurities of mometasone furoate. This study also includes the systematic investigation of the final acylation step, as well as the characterization of the difuroate enol ether intermediate and its conversion to the target impurity C.
Topics: Humans; Mometasone Furoate; Pregnadienediols; Asthma; Acylation
PubMed: 38067588
DOI: 10.3390/molecules28237859 -
Pulmonary Therapy Sep 2023GINA guidelines recommend increasing the dose of inhaled corticosteroids (ICS) as a step-up option for patients with inadequately controlled asthma at GINA step 4...
INTRODUCTION
GINA guidelines recommend increasing the dose of inhaled corticosteroids (ICS) as a step-up option for patients with inadequately controlled asthma at GINA step 4 [inadequately controlled asthma on medium-dose ICS/long-acting beta-2 agonist (LABA)]. The aim of this study was to compare the efficacy and safety of long-acting muscarinic antagonists (LAMA) add-on to medium-dose ICS/LABA in patients at GINA 2022 step 4.
METHODS
This post hoc analysis of the IRIDIUM study evaluated the change from baseline in trough forced expiratory volume (FEV ) in patients receiving medium-dose MF/IND/GLY versus high-dose MF/IND and high-dose FLU/SAL at Week 26. Other outcomes included improvement in lung functions [peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow between 25% and 75% of the FVC (FEF))], asthma control [Asthma Control Questionnaire (ACQ-7)], responder analysis (≥ 0.5 unit improvement in ACQ-7), and reduction in asthma exacerbations at Weeks 26 and 52.
RESULTS
A total of 1930 patients were included in this analysis. Medium-dose MF/IND/GLY improved trough FEV versus high-dose MF/IND (Δ 41 mL; 95% CI - 7-90) and high-dose FLU/SAL (Δ 88 mL; 95% CI 39-137) at Week 26 which were sustained until Week 52. Exacerbation rates were 16% lower with medium-dose MF/IND/GLY versus high-dose MF/IND for all (mild, moderate, and severe) exacerbations and 21-30% lower versus high-dose FLU/SAL for all (mild, moderate, and severe), moderate or severe, and severe exacerbations over 52 weeks. Further improvements in other lung functions were observed with medium-dose MF/IND/GLY. No new safety signals were identified.
CONCLUSION
Medium-dose MF/IND/GLY improved lung function and reduced asthma exacerbations compared to high-dose ICS/LABA and may be an undervalued option in patients at GINA 2022 step 4.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02571777.
PubMed: 37526856
DOI: 10.1007/s41030-023-00234-y -
Asian Pacific Journal of Allergy and... Dec 2023Intranasal corticosteroid (INCS) has a beneficial effect on ocular symptoms in allergic rhinitis (AR). To our knowledge, the cost-effectiveness of available INCS for AR... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Intranasal corticosteroid (INCS) has a beneficial effect on ocular symptoms in allergic rhinitis (AR). To our knowledge, the cost-effectiveness of available INCS for AR with ocular symptoms is yet to be demonstrated.
OBJECTIVE
To evaluate the cost-effectiveness of INCSs including Budesonide (BANS), Mometasone furoate (MFNS), Triamcinolone (TANS), and Fluticasone furoate (FFNS) on ocular symptoms associated with AR in the Thai context.
METHODS
The percentage of effectiveness in improving total ocular symptoms score (TOSS) was derived from the result of a meta-analysis that estimated the SMD of each INCS treatment compared to placebo as clinical input parameters. A cost-effectiveness analysis based on a decision-tree model to assess one-year costs and outcomes from a Thai societal perspective. The outcomes were to compare incremental cost-effectiveness ratio (ICER). Probabilistic sensitivity analyses (PSA) were also conducted to capture parameter uncertainties.
RESULTS
13 eligible RCTs with a total of 3,722 patients with SAR were included in the analysis. The percentage of effectiveness of FFNS, MFNS, TANS, and BANS was 59.89%, 45.60%, 24.89%, and 16.00%, respectively. The ICER of FFNS, MFNS, and TANS is THB-6,539.92, 4,593.83, and 1,401.24 compared to BANS. CECA result showed the probability of using FFNS is considered cost-effective in 87.50% of cases from zero value followed by MFNS (0.80%), TANS (5.40%), and BANS (6.30%). With a threshold greater than THB20,000, FFNS is considered a cost-effective strategy.
CONCLUSIONS
FFNS is a cost-effective option compared to alternative INCSs in Thailand for treating AR with ocular symptoms.
Topics: Humans; Rhinitis, Allergic, Seasonal; Cost-Effectiveness Analysis; Rhinitis, Allergic; Administration, Intranasal; Adrenal Cortex Hormones; Mometasone Furoate; Anti-Allergic Agents; Treatment Outcome
PubMed: 37874315
DOI: 10.12932/AP-070823-1669 -
Sleep Medicine Apr 2024Pediatric obstructive sleep apnea (OSA) is a common disease that can have significant negative impacts on a child's health and development. A comprehensive evaluation of... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
Pediatric obstructive sleep apnea (OSA) is a common disease that can have significant negative impacts on a child's health and development. A comprehensive evaluation of different pharmacologic interventions for the treatment of OSA in children is still lacking.
OBJECTIVE
This study aims to conduct a comprehensive systematic review and network meta-analysis of pharmacological interventions for the management of obstructive sleep apnea in pediatric population.
DATA SOURCES
PubMed, Web of Science, Embase, The Cochrane Library, and CNKI were searched from 1950 to November 2022 for pediatric OSA.
STUDY SELECTION
Multiple reviewers included Randomized controlled trials (RCTs) concerning drugs on OSA in children.
DATA EXTRACTION AND SYNTHESIS
Multiple observers followed the guidance of the PRISMA NMA statement for data extraction and evaluation. Bayesian network meta-analyses(fixed-effect model) were performed to compare the weighted mean difference (WMD), logarithmic odds ratios (log OR), and the surface under the cumulative ranking curves (SUCRA) of the included pharmacological interventions. Our protocol was registered in PROSPERO website (CRD42022377839).
MAIN OUTCOME(S) AND MEASURE(S)
The primary outcomes were improvements in the apnea/hypopnea index (AHI), while secondary outcomes included adverse events and the lowest arterial oxygen saturation (SaO2).
RESULTS
17 RCTs with a total of 1367 children with OSA aged 2-14 years that met the inclusion criteria were eventually included in our systematic review and network meta-analysis. Ten drugs were finally included in the study. The results revealed that Mometasone + Montelukast (WMD-4.74[95%CrIs -7.50 to -2.11], Budesonide (-3.45[-6.86 to -0.15], and Montelukast(-3.41[-5.45 to -1.39] exhibited significantly superior therapeutic effects compared to the placebo concerning apnea hypopnea index (AHI) value with 95%CrIs excluding no effect. Moreover, Mometasone + Montelukast achieved exceptionally high SUCRA values for both AHI (85.0 %) and SaO2 (91.0 %).
CONCLUSIONS AND RELEVANCE
The combination of mometasone furoate nasal spray and oral montelukast sodium exhibits the highest probability of being the most effective intervention. Further research is needed to investigate the long-term efficacy and safety profiles of these interventions in pediatric patients with OSA.
Topics: Child; Humans; Network Meta-Analysis; Acetates; Sleep Apnea, Obstructive; Mometasone Furoate; Cyclopropanes; Quinolines; Sulfides
PubMed: 38460418
DOI: 10.1016/j.sleep.2024.01.030 -
Cutaneous and Ocular Toxicology May 2024: This work was to explore the efficacy and safety of self-made WenyangJianpi-qushi Decoction plus mometasone furoate cream in atopic dermatitis (AD) of spleen...
Efficacy and safety of self-made WenyangJianpi-qushi Decoction combined with mometasone furoate cream in the treatment of atopic dermatitis of spleen deficiency and dampness accumulation type.
: This work was to explore the efficacy and safety of self-made WenyangJianpi-qushi Decoction plus mometasone furoate cream in atopic dermatitis (AD) of spleen deficiency and dampness accumulation type. : 120 patients with this kind of atopic dermatitis were grouped: The Observation group (disease health education + basic treatment + mometasone furoate cream + self-made Decoction) and The Control group (disease health education + basic treatment + mometasone furoate cream), 60 cases in each group. The SCORAD score, serum IgE level, peripheral blood eosinophils, adverse events, recurrence rate, and total effective rate after treatment were observed.: Through treatment, SCORAD score of the observation group (29.96 ± 2.88) was lower as against controls (36.04 ± 3.12), 0.05. Through treatment, the peripheral blood eosinophil count in the observation group was (311.26 ± 50.19) 10/L, which was lower than (582.71 ± 54.75) 10/L in controls; the serum lgE of the observation group was (712.44 ± 93.32) IU/mL, which was lower than the controls (890.12 ± 81.25) IU/mL, 0.05. The Observation group (56/60, 93.33%) demonstrated superior total effective rate to the controls (34/60, 56.67%); The recurrence rate of the observation group was 4/60 (6.67%), which was lower than the controls 16/60 (26.67%), 0.05.: Self-made WenyangJianpi-qushi Decoction plus mometasone furoate cream to treat atopic dermatitis of spleen deficiency and dampness accumulation type has significant efficacy and good safety.
PubMed: 38781033
DOI: 10.1080/15569527.2024.2354734 -
Supportive Care in Cancer : Official... Aug 2023This systematic review and meta-analysis evaluates the efficacy of Mepitel Film in preventing acute radiation dermatitis (RD) in patients with head and neck cancer (HNC)... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
This systematic review and meta-analysis evaluates the efficacy of Mepitel Film in preventing acute radiation dermatitis (RD) in patients with head and neck cancer (HNC) across randomized controlled trials (RCTs).
METHODS
Embase, MEDLINE, and Cochrane Central Register of Controlled Trials were searched on 5 March 2023 to identify relevant RCTs. RD assessment tools and outcomes were compared across studies. Pooled effect sizes and 95% confidence intervals (CI) were estimated based on random-effects analysis using RevMan 5.4.
RESULTS
Three RCTs conducted between 2018 and 2020 were included. Mepitel Film decreased RD severity when compared to Sorbolene or Biafine but not when compared to mometasone. A per-protocol analysis of two of the trials revealed that, overall, Mepitel Film significantly reduced the incidence of grade 2-3 RD (odds ratio (OR), 0.24; 95% CI, 0.09-0.65; p = 0.005) and moist desquamation (OR, 0.21; 95% CI, 0.10-0.46; p < 0.0001) and decreased average patient, researcher, and combined components of the Radiation-Induced Skin Reaction Assessment Scale (the standardized mean difference (SMD) for patient ratings, - 2.56; 95% CI, - 3.15 to - 1.96, p < 0.00001; SMD for researcher ratings, - 3.47; 95% CI, - 6.63 to - 0.31, p = 0.03; SMD for combined scores, - 3.68; 95% CI, - 6.43 to - 0.92, p = 0.009). Noted issues with Mepitel Film included itchiness and poor adherence.
CONCLUSION
While there were discrepancies across studies, Mepitel Film demonstrated a decrease in the incidence of grade 2-3 RD and moist desquamation. These findings emphasize the need for further examining Mepitel Film's efficacy across diverse patient groups and the importance of standardizing RD severity assessment methodologies and control arms.
Topics: Humans; Randomized Controlled Trials as Topic; Head and Neck Neoplasms; Motion Pictures; Dermatitis
PubMed: 37594538
DOI: 10.1007/s00520-023-07988-w -
Pulmonary Therapy Sep 2023Suboptimal adherence to inhaled asthma therapy is associated with poor clinical outcomes. Digital companion paired inhaler devices record medication use and provide...
INTRODUCTION
Suboptimal adherence to inhaled asthma therapy is associated with poor clinical outcomes. Digital companion paired inhaler devices record medication use and provide reminders, thereby improving treatment adherence and asthma outcomes. This analysis assessed the impact of indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF) Breezhaler digital companion on medication adherence and symptom control in adults with asthma from Germany.
METHODS
This retrospective analysis included adults (≥ 18 years) with asthma and prescribed Breezhaler digital companion. Assessments included: mean medication adherence (number of puffs taken/prescribed × 100) and change in Asthma Control Test (ACT) scores [well controlled (≥ 20), not well controlled (15-20) and poorly controlled (≤ 15)] at 1 month after the first ACT (second ACT). The percent of patients with ≥ 80% medication adherence (days 16-30 and 76-90) and the change in ACT (baseline and ≥ 30 days) were analysed.
RESULTS
Of the 163 patients with 90 days data, ≥ 80% medication adherence was achieved in 82.8% and 72.4% of patients at months 1 and 3, respectively. Change in asthma control was examined in ~ 60% (n = 97) of patients who completed ≥ 2 ACTs through the application. At baseline, 33.0% of patients were well controlled and 53.6% were well controlled at second ACT. Furthermore, 43.3% patients reported very poor control at baseline which decreased to 22.7% at second ACT.
CONCLUSION
The use of IND/GLY/MF (Breezhaler) with a digital companion (sensor + application) may be associated with improved symptom control and high level of controller medication adherence in patients with asthma.
PubMed: 37120785
DOI: 10.1007/s41030-023-00225-z -
Clinical Drug Investigation Sep 2023Indacaterol acetate (IND), a long-acting β-agonist in combination with mometasone furoate (MF), an inhaled corticosteroid (ICS), is being explored as a once-daily (od)... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Indacaterol acetate (IND), a long-acting β-agonist in combination with mometasone furoate (MF), an inhaled corticosteroid (ICS), is being explored as a once-daily (od) treatment for asthma in children. This study examined the efficacy, safety, and systemic exposure of IND 75 µg and IND 150 µg in children with persistent asthma.
METHODS
In this Phase IIb, multicenter, randomized, double-blind, parallel-group study, pediatric patients (aged ≥ 6 to < 12 years) with persistent asthma were randomized (1:1) to receive either IND 75 µg od or IND 150 µg od via Breezhaler in combination with ICS background therapy. The primary endpoint was change from baseline in pre-dose trough forced expiratory volume in one second (FEV) after two weeks of treatment.
RESULTS
In total, 80 patients received IND 75 µg (n = 39) or IND 150 µg (n = 41). The study met its primary endpoint; both doses demonstrated improvements in pre-dose trough FEV from baseline to Day 14 (mean change [Δ]: 212 mL, IND 75 µg; 171 mL, IND 150 µg). The secondary spirometry parameters (post-dose FEV after 1-h, post-dose forced vital capacity; morning and evening peak expiratory flow) also improved. Overall, 36.1% in IND 75 μg group and 25% patients in IND 150 μg group achieved a decrease from baseline in Pediatric Interviewer-administered Asthma Control Questionnaire score of ≥ 0.5 units. A dose-dependent increase in plasma IND concentration was noted between the two groups. Both IND doses demonstrated an acceptable safety profile.
CONCLUSIONS
Once-daily IND 75 μg and IND 150 μg via Breezhaler in combination with background ICS therapy provided substantial bronchodilation in children with asthma and were well tolerated. Taken together, these clinical and systemic exposure findings support IND 75 μg as the most appropriate dose for evaluation in Phase III trials in combination with MF in pediatric asthma.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT02892019; 08-Sep-2016).
Topics: Humans; Child; Asthma; Double-Blind Method; Forced Expiratory Volume; Acetates
PubMed: 37682405
DOI: 10.1007/s40261-023-01300-8