-
European Review For Medical and... Feb 2024Endoscopic evaluation becomes difficult when excessive secretion/hypersalivation occurs in the upper airway. Intranasal corticosteroids and antihistamines reduce...
OBJECTIVE
Endoscopic evaluation becomes difficult when excessive secretion/hypersalivation occurs in the upper airway. Intranasal corticosteroids and antihistamines reduce symptoms of rhinorrhea and nasal congestion. For this reason, in our study, we aimed to examine the effects of mometasone furoate and azelastine on both the amount of secretion and upper airway obstruction in terms of possible benefits during drug-induced sleep endoscopy (DISE).
PATIENTS AND METHODS
A total of 92 patients participated in the study [69 (75%) were males and 23 (25%) were females]. Three groups in Group 1 used intranasal mometasone furoate for 30 days, Group 2 used intranasal azelastine for 30 days, and Group 3 did not use any nasal spray for 30 days. Then, DISE was performed on all patients on the 30th day. Upper airway obstructions detected in DISE were interpreted according to the VOTE classification. Furthermore, the amount of secretion and patients' tolerance levels observed during DISE were also assessed.
RESULTS
Multilevel obstruction was detected in 94.5% of all patients participating in the study. Tolerance was poor in 18 (19.5%) of the patients participating in the study. Better DISE tolerance was determined in the female gender. DISE tolerance was also better in underweight and normal-weight patients (BMI < 25).
CONCLUSIONS
This study first investigated nasal mometasone furoate and azelastine on DISE. This study showed that prior use of nasal mometasone furoate or azelastine before DISE did not affect the amount of secretion, tolerance level, severity, and configuration of obstruction.
Topics: Male; Humans; Female; Mometasone Furoate; Nose; Endoscopy; Sleep; Phthalazines
PubMed: 38436176
DOI: 10.26355/eurrev_202402_35464 -
Alternative Therapies in Health and... Mar 2024To observe the clinical effect of mometasone furoate cream sodium Alginate Skin Repair Mask in the treatment of atopic dermatitis (AD). By assessing the combined use of...
OBJECTIVE
To observe the clinical effect of mometasone furoate cream sodium Alginate Skin Repair Mask in the treatment of atopic dermatitis (AD). By assessing the combined use of these two treatments, the study aims to address a gap in knowledge regarding the effectiveness and safety of adjuvant therapies for AD, particularly in the context of Alginate Skin Repair Mask.
METHODS
Eighty patients were enrolled, including 42 males and 38 females aged 20-47 years, with an average age of (32.52±5.57) years, from July 2021 to July 2022, and the patients were divided into a single group (n=40) and a combined group (n=40) by random number table method. The patients in the single group were treated with mometasone furoate cream alone, and the patients in the combination group were treated with Alginate Skin Repair Mask on the basis of the treatment of the patients in the single group. The outcome measurements included clinical treatment effect, condition change (SCORAD score), quality of life (DLQI score), adverse reactions and disease recurrence were compared between the two groups. Both groups received treatment for 1 month. After the treatment of the patients, they were followed up for a period of 3 months.
RESULTS
The total effective rate of the single group was 80.0% (32/40), and that of the combined group was 97.5% (39/40) (P < .05). After treatment, the skin lesion area score, skin lesion degree score, pruritus insomnia score, and SCORAD total score in the combined group were significantly lower than those in the single group (35.03±9.41 vs 44.03±12.04) (all P < .05). The DLQI score of the combined group after treatment was significantly lower than that of the single group (3.72±1.53 vs 6.98±2.16) (P < .05). The incidence of adverse reactions in the single group was 22.5% (9/40), and the disease recurrence rate was 32.5% (13/40), while the incidence of adverse reactions in the combination group was 2.5% (1/40). The disease recurrence rate was 7.5% (3/40), and the incidence of adverse reactions and disease recurrence rate in the combination group were significantly lower than those in the single group (7.314, 7.812).
CONCLUSION
Mometasone furoate cream sodium Alginate Skin Repair Mask has an ideal clinical effect in the treatment of atopic dermatitis. Compared with single mometasone furoate cream, the combination of sodium Alginate Skin Repair Mask can further improve the patient's condition, improve the quality of life of the patient, and reduce the risk of adverse reactions and disease recurrence. The higher total effective rate in the combined group indicates that the addition of Alginate Skin Repair Mask to the treatment regimen resulted in improved outcomes for patients with atopic dermatitis (AD). This translates to better control of the disease, reduction in symptoms, and overall improvement in the patient's condition. However, it is important for clinicians to be aware that the use of topical glucocorticoids like mometasone furoate cream can potentially lead to adverse reactions. Some documented adverse reactions associated with long-term use of topical glucocorticoids include acne-like eruption, telangiectasia (dilation of small blood vessels), and local skin atrophy. By addressing multiple aspects of AD management, including skin barrier repair, moisturization, and inflammation control, the combination of mometasone furoate cream and Alginate Skin Repair Mask provides a more comprehensive treatment approach. This comprehensive approach may contribute to the observed reduction in recurrence rate in the combination group compared to the single group, where only mometasone furoate cream was used.
PubMed: 38430165
DOI: No ID Found -
EClinicalMedicine Mar 2024There is no trial to assess the benefits of periodically using biologics during the pollen season in patients with uncontrolled seasonal allergic rhinitis (SAR), who...
Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial.
BACKGROUND
There is no trial to assess the benefits of periodically using biologics during the pollen season in patients with uncontrolled seasonal allergic rhinitis (SAR), who have moderate-to-severe symptoms even after standard-of-care. This trial aimed to evaluate the efficacy and safety of the add-on administration of stapokibart, a humanised monoclonal antibody that targets interleukin-4 receptor alpha, in patients with uncontrolled SAR.
METHODS
In this investigator-initiated, randomised, double-blind, placebo-controlled trial, eligible patients received either stapokibart 600-300 mg weekly (QW), every 2 weeks (Q2W), or placebo QW for 4 weeks. All patients were given mometasone furoate nasal spray and loratadine throughout the trial. The primary endpoint was the mean change from baseline in daily reflective total nasal symptom score (rTNSS) during 2-week treatment. Secondary efficacy outcomes included: the mean change from baseline in daily rTNSS during 4-week treatment; the mean changes and the mean percentage changes from baseline during 2-week and 4-week treatment in 1) daily rTNSS and reflective total ocular symptom score (rTOSS), 2) morning (AM)/evening (PM) rTNSS and rTOSS, 3) AM instantaneous total nasal symptom score (iTNSS) and instantaneous total ocular symptom score (iTOSS), 4) individual nasal and ocular symptoms; the change from baseline in Rhinoconjunctivitis Quality of-Life Questionnaire score during 4-week treatment. Exploratory endpoints included the change of prespecified markers related to type 2 inflammation pre- and post-treatment. Safety, immunogenicity, and pharmacokinetics were also evaluated. This study is registered with www.clinicaltrials.gov (NCT05470647).
FINDINGS
Between August 17, 2022, and December 28, 2022, 92 patients with uncontrolled SAR were enrolled from 4 centres in China and randomly assigned to receive stapokibart 600-300 mg QW (n = 31), stapokibart 600-300 mg Q2W (n = 30), or placebo QW (n = 31), of whom 86 (93%) completed the study. Both stapokibart Q2W and QW did not significantly improve mean change from baseline in daily rTNSS compared with placebo in 2 weeks. The least-squares (LS) mean differences (97.5% confidence interval [CI]) compared with placebo were -1.0 (-2.3, 0.2) in stapokibart Q2W group (p = 0.065) and -0.2 (-1.5, 1.0) in stapokibart QW group (p = 0.67). For the secondary outcomes, compared with placebo, stapokibart Q2W presented significant improvements in the mean percentage change from baseline in daily rTNSS in 2 weeks (LS mean difference -12.9%, 95% CI -25.3%, -0.4%, p = 0.043), as well as AM iTNSS over 2 weeks (LS mean difference -17.4%, 95% CI -31.0%, -3.8%, p = 0.013) and 4 weeks (LS mean difference -15.4%, 95% CI -29.0%, -1.9%, p = 0.026). Additionally, the nasal congestion score was significantly lower in stapokibart Q2W than placebo during 2-week (LS mean difference -0.4, 95% CI -0.7, -0.1, p = 0.014) and 4-week (LS mean difference -0.4, 95% CI -0.7, -0.04, p = 0.028) treatment. Treatment-emergent adverse events (TEAEs) occurred in 48% (15/31), 33% (10/30), and 61% (19/31) of patients receiving stapokibart QW, Q2W, and placebo, respectively. Most reported TEAEs were sinus bradycardia, hyperlipidaemia, and blood uric acid increased.
INTERPRETATION
In this phase 2 trial, both stapokibart regimens had an acceptable safety and tolerability profile but did not significantly improve daily rTNSS in patients with uncontrolled SAR. The efficacy of stapokibart in patients with uncontrolled SAR is being further investigated in ongoing phase 3 trials (clinicaltrials.gov, NCT05908032).
FUNDING
Ministry of Science and Technology of the People's Republic of China; Ministry of Education of the People's Republic of China; National Natural Science Foundation of China; Chinese Academy of Medical Sciences.
PubMed: 38356731
DOI: 10.1016/j.eclinm.2024.102467 -
Dermatology Reports Dec 2023Acrodermatitis dysmetabolica (AD) describes eruptions characterized by the clinical triad of acral dermatitis, diarrhea, and alopecia. AD can be caused by various...
Acrodermatitis dysmetabolica (AD) describes eruptions characterized by the clinical triad of acral dermatitis, diarrhea, and alopecia. AD can be caused by various metabolic disorders, one of which is maple syrup urine disease (MSUD). We present a 2- month-old boy diagnosed with MSUD by the age of 5 days and treated with branched-chain amino acid (BCAA) restricted diet, BCAAs formula, and thiamine supplementation. He was referred to dermatology with a 3-week history of diarrhea, progressive acrodermatitis enteropathica like cutaneous eruption and hair loss over the scalp treated with topical mometasone ointment, isoleucine supplementation and leucine restriction. Complete resolution of skin eruption was achieved by 4 weeks, which correlates with normalization of BCAA levels based on close monitoring of biochemical lab values and growth. This case emphasizes the dangers of limiting BCAA intake when treating MSUD, as well as the importance of close monitoring during the amino acid depleting period of growth.
PubMed: 38327590
DOI: 10.4081/dr.2023.9750 -
Acta Pharmaceutica Sinica. B Jan 2024Nasal drug delivery efficiency is highly dependent on the position in which the drug is deposited in the nasal cavity. However, no reliable method is currently available...
Nasal drug delivery efficiency is highly dependent on the position in which the drug is deposited in the nasal cavity. However, no reliable method is currently available to assess its impact on delivery performance. In this study, a biomimetic nasal model based on three-dimensional (3D) reconstruction and three-dimensional printing (3DP) technology was developed for visualizing the deposition of drug powders in the nasal cavity. The results showed significant differences in cavity area and volume and powder distribution in the anterior part of the biomimetic nasal model of Chinese males and females. The nasal cavity model was modified with dimethicone and validated to be suitable for the deposition test. The experimental device produced the most satisfactory results with five spray times. Furthermore, particle sizes and spray angles were found to significantly affect the experimental device's performance and alter drug distribution, respectively. Additionally, mometasone furoate (MF) nasal spray (NS) distribution patterns were investigated in a goat nasal cavity model and three male goat noses, confirming the and correlation. In conclusion, the developed human nasal structure biomimetic device has the potential to be a valuable tool for assessing nasal drug delivery system deposition and distribution.
PubMed: 38261815
DOI: 10.1016/j.apsb.2023.06.007 -
International Journal of Women's Health 2024Vulvar intraepithelial neoplasia (VIN), the precursor lesion of vulvar squamous cell carcinoma (VSCC), may present as pruritic or asymptomatic lichenified plaques...
The Importance of p16 and p53 Immunohistochemical Staining in Diagnosing Vulvar Lichen Simplex Chronicus Mimicking Vulvar Intraepithelial Neoplasia with False-Positive Human Papillomavirus Type 66.
Vulvar intraepithelial neoplasia (VIN), the precursor lesion of vulvar squamous cell carcinoma (VSCC), may present as pruritic or asymptomatic lichenified plaques surrounded by single or multiple discrete or confluent macules or papules. VIN is divided into high-grade squamous intraepithelial lesion (HSIL), which is human papillomavirus (HPV)-driven, and differentiated VIN (DVIN), which develops independently of HPV. Histopathological examination and HPV genotyping polymerase chain reaction (PCR) tests should be performed to distinguish between HSIL and DVIN. Lichenified plaques surrounded by multiple papules are found not only in VIN but also in vulvar lichen simplex chronicus (LSC). This chronic inflammatory skin disease mostly appears in labia majora and is triggered by sweating, rubbing, and mental stress. IHC staining of p16 and p53 are recommended as the most commonly used biomarkers for VIN in diagnostically challenging cases. IHC staining is also beneficial to confirm the accuracy of the HPV detection technique, as p16-negative staining may also represent a false-positive result. We report a case of the importance of p16 and p53 IHC staining in diagnosing vulvar LSC mimicking VIN with false-positive HPV-66. The patient was previously diagnosed with VIN based on clinical examination. HPV-66 was detected by PCR from a vulvar biopsy sample. Histopathological examination revealed stromal lymphocytic infiltration with non-specific chronic dermatitis; neither atypia nor koilocyte was observed. Both p16 and p53 IHC staining were negative. The patient was diagnosed and treated as vulvar LSC with 10 mg cetirizine tablet, emollient, and 0.1% mometasone furoate cream. Clinical improvement was observed as the lesions became asymptomatic hyperpigmented macules in the 4 weeks of follow-up, without recurrence after 3 years of follow-up. Both p16 and p53 IHC staining might help distinguish HSIL and DVIN mutually and from other vulvar mimics in diagnostically challenging cases.
PubMed: 38196407
DOI: 10.2147/IJWH.S439825 -
Archives of Dermatological Research Jan 2024A myriad of therapeutic modalities for alopecia areata are available; however, none is of high level of evidence, creating an immense need for the evaluation of other... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
A myriad of therapeutic modalities for alopecia areata are available; however, none is of high level of evidence, creating an immense need for the evaluation of other treatment modalities, of which topical sodium valproate is of potential role via proposed decrease in beta-catenin breakdown, despite its well-known side effect of hair fall as an oral therapy.
OBJECTIVE
Evaluating the efficacy and the safety of sodium valproate (SV)-loaded nanospanlastics, in comparison to topical corticosteroids, this is the currently available gold standard topical treatment for patchy AA.
METHODOLOGY
A total of 66 patients with patchy AA were randomly assigned to receive either topical mometasone furoate lotion or topical SV applied twice daily to all patches except a control patch, which was left untreated. Clinical, trichoscopic and biochemical assessments of beta-catenin tissue levels and Axin-2 gene expression were carried out at baseline and after 3 months.
RESULTS
Both therapeutic modalities were comparable. Potential efficacy was highlighted by significant improvement in the representative patch, the largest treated patch, to the control patch, the smallest untreated patch in both steroid and valproate groups (p = 0.027, 0.003 respectively). Both beta-catenin levels and Axin-2 gene expression were reduced after treatment, pointing to the inhibitory effect of dominating uncontrolled inflammatory milieu. Baseline beta-catenin was found to significantly negatively correlate with improvement in the representative patch in patients with baseline level above 0.42 ng/ml (p = - 0.042).
CONCLUSION
Both topical SV and steroids are of comparable modest efficacy. Thus, further evaluation of SV is due in combination with intralesional steroids and other anti-inflammatory treatment modalities, together with developing individualized approaches based on baseline beta-catenin level.
GOV IDENTIFIER
NCT05017454, https://clinicaltrials.gov/ct2/show/NCT05017454 .
Topics: Humans; Alopecia Areata; Valproic Acid; beta Catenin; Axin Protein; Treatment Outcome
PubMed: 38170256
DOI: 10.1007/s00403-023-02785-1 -
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