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BMJ Open Jan 2022This is a randomised, multi-centre, open-label, phase II study to evaluate the efficacy of betamethasone valerate ointment on radiation-induced oral mucositis in...
Preventive effects of betamethasone valerate ointment for radiation-induced severe oral mucositis in patients with oral or oropharyngeal cancer: protocol for a multicentre, phase II, randomised controlled trial (Bet-ROM study).
INTRODUCTION
This is a randomised, multi-centre, open-label, phase II study to evaluate the efficacy of betamethasone valerate ointment on radiation-induced oral mucositis in patients with head and neck cancer undergoing concomitant radiotherapy with cisplatin or cetuximab.
METHODS AND ANALYSIS
The trial will take place at seven hospitals in Japan. Patients will be randomised (1:1) into betamethasone and control groups after the occurrence of grade 1 oral mucositis. In the betamethasone group, patients will use betamethasone valerate ointment five times a day, in addition to usual oral hygiene guidance. The primary endpoint is the incidence and onset time of grade 3 oral mucositis. The secondary endpoints are the incidence and onset time of grade 2 oral mucositis, incidence and onset time of oral candidiasis, completion of radiation therapy and adverse events. Target accrual is 102 patients with a two-sided type I error rate of 5% and 80% power to detect an 80% risk reduction in the incidence of grade 3 oral mucositis.
ETHICS AND DISSEMINATION
This study was approved by the Clinical Research Review Board of Nagasaki University (No. CRB20-009). All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publication. The datasets generated during the study will be available from the corresponding author on reasonable request.
TRIAL REGISTRATION NUMBER
jRCTs071200013.
Topics: Betamethasone Valerate; Clinical Trials, Phase II as Topic; Head and Neck Neoplasms; Humans; Multicenter Studies as Topic; Ointments; Oropharyngeal Neoplasms; Radiation Injuries; Randomized Controlled Trials as Topic; Stomatitis
PubMed: 35039301
DOI: 10.1136/bmjopen-2021-056781 -
Open Access Macedonian Journal of... Nov 2019Combination of betamethasone valerate and neomycin sulfate in cream is used to treat the itching, redness, dryness, scaling, inflammation and discomfort of various skin...
BACKGROUND
Combination of betamethasone valerate and neomycin sulfate in cream is used to treat the itching, redness, dryness, scaling, inflammation and discomfort of various skin conditions caused by infection. The combination of active ingredients has side effects which can cause dry skin, thinning of the skin, hypertrichosis, and stretch marks.
AIM
The purpose of this study was to make a formula containing vitamin E and quantitative analysis of betamethasone valerate and neomycin sulfate in creams using High Performance Liquid Chromatography and Spectrophotometry Area Under Curve methods.
METHODS
Cream preparation includes smelting and emulsification processes, with oil phases namely stearic acid and vitamin E as well as water phases are glycerin, sodium bi-borate, tri-ethanolamine. Physical tests for the cream were organoleptic, homogeneity, pH, evaluation of dispersion, and viscosity. HPLC analysis for cream was carried out using C18 column, and the mobile phase of methanol: water with comparison optimization beforehand. Spectrophotometry analysis for cream was carried out using application of Area Under Curves methods.
RESULTS
The formula used was betamethasone valerate 5 mg, neomycin sulfate 25 mg, stearic acid, glycerin, sodium bi-borate, tri-ethanolamine, vitamin E and distilled water. The obtained cream was in the form of semi-solid, odorless, white (colorless), homogeneous, pH 7, the dispersion power of 500 mg cream is 4.0-4.3 cm in diameter and viscosity is 7500 Cps. Analysis of the determination of the levels of the two components was carried out by the HPLC method C-18 column with the mobile phase of methanol: water (90: 10). Betamethasone valerate and neomycin sulfate levels in formulas made HPLC methods were 94.15%, and 136.56%, respectively and using AUC spectrophotometry methods were 107.98% and 94.81%.
CONCLUSION
Cream that made by new formula with vitamin E shows good result in physical evaluation. HPLC methods with a mobile phase of methanol: water (90:10) was not recommended, while the AUC spectrophotometry method shows the valid result of quantitative analysis of betamethasone valerate and neomycin sulfate in cream.
PubMed: 32127988
DOI: 10.3889/oamjms.2019.516 -
Indian Dermatology Online Journal 2021The epidemic-like scenario of superficial fungal infections in India has been complicated by the prescription of systemic and topical potent steroids. As a result,...
BACKGROUND
The epidemic-like scenario of superficial fungal infections in India has been complicated by the prescription of systemic and topical potent steroids. As a result, alarming number of patients are presenting with exogenous Cushing's syndrome.
METHODS
This cross-sectional study involved 23 patients of superficial dermatophytosis on steroids who presented with clinical features like that of Cushing's syndrome. Their clinical details and laboratory investigations including fungal culture and serum cortisol, were recorded on a pre-designed proforma.
RESULTS
There were 23 patients (14 males and 9 females) with mean age of 29.47 ± 15.5 years, majority with extensive tinea cruris and corporis. All of them received oral (Betamethasone) or parenteral corticosteroids along with potent topical steroids (clobetasol propionate and betamethasone valerate) for at least two months. In majority (56.5%), treatment was prescribed by unqualified medical practitioners and in the rest by alternative medical practitioners. Striae, buffalo hump, hirsutism were observed in 16 (69.5%), 15 (65.2%), 13 (56.5%) patients, respectively. Serum cortisol estimation revealed low levels and ranged from 0.66 to 6 μg/ml with a mean of 1.53 ± 1.27 μg/ml (normal 7-25 μg/ml).
CONCLUSIONS
Corticosteroids are life saving for many dermatological diseases; their injudicious use (topical, oral, and parenteral) for prolonged periods in the treatment of superficial dermatophytosis can lead to Cushing's syndrome.
PubMed: 33959519
DOI: 10.4103/idoj.IDOJ_432_20 -
Archives of Dermatological Research Apr 2023Alopecia areata (AA) is a non-scarring tissue-specific autoimmune disorder. Many therapeutic modalities are available for the treatment of AA, but none has yet proven to...
Alopecia areata (AA) is a non-scarring tissue-specific autoimmune disorder. Many therapeutic modalities are available for the treatment of AA, but none has yet proven to be uniformly effective. Fractional carbon dioxide (FRCO) laser has been introduced as a treatment modality for AA. The objective is to evaluate and compare the efficacy and safety of FRCO laser in treatment of AA alone or in combination with betamethasone valerate cream. 30 patients were assigned to one of the following groups, Group A FRCO, Group B FRCO plus betamethasone valerate cream or Group C (betamethasone valerate cream). Patients received eight laser sessions 2 weeks apart, treatment period was 4 months. A statistically significant decrease in SALT score, dystrophic hair and a statistically significant increase in terminal hair was observed in all groups. Patient satisfaction level and reduction in SALT score were significantly higher among FRCO and FRCO plus betamethasone valerate group. However, no statistical significant difference was found between FRCO group and FRCO combined with betamethasone valerate cream group. FRCO laser is a safe and effective treatment modality for AA when used alone or in combination with betamethasone valerate cream. However, it was found superior to betamethasone valerate cream monotherapy.
Topics: Humans; Betamethasone Valerate; Alopecia Areata; Carbon Dioxide; Lasers, Gas; Treatment Outcome; Betamethasone
PubMed: 36114868
DOI: 10.1007/s00403-022-02393-5 -
Scientific Reports Jan 2022Glucocorticoids (GCs) are commonly used topical treatments for skin diseases but are associated with both local and systemic side effects. In this study, we describe a...
Glucocorticoids (GCs) are commonly used topical treatments for skin diseases but are associated with both local and systemic side effects. In this study, we describe a selective non-steroidal glucocorticoid receptor (GR) agonist for topical use, LEO 134310, which is rapidly deactivated in the blood resulting in low systemic exposure and a higher therapeutic index in the TPA-induced skin inflammation mouse model compared with betamethasone valerate (BMV) and clobetasol propionate (CP). Selectivity of LEO 134310 for GR was confirmed within a panel of nuclear receptors, including the mineralocorticoid receptor (MR), which has been associated with induction of skin atrophy. Topical treatment with LEO 134310 in minipigs did not result in any significant reduction in epidermal thickness in contrast to significant epidermal thinning induced by treatment with BMV and CP. Thus, the profile of LEO 134310 may potentially provide an effective and safer treatment option for skin diseases compared with currently used glucocorticoids.
Topics: Glucocorticoids
PubMed: 35087193
DOI: 10.1038/s41598-022-05471-w -
Brazilian Journal of Physical Therapy 2024Lateral elbow tendinopathy is a common musculoskeletal disorder. Effectiveness of non-invasive therapies for this health condition are unclear. (Meta-Analysis)
Meta-Analysis Review
Effectiveness of non-invasive therapies on pain, maximum grip strength, disability, and quality of life for lateral elbow tendinopathy: A systematic review and meta-analysis.
BACKGROUND
Lateral elbow tendinopathy is a common musculoskeletal disorder. Effectiveness of non-invasive therapies for this health condition are unclear.
OBJECTIVE
To investigate the effectiveness of non-invasive therapies on pain, maximum grip strength, disability, and quality of life for lateral elbow tendinopathy.
METHODS
Searches were conducted on MEDLINE, Embase, CINAHL, AMED, PEDro, Cochrane Library, SPORTDiscus and PsycINFO without language or date restrictions up to May 3rd, 2023. Randomized trials investigating the effectiveness of any non-invasive therapy compared with control or other invasive interventions were included. Two independent reviewers screened eligible trials, extracted data, and assessed the risk of bias of included trials and certainty of the evidence.
RESULTS
Twenty-two different therapies investigated in 47 randomized trials were included in the quantitative analysis. Moderate certainty evidence showed that betamethasone valerate medicated plaster may reduce disability (mean difference -6.7; 95% CI -11.4, -2.0) in the short-term when compared with placebo. Low certainty evidence showed that acupuncture may reduce disability (MD -9.1; 95% CI -11.7, -6.4) in the short-term when compared with sham. Moderate to very low certainty of evidence also showed small to no effect of non-invasive therapies on pain intensity, maximum grip strength, and disability outcomes in the short-term compared to control or invasive interventions. Most therapies had only very low certainty of evidence to support their use.
CONCLUSIONS
Decision-making processes for lateral elbow tendinopathy should be carefully evaluated, taking into consideration that most investigated interventions have very low certainty of evidence. There is an urgent call for larger high-quality trials.
Topics: Humans; Quality of Life; Hand Strength; Tendinopathy; Pain
PubMed: 38402668
DOI: 10.1016/j.bjpt.2024.100596 -
European Journal of Oral Sciences Apr 2021Oral lichen planus (OLP) is an immune-mediated disease of the oral mucosa with idiopathic aetiology. It is frequently treated with topical corticosteroids (applied as...
Oral lichen planus (OLP) is an immune-mediated disease of the oral mucosa with idiopathic aetiology. It is frequently treated with topical corticosteroids (applied as gels, mouthwashes, or sprays); however, the mucosal exposure times of topical corticosteroids are short because of removal by the constant flow of saliva and mechanical forces. In this study we used cell monolayers, as well as oral mucosal equivalents (OMEs) containing activated T-cells, to examine corticosteroid potency and delivery of clobetasol-17-propionate from a novel electrospun mucoadhesive patch. The OMEs displayed tight junctions, desmosomes, hemidesmosomes, and an efficient permeability barrier. Following application of corticosteroids to cells cultured as monolayers, the degree of cytotoxicity measured correlated to the level of potency recognized for each corticosteroid; by contrast, OMEs were largely unaffected by corticosteroid treatment. Permeation of clobetasol-17-propionate into and through the OMEs was time- and dose-dependent, regardless of whether this corticosteroid was delivered in liquid form or from a mucoadhesive patch, and both liquid- and patch-delivered clobetasol-17-propionate significantly reduced the secretion of interleukin-2 by activated T-cells. This study confirms that OMEs are more suitable models than cell monolayers for evaluating toxicity and drug delivery. After topical exposure, clobetasol-17-propionate accumulated in OMEs at a higher level than betamethasone-17-valerate and hydrocortisone-17-valerate, and exerted its immunosuppressive actions following application via the patch delivery system, highlighting the efficacy of this mode of drug delivery to treat OLP.
Topics: Administration, Topical; Adrenal Cortex Hormones; Clobetasol; Glucocorticoids; Humans; Lichen Planus, Oral; Mouth Mucosa
PubMed: 33645844
DOI: 10.1111/eos.12761 -
Drug Delivery and Translational Research Apr 2022Predicting the dermal bioavailability of topically delivered drugs is challenging. In this work, minimally invasive stratum corneum (SC) sampling was used to quantify...
Predicting the dermal bioavailability of topically delivered drugs is challenging. In this work, minimally invasive stratum corneum (SC) sampling was used to quantify the delivery of betamethasone valerate (BMV) into the viable skin. Betnovate® cream (0.1% w/w BMV) was applied at three doses (2, 5, and 10 mg cm) to the ventral forearms of 12 healthy volunteers. The mass of drug in the SC was measured using a validated tape-stripping method (a) after a 4-h "uptake" period, and (b) following a 6-h "clearance" period subsequent to cream removal. Concomitantly, the skin blanching responses to the same doses were assessed with a chromameter over 22 h post-application. BMV uptake into the SC was significantly higher for the 5 mg cm dose compared to those of 2 and 10 mg cm. In all cases, ~30% of the drug in the SC at the end of the uptake period was cleared in the subsequent 6 h. From the SC sampling data, the average drug flux into the viable epidermis and its first-order elimination rate constant from the SC were estimated as 4 ng cm h and 0.07 h, respectively. In contrast, skin blanching results were highly variable and insensitive to the dose of cream applied. The SC sampling method was able to detect a 50% difference between two applied doses with 80% power; detection of a 20% difference would require a larger sample size. SC sampling enabled quantitative metrics describing corticosteroid delivery to the viable epidermis to be determined.
Topics: Betamethasone Valerate; Epidermis; Glucocorticoids; Humans; Skin; Skin Absorption
PubMed: 34599470
DOI: 10.1007/s13346-021-01064-8 -
Journal of Clinical Medicine Sep 2023Umbilical granuloma (UG) is a common problem during the neonatal period; however, its epidemiology and etiology are poorly studied, and the best treatment option has not...
Umbilical granuloma (UG) is a common problem during the neonatal period; however, its epidemiology and etiology are poorly studied, and the best treatment option has not yet been established. We examined the medical records of neonates who were born and underwent 1-month evaluations at our hospital between 2013 and 2022 to investigate the frequency of-and factors associated with-UG, as well as the annual trends of UG treatments and their efficacy. Of the 6680 eligible neonates, 395 (5.9%) had UG. The annual incidence rate ranged from 3.8% to 7.3%. Gestational age, birth weight, and incidence of meconium-stained amniotic fluid were significantly associated with UG. Silver nitrate cauterization was the predominant UG treatment from 2013 to 2016. Silver nitrate cauterization and topical betamethasone valerate were nearly equally applied in 2017. Betamethasone application became predominant in 2018. The healing rates during the initial treatment period were 91% for silver nitrate cauterization, 97.7% for betamethasone application, 60% for ethanol disinfection, and 88% for ligation; these rates were significantly different ( < 0.001). Topical steroid application may be the most effective treatment. If steroid application is ineffective, then silver nitrate cauterization and ligation may be important treatment options.
PubMed: 37763044
DOI: 10.3390/jcm12186104 -
Indian Journal of Pharmacology 2021Nicolau syndrome is a rare serious drug reaction associated with the administering various injectable medications. It is often characterized by an acute and severe pain... (Review)
Review
Nicolau syndrome is a rare serious drug reaction associated with the administering various injectable medications. It is often characterized by an acute and severe pain accompanying erythema that tends to rapidly evolve into the livedoid reticular or hemorrhagic patches and less commonly to ulcers and skin necrosis. Herein, we report a 34-year-old woman who presented with painful, tender discoloration over her abdominal skin following subcutaneous glatiramer acetate injection. Since the patient was diagnosed with multiple sclerosis 18 months ago, she had been on treatment with subcutaneous glatiramer acetate injections thrice weekly. The patient was diagnosed with Nicolau syndrome clinically and histopathologically. After 15-day treatment with topical betamethasone valerate and mucopolysaccharide polysulfate cream twice daily, the lesion completely regressed with only minimal hypopigmented irregular scarring. Nicolau syndrome should be considered in patients with severe pain, tenderness, and redness localized at the injection site following glatiramer subacetate.
Topics: Adult; Antirheumatic Agents; Diagnosis, Differential; Female; Glatiramer Acetate; Humans; Injections, Subcutaneous; Multiple Sclerosis; Nicolau Syndrome
PubMed: 34975138
DOI: 10.4103/ijp.ijp_166_21