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Journal of the European Academy of... Sep 2014A ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with... (Comparative Study)
Comparative Study Randomized Controlled Trial
Betamethasone valerate dressing is non-inferior to calcipotriol-betamethasone dipropionate ointment in the treatment of patients with mild-to-moderate chronic plaque psoriasis: results of a randomized assessor-blinded multicentre trial.
BACKGROUND
A ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP).
METHODS
This multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol-betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients' quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group.
RESULTS
Of 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a -0.288 (95% CI: -0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group.
CONCLUSIONS
BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP. Both treatments significantly improve patients' psoriasis and QoL.
Topics: Anti-Inflammatory Agents; Bandages; Betamethasone; Betamethasone Valerate; Calcitriol; Chronic Disease; Dermatologic Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Single-Blind Method
PubMed: 24256460
DOI: 10.1111/jdv.12270 -
Acta Poloniae Pharmaceutica 2015The lipophilicity (R(MW)) of betamethasone and its four related compounds: betamethasone-17,21-dipropionate, betamethasone-17-valerate, betamethasone-21-valerate and...
The lipophilicity (R(MW)) of betamethasone and its four related compounds: betamethasone-17,21-dipropionate, betamethasone-17-valerate, betamethasone-21-valerate and also betamethasone disodium phosphate was determined by reversed phase HPTLC and various mobile phase systems (methanol-water, dioxane-water and acetonitrile-water). The chromatographic lipophilicity parameters obtained for all examined compounds using abovementioned mobile phases onto three chromatographic plates (RP-2F254, RP-8F254, RP-18WF254) were compared with the theoretical partition coefficients which have been calculated by different computing programs: AlogPs, AClogP, AlogP, MlogP, KOWWIN, xlogP2, xlogP3, logP(ChemDraw) as well as with logP measured by shake-flask method. The results of this work demonstrate that regardless of applied method the greatest similarity in lipophilic properties show betamethasone-17-valerate, betamethasone-21-valerate and also betamethasone 17,21-dipropionate. The influence of solvent system as mobile phase on R(MW) values of examined compounds was observed. Among different mobile phases (organic modifier-water) proposed in this study, which allowed obtaining the reliable chromatographic lipophilicity parameters for all studied compounds is methanol-water mixture. The performance investigations showed that RP-HPTLC method has proved to be a rapid and cost effective analytical tool for describing the lipophilic properties of betamethasone and its related compounds.
Topics: Betamethasone; Chromatography, Reverse-Phase; Chromatography, Thin Layer; Solubility
PubMed: 26647623
DOI: No ID Found -
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 -
British Journal of Clinical Pharmacology Jan 1994Plasma concentrations of betamethasone were measured by r.i.a. after oral administration of 0.6 mg betamethasone and topical application of betamethasone 17-valerate in... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
Plasma concentrations of betamethasone were measured by r.i.a. after oral administration of 0.6 mg betamethasone and topical application of betamethasone 17-valerate in the same five healthy subjects. Betamethasone 17-valerate was prepared as a suspension in medical grade pressure sensitive adhesive and applied to a 100 cm2 area on the back for 28 h. Mean maximum plasma concentrations were 5.0 and 0.24 ng ml-1 and mean AUC values were 75.4 and 7.74 ng ml-1 h after oral and topical administrations, respectively. The mean plasma elimination half-life of betamethasone after the removal of topical betamethasone 17-valerate was 16.6 h which was twice that after oral administration, 8.1 h. Betamethasone 17-valerate may require application to the skin more than twice daily.
Topics: Administration, Oral; Administration, Topical; Adult; Betamethasone; Betamethasone Valerate; Female; Half-Life; Humans; Male; Radioimmunoassay
PubMed: 8148226
DOI: 10.1111/j.1365-2125.1994.tb04246.x -
Clinical Drug Investigation Apr 2017Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis.... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis. Betamethasone 17-valerate 2.25 mg (BV)-medicated plasters are recommended for treating psoriasis plaques localized in difficult-to-treat (DTT; elbow, knee, anterior face of the tibia) areas.
OBJECTIVE
The aim of this study was to compare the efficacy of Cal/BD foam with BV-medicated plaster in patients with plaque psoriasis.
METHODS
In this phase IIa, randomized, single-center, investigator-blinded, 4-week study, both Cal/BD foam and BV-medicated plaster were applied once daily to six test sites (three for each treatment). The primary efficacy endpoint was absolute change in total clinical score (TCS; sum of erythema, scaling, and infiltration); secondary endpoints were changes from baseline in each individual clinical score, ultrasonographic changes (total skin and echo-poor band thickness), and safety; and post hoc analysis was change from baseline in TCS on DTT areas.
RESULTS
Thirty-five patients were included. Least-squares mean change in TCS from baseline was significantly greater for Cal/BD foam (-5.8) than BV-medicated plaster (-3.7; difference -2.2; 95% confidence interval -2.6 to -1.8; p < 0.001); greater changes for Cal/BD foam were observed from day 8 for each clinical sign. Absolute total skin and echo-poor band thickness change was significantly greater for Cal/BD foam than for BV-medicated plaster (both p < 0.001). Post hoc analyses showed that Cal/BD foam was significantly more effective than BV-medicated plaster on DTT areas after 4 weeks (p < 0.001), and both treatments were well tolerated.
CONCLUSION
Cal/BD foam demonstrated superior efficacy versus BV-medicated plasters, including on DTT areas, in patients with plaque psoriasis.
CLINICAL TRIAL REGISTRATION NUMBER
NCT02518048.
Topics: Adult; Aerosols; Betamethasone; Betamethasone Valerate; Calcitriol; Dermatologic Agents; Female; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Single-Blind Method; Treatment Outcome
PubMed: 27995521
DOI: 10.1007/s40261-016-0489-5 -
Chemical & Pharmaceutical Bulletin 2014Laboratory tests of the decomposition of corticosteroids during activated sludge processing were investigated. Corticosteroid standards were added to activated sludge,...
Laboratory tests of the decomposition of corticosteroids during activated sludge processing were investigated. Corticosteroid standards were added to activated sludge, and aliquots were regularly taken for analysis. The corticosteroids were extracted from the samples using a solid-phase extraction method and analyzed LC-MS. Ten types of corticosteroids were measured and roughly classified into three groups: 1) prednisolone, triamcinolone, betamethasone, prednisolone acetate, and hydrocortisone acetate, which decomposed within 4 h; 2) flunisolide, betamethasone valerate, and budesonide of which more than 50% remained after 4 h, but almost all of which decomposed within 24 h; and 3) triamcinolone acetonide, and fluocinolone acetonide of which more than 50% remained after 24 h. The decomposed ratio was correlated with each corticosteroid's Log P, especially groups 2) and 3).
Topics: Adrenal Cortex Hormones; Chromatography, Liquid; Mass Spectrometry; Sewage
PubMed: 24390495
DOI: 10.1248/cpb.c13-00624 -
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 -
Acta Poloniae Pharmaceutica 2014A new simple and rapid TLC-densitometric procedure for the separation and identification of betamethasone and its related substances, betamethasone-17,21-dipropionate,...
A new simple and rapid TLC-densitometric procedure for the separation and identification of betamethasone and its related substances, betamethasone-17,21-dipropionate, betamethasone-17-valerate, betamethasone-21-valerate and also betamethasone disodium phosphate was developed. One of the chromatographic systems proposed in this study, which has been satisfactory applied in separation of four pairs of examined compounds was silica gel 60F254 (E. Merck, Art. 1.05554) and a mixture containing chloroform-methanol-acetic acid (99.5%) in volume composition 28:5:0.5. Densitometric measurements were done using densitometer TLC Scanner 3 at 246 nm. The proposed method was checked in terms of its specificity for the determination of betamethasone-17,21-dipropionate and betamethasone disodium phosphate in commercially available products containing both compounds, separately, as active ingredients. The results showed that the method is suitable for qualitative analysis of betamethasone derivatives in simple and combined pharmaceuticals in various dosage forms e.g., lotion and injection solution. It also can be applied in quality control of pharmaceutical formulations of betamethasone and its related compounds in form of salts and esters.
Topics: Betamethasone; Chromatography, Thin Layer; Densitometry; Glucocorticoids; Ointments; Reference Standards; Sensitivity and Specificity
PubMed: 25745764
DOI: No ID Found -
AAPS PharmSciTech Mar 2013The effects of solvent [acetonitrile, methanol, and acetonitrile/water mixture (20:80, v/v)], buffer concentration (phosphate buffer, pH 7.5), ionic strength and...
The effects of solvent [acetonitrile, methanol, and acetonitrile/water mixture (20:80, v/v)], buffer concentration (phosphate buffer, pH 7.5), ionic strength and commonly employed adjuvants on the photodegradation of betamethasone-17 valerate in cream and gel formulations have been studied on exposure to UV light (300-400 nm). A validated high-performance liquid chromatography method has been used to determine the parent compound and its photodegraded products. The photodegradation data in the studied solvents showed greater decomposition of the drug in solvents with a lower dielectric constant. A comparatively higher rate of photodegradation was observed in the cream formulation compared to that for the gel formulation. The kinetic treatment of the photodegradation data revealed that the degradation of the drug follows first-order kinetics and the apparent first-order rate constants for the photodegradation reactions, in the media studied, range from 1.62 to 11.30×10(-3) min(-1). The values of the rate constants decrease with increasing phosphate concentration and ionic strength which could be due to the deactivation of the excited state and radical quenching. The second-order rate constant (k') for the phosphate ion-inhibited reactions at pH 7.5 has been found to be 5.22×10(-2) M(-1) s(-1). An effective photostabilization of the drug has been achieved in cream and gel formulations with titanium dioxide (33.5-42.5%), vanillin (21.6-28.7%), and butyl hydroxytoluene (18.2-21.6%).
Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone Valerate; Dosage Forms; Kinetics; Osmolar Concentration; Photochemical Processes; Solvents
PubMed: 23250710
DOI: 10.1208/s12249-012-9902-4 -
International Braz J Urol : Official... 2011To compare the efficacy of three different formulations containing Betamethasone Valerate versus placebo in the topical treatment of phimosis. As a secondary goal, we... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To compare the efficacy of three different formulations containing Betamethasone Valerate versus placebo in the topical treatment of phimosis. As a secondary goal, we compared the outcomes after 30 and 60 days of treatment.
MATERIALS AND METHODS
Two hundred twenty boys aged 3 to 10 years old with clinical diagnosis of phimosis were enrolled. Patients were randomized to one of the following groups: Group 1: Betamethasone Valerate 0.2% plus Hyaluronidase; Group 2: Betamethasone Valerate 0.2%; Group 3: Betamethasone Valerate 0.1% or Group 4: placebo. Parents were instructed to apply the formula twice a day for 60 days and follow-up evaluations were scheduled at 30, 60 and 240 days after the first consultation. Success was defined as complete and easy foreskin retraction.
RESULTS
One hundred ninety-five patients were included at our final analysis. Group 1 (N = 54), 2 (N = 51) and 3 (N = 52) had similar success and improvement rates, all treatment groups had higher success rates than placebo (N = 38). After 60 days of treatment, total and partial response rates for Groups 1, 2 and 3 were 54.8% and 40.1%, respectively, while placebo had a success rate of 29%. Success and improvement rates were significantly better in 60 days when compared to 30 days.
CONCLUSIONS
Betamethasone Valerate 0.1%, 0.2% and 0.2% in combination with Hyaluronidase had equally higher results than placebo in the treatment of phimosis in boys from three to ten years-old. Patients initially with partial or no response can reach complete response after 60 days of treatment.
Topics: Administration, Topical; Betamethasone Valerate; Child; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Glucocorticoids; Humans; Hyaluronoglucosaminidase; Male; Phimosis; Prospective Studies; Treatment Outcome
PubMed: 21756378
DOI: 10.1590/s1677-55382011000300004