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Comparison of a modified hydrocortisone/urea cream and betamethasone valerate cream in the treatment of dry eczema.

A half-sided, single-blind, comparative study of a new modified formulation of 1% hydrocortisone/10% urea and 0.1% betamethasone valerate cream in the treatment of dry eczema showed that the two products were equally effective at the end of 1, 2 and 3 weeks of treatment in terms of efficacy and speed of action. No statistically significant differences could be detected between either preparation in any of the trial's measures (i.e. overall severity score, dryness/scaling, erythema, papules, itching, excoriation or lichenification) at any of the weekly assessments. The incidence of side-effects was the same with both treatments and patients' preference was equally divided between the two creams.

Administration, Topical↗

Betamethasone valerate inhalation and exercise-induced asthma in adults.

The effect of regular inhalation of betamethasone valerate (800 microgram daily) on exercise-induced asthma has been studied in 18 adult patients. The active aerosol was compared with placebo in a double-blind cross-over study, each inhaler being used for four weeks. Exercise tests after each period of treatment were performed using a cycle ergometer, care being taken to match the oxygen uptake during exercise each time a patient was tested. Twelve patients experienced less exercise-induced fall in peak expiratory flow rate after the corticosteroid inhaler, while six did not. This effect appeared to be independent of any alteration in base-line lung function, suggesting that it was due primarily to diminution of bronchial hyperreactivity. It is suggested that this change may have been due to interference with the synthesis or release of mediator substances from mast cells.

Adolescent↗

Domoprednate (Stermonid), a topical D-homocorticosteroid, skin atrophy and telangiectasia. A double-blind, randomized comparison with hydrocortisone butyrate, betamethasone valerate, clobetasole propionate and placebo.

Five corticosteroid ointments and placebo were compared in 17 volunteers with regard to their influence on normal skin under occlusive conditions. Each volunteer had six simultaneous applications on the forearms and six on the back. The trial was double-blind and lasted 4 weeks. The ointments were placed in randomized order. The treatments were 0.1 and 0.03% domoprednate, 0.1% hydrocortisone butyrate, 0.1% betamethasone valerate, 0.05% clobetasole propionate and placebo. Skin thickness was measured on days 0, 7, 14, 21 and 28, transepidermal water loss on days 0, 14 and 28, while blood flow and telangiectasias were evaluated only on day 28 at termination of the trial. The skin thickness became significantly reduced on all corticosteroids, but not on placebo; 0.03% domoprednate, however, tended to have an intermediate position between placebo and the other ointments. The transepidermal water loss did not change. Rating of telangiectasia under stereomicroscope showed a significantly lower score after 0.03% domoprednate and placebo as compared to the other ointments. Assessment of telangiectasia by laser-Doppler flowmetry showed a similar tendency. It is concluded that 0.1% domoprednate is comparable to other topical corticosteroids with respect to atrophogeneity and formation of telangiectasia, but the 0.03% concentration seems to result in fewer side effects.

Administration, Topical↗

Effect of betamethasone valerate on the normal human facial skin flora.

Eighteen volunteers were randomly divided into two groups and allocated either an active corticosteroid preparation (Betamethasone valerate) or the basal formulation only (placebo). The cream was applied to the face twice daily for one month. The treated area was sampled by the scrub-wash method immediately before treatment began and after 2 and 4 weeks, and microorganisms were enumerated and identified. Application of either cream produced a very slight increase (less than or equal to 0.5 log cycle) in the skin flora during the first 2 weeks of treatment. There were no significant differences in the changes occurring between volunteers treated with placebo and those on the steroid formulation. The results are discussed in relation to theories of pathogenesis of perioral dermatitis and steroid acne.

Betamethasone↗

Multicenter trial analysis. Fluocinonide and betamethasone gel in psoriasis.

The relative efficacy of fluocinonide and betamethasone benzoate gels in treating the symptoms of psoriasis was evaluated in 335 patients, of whom 263 were analyzable. By means of a paired comparison design in which both drugs were examined simultaneously in the same patient, many potential sources of variation were eliminated. In addition, the analysis took into account the difficulties of pooling results in a multicenter trial. Imposing a rigorous grouping structure on the results from individual clinics minimized differences between clinics and demonstrated consistently high, statistically significant results in favor of fluocinodine gel even when several different statistical approaches were used. Local adverse reactions related to drugs were experienced by few patients.

Administration, Topical↗

Biodegradable scleral implant for controlled intraocular delivery of betamethasone phosphate.

We evaluated nail-like, biodegradable scleral implants as a controlled intraocular delivery system of betamethasone phosphate (BP) for the treatment of chronic uveitis using pigmented rabbits. The scleral implants, which contained 10% and 25% of BP (weight 8.5 mg; length 5 mm), were made of poly (D,L-lactide-co-glycolide) (PLGA). In vivo release and retinal toxicity after implantation were also studied in pigmented rabbits. The in vitro release studies demonstrated the 10% and 25% BP-loaded scleral implants released BP in a biphasic release pattern for at least 1 month. The BP concentrations in the vitreous and the retina/choroid after application of scleral implants in pigmented rabbit eyes stayed within the concentration range capable of suppressing inflammatory responses for over 1 month. The BP concentration was greater in the retina/choroid than in the vitreous throughout the study. No substantial toxic reactions in the retina were observed by electroretinography. Our findings suggest that the BP-loaded scleral implant may be a promising device for treatment of chronic uveitis.

Animals↗

Liquid chromatography mass spectrometry of dexamethasone and betamethasone.

Chemical ionization mass spectra of dexamethasone and betamethasone have been obtained via liquid chromatography mass spectrometry using a moving belt interface. These results have confirmed a concentration-dependent competition between thermal degradation and vaporization. Caution should be exercised when dealing with molecules subject to thermal instability since sample introduction via the mechanical transport system does not guarantee evaporation without thermal decomposition.

Betamethasone↗

Determination of betamethasone 17-benzoate in lipophylic vehicles by reversed-phase high-performance liquid chromatography.

A stability-indicating, reversed-phase HPLC method was developed to assay betamethasone 17-benzoate in lipophylic bases. An on-line precolumn sample clean-up system was used to protect the analytical column from contamination; it consisted of the Waters Guard-Pak Precolumn Module and the muBondapak C18 Precolumn Insert. The method is simple, specific, accurate, and precise. It is also cost effective because it extends the life of the HPLC column.

Betamethasone↗

Significance of viable skin layers in percutaneous permeation and its implication in mathematical models: theoretical consideration based on parameters for betamethasone 17-valerate.

The role of viable skin layers (viable epidermis and dermis) is examined by the three-layer model using parameter values for betamethasone 17-valerate. The mathematical three-layer diffusion model indicates that the lag time and half-life after vehicle removal in epidermis and split-thickness skin are longer than those in stratum corneum without viable layers, even if drug flux at steady-state is minimally altered. The theoretical values of the lag time and half-life predicted for epidermis and split-thickness-skin samples are compatible with the values observed in another in vitro study. The results predicted by the three-layer model indicate that the simplified model (single-layer or compartment model), which regards the whole skin as one diffusion layer or one compartment, may be warranted because all three skin layers have the same half-life after vehicle removal. The parameters used in the simplified model are estimated from some of the following values directly obtainable in the experiment: flux from skin and amount in the whole skin at steady-state, lag time, and drug concentration or amount maintained to be unchanged in the donor site. However, the simplified model often cannot resolve some discrepancy between the data and model (e.g., the ratio of the half-life to lag time) even if the data may be explained by the three-layer model.

Betamethasone Valerate↗

Resolution, quantification and confirmation of betamethasone and dexamethasone in equine plasma by liquid chromatography/tandem mass spectrometry.

This method describes the simultaneous separation, identification, quantification and confirmation of betamethasone (BTM) and dexamethasone (DXM) in equine plasma by liquid chromatography (LC) integrated with multidimensional tandem mass spectrometry. Analytes were directly extracted from equine plasma by methyl tert-butyl ether (MTBE). The residues were reconstituted with sample solvent. LC separation of the analytes was performed on a Hypercarb column using acetonitrile/water/formic acid (95:5:0.5, v/v/v) as the mobile phase. Sample screening, quantification and confirmation were performed in multiple reaction monitoring (MRM) mode. The method was linear over the concentration range of 0.1-75 ng/mL for both analytes. Limit of detection (LOD) was 50 pg/mL and that of quantification (LOQ) was 100 pg/mL for both analytes. The limit of confirmation (LOC) for the presence of BTM or DXM by MRM was 0.5 ng/mL. The intra-and inter-day precisions expressed as coefficient of variation (CV) for quantification of DXM and BTM from 0.1 to 50 ng/mL were less than 7% and the accuracy was in the range of 97-105%. This method is capable of distinguishing BTM from DXM when both analytes are simultaneously present in equine plasma. Measurement uncertainty for both analytes was estimated at less than 16%. The method is rapid, specific, selective, sensitive, simple and reliable. The importance of this method is its usefulness in directly identifying and differentiating BTM from DXM without derivatization.

Animals↗

A high-performance liquid chromatography/tandem mass spectrometric screening method for eight synthetic corticosteroids in bovine feces and the simultaneous differentiation between dexamethasone and betamethasone.

A screening method was developed to monitor the illegal use of synthetic corticosteroids in cattle. Diethyl ether extracts from spiked feces samples were cleaned-up by solid phase extraction followed by semipreparative reversed-phase chromatography (RPC). The fraction containing the corticosteroids was derivatized with ethoxyamine hydrochloride. The corresponding ethoximes were separated using silica-based C18 RPC and analyzed on-line in an ion trap mass spectrometer using atmospheric pressure positive chemical ionization. Ethoxime derivatives of dexamethasone and betamethasone were baseline resolved, allowing for the simultaneous mass spectrometric differentiation of both epimers in bovine feces by conventional non-chiral chromatography. At the lowest level tested (1 micro g/kg), corticosteroids (except triamcinolone) could be identified in compliance with the recent European criteria for residue identification. The quantitative performance of the method was best at residue levels > or = 2 micro g/kg.

Animals↗

Plasma steroid levels and clinical effects after topical application of betamethasone.

A study was made of 41 patients (45 eyes) with post-operative irritative conditions to evaluate the clinical efficacy of topical betamethasone (BM) at various concentrations. The results obtained were as follows. First, serum concentrations of BM after treatment with 0.01% and 0.05% BM solution were much lower than those found after a 0.1% solution had been applied. However, no reduction in the serum cortisol was observed in the former. Second, the clinical evaluation was made in patients after cataract extraction. Marked and moderate improvement of post-operative inflammatory changes was observed in 90% of the patients treated with 0.05% and 0.1% solution and in only 30% of those treated with 0.01% solution. This study clearly shows the efficiency of 0.05% solution of BM with minimal suppressive effects on adrenal function.

Adult↗

Infantile periocular haemangioma treated with two days in a week betamethasone oral mini pulse therapy.

A one-month-old male infant had a large asymptomatic, bright red swelling on the face with inability to open his right eye since birth. On cutaneous examination there was a large brightly erythematous, lobulated, soft plaque on the right side of the forehead of 12 cm x 10 cm, involving the right upper eyelid obscuring the visual axis and extending on to the right upper lip. Ocular examination revealed normal anterior and posterior segments. Computed tomography of head and orbit confirmed the diagnosis of capillary haemangioma. The child was treated with oral betamethasone 2 mg as the signal daily dose on the two consecutive days in a week. After six weeks there was 80% reduction in the size of the lesion and the right upper eyelid almost completely cleared the visual axis. In another six weeks, the improvement was more than 90%.

Administration, Oral↗

Betamethasone in plus phenobarbitone prior to hepatobiliary scintigraphy increases diagnostic accuracy in infants with jaundice.

OBJECTIVE: In the diagnostic work up of the child with neonatal obstructive cholangiopathy (NOC), hepatobiliary scintigraphy (HBS) determines the need for peroperative cholangiography (POC). Traditionally, phenobarbitone is recommended to prime the liver to HBS. This retrospective study was designed to evaluate whether addition of the betamethasone (BM) alters the diagnostic accuracy of the HBS in distinguishing neonatal hepatitis (NH) from extra hepatic biliary atresia (EHBA). METHODS: Between 1993-1999, 202 patients presented with NOC and this study was not designed as a prospective randomized clinical trial. Of these, 126 patients had received Phenobarbitone (Group I) and the remaining 76 (Group II) had received BM in addition to the PB in a dose of 5 mg/k/d and 2.2 mg/k/d respectively for 7 days prior to HBS. RESULTS: Retrospective analysis revealed that, in the Group I, 41 showed excretion and 85 did not show any excretion of the radiopharmaceutical and the latter underwent POC which revealed that 31 patients (36%) of them showed patent biliary tract. In group II, 32 patients revealed excretion and 44 did not show any excretion of the radiopharmaceutical and the latter had undergone POC, which revealed that only 8 patients (18%) showed patent biliary tract. The percentages of false positives (36% vs 18%) was statistically significant (p < 0.03). CONCLUSION: Addition of BM increases the diagnostic accuracy of the HBS and this would lead to decreased need for POC to distinguish NH from EHBA.

Betamethasone↗

Bullous mastocytosis treated with oral betamethasone therapy.

Bullous mastocytosis is a very rare variant of cutaneous mastocytosis. The condition is characterized by a diffuse infiltration of the skin by mast cells manifesting as yellowish, thickened doughy skin with appearance of large blisters. The authors report herewith a 7-month-old female infant with history of recurrent episodes of vesiculobullous lesions on the face, trunk and the extremities and excessive tendency to rub and scratch the skin for 3 months. She also had recurrent episodes of facial flushing. On cutaneous examination there were multiple flaccid bullae, urticarial wheals and crusted erosions on her scalp, face, neck, trunk and extremities. She had generalised yellowish thick and rough skin, giving doughy feel and 'peau d' orange' appearance of the skin at places. Systemic examination was within normal limits. Skin biopsy from a lesion showed subepidermal bulla and an upper dermal inflammatory infiltrate comprising of lymphocytes and many mast cells. Toluidine blue staining of the cells showed presence of metachromatic granules in these cells. A diagnosis of bullous mastocytosis was made and the patient was treated with oral antihistamines to which there was no satisfactory response. Betamethasone in a dose of 0.1 mg/kg/day given orally caused complete remission of the disease in 4 weeks. The drug was gradually tapered and stopped over the next 6 weeks. There were no side effects of the therapy.

Administration, Oral↗