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In order to quantify the intensity of skin blanching and thus predict the bioavailability of topical corticoids, a physical device allowing the measurement of light reflected from skin without any contact between the probe and the skin was used (Leveque et al., 1984). Three series of experiments were carried out: firstly, to assess the vasoconstrictor potency of four corticoids; secondly, to show the influence of the vehicle on the bioavailability of the same drug under various galenic forms, such as fatty ointments or water in oil (W/O) and oil in water (O/W) creams; thirdly, to determine the reservoir effects, if any, of some of these formulations. The results confirm previous findings about the potency of hydrocortisone acetate, triamcinolone 17-acetonide, betamethasone 17-valerate, diflucortolone valerate and clobetasol 17-propionate.
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17,21-Bis(acetyloxy)-2-bromo-6beta,9-difluoro-11beta-hydroxypregna-1,4-diene-3,20-dione (halopredone acetate; Topicon) cream, a new synthetic corticosteroid for topical use, has been evaluated against betamethasone valerate by means of double-blind sequential study, where the patients, mainly affected with psoriasis, presented symmetrically located lesions which were treated with either the new drug or the reference cream so that each patient could serve as his own control. Activity and tolerability of the two preparations were equivalent. This equivalence is particularly significant when bearing in mind that the concentration of the active principle (0.01%) contained in the halopredone acetate cream is one of the lowest employed so far and 10 times lower than that of the reference steroid (betamethasone valerate 0.1%). A second open trial, made in 30 patients suffering from psoriasis, confirmed the positive anti-inflammatory properties which the new substance had already displayed during the previous pharmacological tests.
A 51-year-old man presented with a 12-year history of an expanding, irritable rash on his buttocks, groin and scrotum. He gradually developed erythematous, annular plaques with ridged borders and depressed centres. He also had a verruciform eruption in his perianal area. A clinical diagnosis of porokeratosis confined to the genitogluteal area was confirmed histopathologically. Oral acitretin resulted in symptomatic and cosmetic improvement. He continues to be followed up to evaluate treatment outcomes.
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In this double-blind placebo-controlled trial 20 healthy volunteers applied four different corticosteroids and the cream base formulation as placebo to the volar part of both arms once a day over a 4-week period. The epidermal thickness, the dermal thickness and the skin surface roughness were assessed using OCT, high-frequency ultrasound and profilometry.
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Lesional AD skin samples after topical treatment with either BM or pimecrolimus were subjected to gene expression profile analysis.
Isolated foreskin keratinocytes were used to investigate the influence on epidermal inflammatory processes, dermal fibroblasts of the same origin to study antiproliferative activities of glucocorticoids. Interleukins were measured by ELISA-assay, the influence on II-1 alpha-production also on mRNA-level by RNAse protection assay. Proliferation was assessed by 3H thymidine incorporation and biodegradation by HPLC/UV-absorption. Cell viability was controlled by MTT assay.
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A topical pharmaceutical cream containing the active pharmaceutical ingredients (APIs) betamethasone-17-valerate and fusidic acid has been developed for the treatment of inflammatory skin conditions and associated secondary infections. In this work, a novel stability-indicating RP-HPLC method has been developed for the simultaneous quantitation of impurities of both APIs present in this cream. The HPLC column was a 150 mm × 4.6 mm I.D. YMC-Pack Pro C18 column with 3 µm particles. The column-oven temperature was maintained at 40°C and UV detection at 235 nm was used. A gradient programme was employed at a flow rate of 0.7 mL/min. Mobile phase A comprised of a 16:21:21:42 (v/v/v/v) mixture of methanol, 10 g/L phosphoric acid, HPLC grade water and acetonitrile. Mobile phase B comprised of a 24:5:5:66 (v/v/v/v) mixture of methanol, 10 g/L phosphoric acid, HPLC grade water and acetonitrile. The method has been validated according to current International Conference on Harmonisation (ICH) guidelines and applied during formulation development and stability studies. The procedure has been shown to be stability-indicating for the topical cream.
Evaluations of the comparative efficacy and safety of a newly developed emollient ointment formulation of hydrocortisone valerate 0.2 percent were made in two double-blind, multicenter trials involving 145 patients with atopic dermatitis. Data are presented which indicate that hydrocortisone valerate 0.2 percent ointment is effective in the treatment of mild to moderate atopic dermatitis, has efficacy comparable to that of other intermediate potency corticosteroid ointments, and, moreover, that it is readily accepted by patients.
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Eleven children with severe perennial asthma and a poor clinical response to disodium cromoglycate were studied in a 4-month, double blind trial involving 1 month's treatment with placebo, disodium cromoglycate, betamethasone 17 valerate, and both drugs combined according to a predetermined random design. Each drug apparently reduced symptoms and improved daily peak flow and fortnightly spirometric measurements compared with placebo, but the improvement after betamethasone 17 valerate was greater in part because of the way this group of patients was selected. There did not appear to be any additional benefit when both drugs were used together. Betamethasone 17 valerate was not compared with beclomethasone diproprionate aerosol and there is no reason to believe it may be superior. Corticosteroid aerosols have potential hazards which may prove to equal those of long-term systemic steroids, but they offer the prospect of satisfactory control of symptoms without the risk of growth suppression in children with severe asthma. Disodium cromoglycate remains the drug of choice in severe childhood asthma and the use of corticosteroid aerosols should be confined to those children who fail to respond satisfactorily to disodium cromoglycate.
The competition of some widely employed glucocorticoids with the binding of [3H]-promegestone, a highly potent synthetic progestagen, to uterine cytosol progestin receptors of the immature rat has been studied both in in vitro and ex vivo experiments. The relative binding affinities (RBA's) to progesterone were determined in vitro: fluocinolone acetonide greater than triamcinolone acetonide greater than betamethasone 17-valerate greater than prednisolone, betamethasone, triamcinolone and cortisol. After pretreating rats in vivo with progesterone or chlormadinone acetate (subcutaneously), a dose-dependent decrease in in vitro binding of [3H]-promegestone to uterine cytosol was evident. Similar decreases were obtained after pretreatment with some of the other glucocorticoids tested. Potency ratios to progesterone, arbitrarily set at 1.0, were: fluocinolone acetonide 86.7, triamcinolone acetonide 5.6, betamethasone valerate 4.1, chlormadinone acetate 2.6. Prednisolone, betamethasone, triamcinolone and cortisol were inactive. Both the in vitro and the ex vivo results clearly indicate that glucocorticoids interact with the uterine cytosol progestin receptor system, depending on their chemical structures; this interaction may account for some of their unwanted side-effects in the endocrine system. Moreover, this experimental system may prove to be a useful tool for evaluation of the progestational activities of glucocorticoids and other steroids, using the rat as an animal model.
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Topical pimecrolimus is less effective than moderate and potent corticosteroids and 0.1% tacrolimus. The therapeutic role of topical pimecrolimus is uncertain due to the absence of key comparisons with mild corticosteroids.
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Cutaneous vasoconstriction induced by topical corticosteroids was investigated using non-invasive bioengineering techniques. Corticosteroids of different potency in alcoholic solution were applied topically, under occlusion, and cutaneous blanching was investigated using visual scoring, reflectance spectroscopy (RS) and laser-Doppler flowmetry (LDF). The RS technique allowed separation of cutaneous haemoglobin content into arterial oxygenated (OH) and venous deoxygenated haemoglobin (DOH) components. Application of alcohol decreased total haemoglobin by 10%, with a corresponding 8% increase in blood flow (BF). Clobetasol propionate was the most potent vasoconstrictor, inducing significant visible blanching and decreasing DOH (30%), OH (33%) and BF (18%) (P < 0.01). Fluocinolone acetonide, betamethasone-17-valerate and dexamethasone also caused visible blanching (P < 0.01). There was no significant decrease in BF, but reflectance spectroscopy showed a decrease in DOH (P < 0.01). Tixocortol, CMJ and hydrocortisone acetate did not produce significant blanching, although DOH was decreased compared with the alcohol control. Measured by reflectance spectroscopy, corticosteroid-induced blanching was predominantly venoconstriction and only the most potent corticosteroid caused a significant decrease in OH and blood flow. This may explain why previous attempts to improve cutaneous vasoconstriction assays using laser-Doppler flowmetry have been unsuccessful.
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The primary end point of (mean) change from baseline in skin infiltrate thickness after 3 weeks of treatment showed statistically significant improvements for all treatments: betamethasone valerate cream (-286·9 μm), the selective PDE4 inhibitors roflumilast 0·5% (-237·1 μm) and TAK-084 (0·5% cream, -153·6 μm; 5% cream, -216·7 μm) and calcipotriol 0·005% (-187·7 μm) when compared with vehicle cream control (all P < 0·001). Both the TAK-084 5% and roflumilast 0·5% formulations performed well overall compared with the potent corticosteroid, betamethasone, and were ranked better than the vitamin D analogue calcipotriol. All adverse events were mild or moderate and none was serious.
This study was carried out with the objective of comparing clinical efficacy of 10% ichthammol glycerine (IG) pack with steroid-antibiotic pack for relieving pain in cases of acute otitis externa.
To assess the effectiveness of topical application of betamethasone valerate 0.1% cream in patients with chronic chilblains.
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A randomized, double-blind, left-right comparative study was carried out to compare the value of hydrocortisone 17-butyrate with that of betamethasone 17-valerate in the treatment of eczematous skin disorders. In a series of 23 patients with such disorders, no differences between the two preparations was demonstrated with regard to effectiveness.
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In total, 241 patients with moderate to severe scalp psoriasis participated in the trial. After a 2-week run-in period, each active treatment (BVM or ST) was applied for 4 weeks, with a wash-out period between the two active treatment phases of at least 4 weeks. Efficacy was evaluated by investigators unaware of treatment sequence analysing a 'target' lesion for erythema, scaling, itching and burning using a five-point grading score. Patient treatment acceptability and assessment of the influence on Psoriasis Disability Index were evaluated using an eight-item modified Finlay-Khan questionnaire at baseline and at the end of each treatment period. Safety was evaluated by recording any adverse event occurring during the study duration. BVM was applied twice daily, and ST were applied once or twice daily, according to the approved scheduled regimens.
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The weight of an FTU of foam vehicle was 52.5 +/- 5.7 microg. There were 9 to 12 times as many FTUs in 100 g of vehicle foam as in 100 g of cream or gel and 2.3 to 2.8 times as many as in 100 g of lotion or solution. The area covered by an FTU of foam vehicle was less than the area covered by an FTU of cream or gel.
B17V is most stable when added to NS and least stable in NaHCO3 solution. FLO solution prepared with either cooled boiled water or tap water is an alternative if administered immediately. Storage at 4°C can better preserve stability of B17V, over a period of 24 hours.
In 85 patients with psoriasis vulgaris the efficacy and tolerance of domoprednate and betamethasone valerate were studied in a double-blind, randomized trial lasting 4 weeks. Complete or satisfactory remission was obtained in 36% in the domoprednate group and in 53% in the betamethasone group. This difference is not statistically significant (p greater than 0.10). 3 patients on each treatment experienced some local irritation. No laboratory abnormalities were found during the study.
The bio-availability of betamethasone-17-valerate (Betnovate ointment) in emulsifying ointment (1 in 4 dilution) was investigated in ten subjects using a single-application vasoconstrictor assay; the blanching induced was measured using a skin reflectance spectrophotometer. The vasoconstrictor activity of the diluted preparations decreased with age. There was no significant difference between the vasoconstrictor activity of freshly made Betnovate 1 in 4 in emulsifying ointment and undiluted Betnovate ointment, and between 3-4 week old diluted Betnovate and emulsifying ointment base. Blanching induced by freshly prepared 4, 8 and 16-fold dilutions was not significantly different but a large reduction in blanching occurred on diluting 32-fold with emulsifying ointment. The degradation of betamethasone -17-valerate in emulsifying ointment was quantified by high performance liquid chromatography. More than 60% of the betamethasone -17-valerate underwent degradation within 6 h. There was a simultaneous increase in the concentration of betamethasone-21-valerate which peaked within 2 days and was followed by a slow degradation (half-life 8 days) to betamethasone free alcohol.
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To assess the effect of the position of a limb (dependency) on the cutaneous vasoconstrictor (blanching) assay (VCA) using topical corticosteroid preparations.
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A prospective quasi-randomized clinical trial was completely carried out in 65 patients at Department of ENT and Head and Neck Surgery, TU Teaching Hospital, Kathmandu. Patients of less or equal to 12 years of age and both gender presenting in our outpatient department from October 2008 to December 2009 and diagnosed to have acute otitis externa was evaluated. Six patients were excluded from the study because of not meeting the inclusion criteria. Alternately IG and steroid antibiotic packing were done. For steroid antibiotic group, we use betnovate-N, a combination of betnovate sodium phosphate 0.1% and neomycin sulphate 0.5%. Before packing was carried out, pain was assessed using Wong Baker Scale. Statistical analysis was done using "Z" test of mean to compare average number of pain score and visits in two different groups.
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The most effective treatment modality was P-CS according to ultrasonographic and other findings. Although there were inverse correlations between the CSA of MN and sensory and motor MN conduction velocity, no relationship was found between symptom severity, functional status and US findings or electrophysiological studies.
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Topical pimecrolimus may maintain remissions of atopic dermatitis (AD) by inhibiting subclinical inflammation.