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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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We have introduced a reverse transcriptase polymerase chain reaction based method to measure mRNA levels of the melanogenesis enzymes tyrosinase, tyrosinase-related-protein 1 (TRP-1), and tyrosinase-related-protein 2 (TRP-2). Expression was determined by reverse transcriptase-competitive multiplex polymerase chain reaction of (i) melanogenesis enzyme transcripts and the "housekeeping" gene glyceraldehyde-3-phosphate dehydrogenase, and (ii) two internal standards consisting of mutated melanogenesis enzyme cDNA and mutated gene glyceraldehyde-3-phosphate dehydrogenase cDNA. This was investigated on in vitro cultured melanocytes in the presence of three different steroids; one glucocorticoid (betamethasone-17-valerate) and two sex steroids (diethylstilbestrol and estradiol). All three steroids lead to an increase of about 1.5-2.5-fold of tyrosinase transcripts. The amount of TRP-1 transcripts was likewise enhanced, but only moderately (approximately 1.5-fold). In contrast, TRP-2 transcripts were reduced by approximately 40% in number after betamethasone-17-valerate treatment, whereas the two sex steroids, diethylstilbestrol and estradiol, caused an upregulation of about 20-fold of the initial TRP-2 transcript level. We therefore suggest that hyperpigmentation during pregnancy or under contraceptive treatment is mediated by a direct induction of melanogenesis via sex steroids.
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Ten healthy human volunteers were exposed to a primary sensitizing dose of 1 mg dinitrochlorobenzene (DNCB) by an open topical technique within an area that had been pretreated with a potent topical glucocorticosteroid compound. Quantitative elicitation testing was performed on the opposite side by an open patch test technique two weeks after the sensitizing application. One (10%) of the ten subjects became sensitized. A matched control group of ten subjects was similarly sensitized without steroid treatment. Eight (80%) of the ten became sensitized. One month later, five of the eight test subjects in whom sensitization had been prevented were retested in an identical fashion without steroid pretreatment, to determine if any degree of tolerance had been induced. All five subjects became sensitized. Topical glucocorticosteroids inhibited the development of sensitization to topically applied DNCB. Tolerance was not induced by this single process.
Topical glucocorticoids for dermal application were introduced more than 40 years ago and revolutionised the treatment of inflammatory skin diseases. Today these drugs are frequently administered, although systemic and local adverse drug reactions, especially skin atrophy, are feared complications of their use. This literature review evaluates the present state of topical glucocorticoid therapy for inflammatory skin diseases. Several attempts have been made to increase the safety of topical glucocorticoid treatment. With respect to conventional compounds, new application schedules, as well as new vehicles, have been proposed. New derivatives have also been synthesized, forming the novel group of nonhalogenated double-ester-type glucocorticoids. Among these latter compounds, prednicarbate and 6-methyl-prednisolone aceponate have been characterised most thoroughly. According to in vivo studies, their anti-inflammatory activity is in the order of that of betamethasone valerate (a frequently used medium potency glucocorticoid, which is obtained by halogenation of the pregnane nucleus of the steroid molecule). Furthermore, these new congeners induce less skin atrophy than conventional glucocorticoids, as determined by in vivo and in vitro studies. Qualitative and quantitative assessment of the therapeutic and adverse effects of non-halogenated double-ester-type glucocorticoids suggests an increased benefit-to-risk ratio.
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Seven centres tested consecutive patients attending for investigation of suspected allergic contact dermatitis to these steroids at a range of concentrations in different vehicles.
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A single-center, 4-week, double-blind, randomized, vehicle-controlled comparison study to assess the safety and efficacy of 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone valerate in the treatment of IP.
A combination of multiple agents is often required to achieve treatment success for plaque-type psoriasis. We report a case series of 10 patients that were treated with betamethasone valerate foam (0.12%) in the morning and topical tazarotene cream (0.1%) in the evening for a total of 12 weeks or until plaques cleared. Erythema, scale, and thickness along with an aggregate severity score were determined at weeks 4, 8, and 12. One patient was lost to follow-up. Eight of the other 9 patients experienced improvement in their disease by week 12. Two patients were clear of their psoriasis at week 4 and 4 were clear at week 8. No adverse events, including irritation were reported; the use of the corticosteroid foam may protect against potential local irritation reported with tazarotene. The combination of tazarotene cream and betamethasone valerate foam is an effective combination approach to treating localized plaque-type psoriasis.
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In the treatment of psoriatic patients with psoralens plus long-wave ultraviolet radiation (PUVA), clearing of psoriatic lesions was obtained more quickly and with smaller doses of ultraviolet light when topically applied corticosteroid therapy was added. Twelve patients with symmetrical plaque-type psoriasis were given PUVA on one side of the body and PUVA plus betamethasone valerate on the other side in a paired comparison study. Ten of the patients had faster clearing of lesions on the side that was treated with PUVA and betamethasone than on the side treated with PUVA alone. The other two patients had equal clearing on both sides. All patients remained clear of lesions during maintenance with PUVA alone for at least five months after steroid therapy was discontinued. Combination therapy may save the patient time, expense, and unnecessary exposure to radiant energy.
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BMVc significantly reduced skin barrier function, integrity and cohesion, and the levels of pyrrolidone carboxylic acid (PCA) and urocanic acid (UCA) towards the subclinical barrier defect observed in patients with AD (nonlesional sites). TACo preserved skin barrier function, integrity, cohesion and PCA and UCA levels, while significantly increasing skin hydration to levels comparable with healthy skin. Both treatments reduced skin surface pH and trypsin-like protease activity, with TACo doing so to a significantly greater degree.
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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).
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Boys, 3-13 years of age, with non-retractable foreskin due to a tight ring at the tip were offered the regimen of twice-daily preputial retraction and topical application of 0.02% triamcinolone acetonide cream. The degree of preputial retractability was assessed at presentation and at 4 and 6 weeks of treatment. Success was defined as full retraction or free retraction up to agglutination of the foreskin to the glans.
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Sixteen studies met the inclusion criteria, of which 11 were randomized controlled trials. Most trials had a small sample size. In the rare studies in which variants other than generalized or classic lichen planus were included, they could not be analyzed separately. Body-of-evidence quality ranged from very low to moderate. Acitretin, sulfasalazine, and griseofulvin were associated with increased overall response rates in comparison with placebo. Narrow-band ultraviolet B radiation (NBUVB) was more effective than 6 weeks' low-dose prednisolone in achieving a complete response, and prednisolone was more effective than enoxaparin. Hydroxychloroquine was more effective than griseofulvin in achieving an overall response. Betamethasone valerate 0.1% ointment had comparable efficacy to calcipotriol ointment. Methotrexate was effective, with a nonsignificant difference in the complete response rate in comparison with oral betamethasone. In nonrandomized controlled trials, oral psoralen plus ultraviolet A photochemotherapy (PUVA) had comparable efficacy to a PUVA bath and NBUVB. Psoralen plus sunlight exposure (PUVASOL) and betamethasone dipropionate 0.05% cream were effective relative to a short course of oral metronidazole.
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We failed to find clear evidence of benefit for antimicrobial interventions for people with atopic eczema, despite their widespread use. This does not necessarily mean they do not work because the studies were small and poorly reported. Further large studies with long-term outcomes and clearly defined participants are urgently required.
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Patients (n = 231) were screened and randomized to treatment with BMV 0.1% plaster (n = 116) and BMV 0.1% cream (n = 115). Significantly more patients achieved clearing after 3 weeks' treatment with BMV plaster than with BMV cream (Cochran-Mantel-Haenszel test, p < 0.001); this difference was maintained at 5 weeks. The total plaque area decreased to a larger extent for the BMV plaster group compared with the BMV cream group (analysis of covariance [ANCOVA] model, p = 0.017 at week 5). PGA scores were significantly lower after 3 and 5 weeks' treatment with BMV plaster (ANCOVA model, all p ≤ 0.016 vs BMV cream). Both treatments reduced itching and soreness to a similar degree, and the incidences of relapse during the follow-up period were comparable between treatment groups. There were no significant differences in AEs between treatment groups.
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Long-term maintenance therapy of vulvar LS with a moisturizing cream can maintain the symptom relief induced by topical corticosteroids in women with vulvar LS while being safe and inexpensive. This treatment may also be associated with a reduction in topical corticosteroid use because more than half of the women could eliminate corticosteroids altogether.
Kojic acid in synergy with hydroquinone is a superior depigmenting agent as compared with other combinations.
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Currently, there are no analytical methods available in the literature that can simultaneously separate and quantitate residual levels of acetone, methylene chloride, n-butyl ether and dimethylsulfoxide in Betamethasone valerate active pharmaceutical ingredient (API). This paper describes the development and validation of a simple, efficient, accurate and robust static headspace gas chromatography method for the determination of high and low boiling residual solvents, namely acetone, methylene chloride, n-butyl ether and dimethylsulfoxide, in Betamethasone valerate API. This method has been demonstrated to be accurate, linear, precise, reproducible, specific and robust for its intended purpose. Quantitation limits (QL) for acetone, methylene chloride and n-butyl ether are 20 ppm (20 μg/g of API) and 50 ppm (50 μg/g of API) for dimethylsulfoxide. Several other APIs (Loratadine and a few other corticosteroid compounds) were analyzed using the conditions of this method to evaluate and assess the versatility of this method for the purpose of residual solvents analysis for a wide range of APIs. The results of this evaluation strongly indicates that this method can be readily used (as-is or with minor modifications) to determine both low and high boiling residual solvents present in a wide range of APIs.
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To accept human skin transplanted to the congenitally athymic (nude) mouse as a system to study human skin and its physiologic and pathologic states, it must be demonstrated that skin so maintained retains its function as a biologic unit. We have found that responses of grafted human skin and nude mouse skin to various agents differ. This difference in response has been utilized to assess barrier function and proliferative capacity of human skin grafts. Human skin grafts undergo a proliferative response when 10 ng of the tumor promoter, 12-O-tetradecanoyl phorbol 13-acetate (TPA) is applied. Nudes do not respond to this dose. Increasing the dose to 100 ng of TPA evokes a response in both. However, only in the human skin grafts can this response be blocked with betamethasone valerate (BV). In that human skin grafts do not take on their hosts' responsiveness, and the response of domestic pig skin to these agents before and after grafting is identical, the conclusion is reached that human skin appears to retain its inherent biologic unit function. The data also demonstrate some of the potential of this system to study kinetics of the epidermis of human skin.
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To examine whether pimecrolimus, a nonsteroidal inflammatory cytokine inhibitor recently introduced for the topical treatment of atopic dermatitis, differs from corticosteroids in effects on LCs.
In 20 healthy volunteers of both sexes the vasoconstrictive activity of diflucortolone valerate in two of its commercially available formulations (water-in-oil emulsion and pure fat base) was compared with that of four other substances: fluocinonide; betamethasone-17,21-dipropionate; hydrocortisone-17-butyrate; and clobetasol-17-propionate in corresponding galenical formulations. The visual assessment of vasoconstrictive activity after 10 hours revealed a statistically significant superiority of diflucortolone valerate in its fat base over the corresponding galenical formulations of fluocinonide, clobetasol-17-propionate, and hydrocortisone-17-butyrate. Diflucortolone valerate in a water-in-oil emulsion was statistically better after eight hours than the cream formulations of fluocinonide; clobetasol-17-propionate, and betamethasone-17,21-dipropionate.
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Efficacy end-points showed significant improvement in both groups. A decrease of 86% and 73% in clinical severity scores was obtained for pimecrolimus and betamethasone, respectively (P = 0.043). There was no significant difference between the two groups in terms of efficacy (P = 0.1). No adverse effect was found at the end of the 8-week trial in any of our patients.
Betesil® application resulted in a significant improvement in swelling/edema/inflammation score, if compared with aescin 10% cream (P < 0.01). As for facial ecchymosis and hematoma around the needle injection track, only two patients in the active treatment group displayed minimal ecchymosis and hematoma. In the control group, two patients presented minimal ecchymosis and three slight hematoma. However, using the ecchymosis/hematoma score, no significant difference between Betesil® and aescin 10% cream groups was observed. Patients' satisfaction was significantly higher among subjects receiving Betesil®, if compared to patients receiving aescin 10% cream (P < 0.01).
Topical calcipotriol is a vitamin D3 analogue which influences keratinocyte proliferation and differentiation. Its efficacy in cutaneous lichen planus has not been well evaluated.
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Skin, particularly the uppermost layer--the stratum corneum--presents a formidable, largely impassable barrier to the entry of most compounds. Recently, a novel thermolabile, low-residue foam vehicle, VersaFoam (Connetics Corp, Palo Alto, Calif), has emerged that offers a number of clinical and cosmetic advantages for the delivery of therapeutic agents through the skin. Two corticosteroids--mid-potency betamethasone valerate and ultra-high-potency clobetasol propionate--are now available in this formulation, and other products are in development to deliver clindamycin and ketoconazole in the foam vehicle. A series of in vitro studies have demonstrated that the new foam has the ability to deliver the active drug at an increased rate compared with other vehicles. These findings suggest that the new foam utilizes a nontraditional "rapid-permeation" pathway for the delivery of drugs. It is likely that components within the foam (probably the alcohols) act as penetration enhancers, and reversibly alter the barrier properties of the outer stratum corneum, thus driving the delivered drug across the skin membrane via the intracellular route. This is in contrast to traditional topical delivery vehicles, which must first rely on hydration of the intercellular spaces in the stratum corneum to achieve drug delivery. The latter mechanism reflects a hydration-dependent process, which may result in comparatively slower drug permeation.
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Retinoids and glucocorticoids are known to have a potential to modulate the expression of transforming growth factor-beta (TGF-beta). We investigated the effect of oral isotretinoin (13-cis-retinoic acid) on the expression of two distinct isoforms of TGF-beta, TGF-beta1 and TGF-beta2, in suction blister fluid and serum in acne patients. We also investigated the effect of topical glucocorticoid (betamethasone-17-valerate) and age on suction blister fluid TGF-beta1 in healthy volunteers. Six weeks of isotretinoin treatment caused a statistically significant 19% increase in suction blister fluid TGF-beta1. The suction blister fluid TGF-beta2 level remained below the sensitivity level of the immunoassay in many cases. Isotretinoin did not affect the serum TGF-beta1 or TGF-beta2 level. Betamethasone-17-valerate pretreatment for 3 days twice a day caused a statistically significant 17% decrease in suction blister fluid TGF-beta1. The active form of TGF-beta1 represented 5% of the total TGF-beta1 in suction blister fluid. Our diffusion calculations suggest that all TGF-beta1 and TGF-beta2 detected in suction blister fluid have diffused from systemic circulation. The increase in suction blister fluid TGF-beta1 after isotretinoin treatment seems to be of local origin, while the decrease in suction blister fluid TGF-beta1 after glucocorticoid pretreatment seems to be due to glucocorticoid-induced vasoconstriction resulting in decreased diffusion of TGF-beta1 from the circulation. Modulation of local interstitial fluid TGF-beta1 concentration may be one mechanism by which isotretinoin and glucocorticoids mediate their effects in skin.
In this study a combination of clinical and experimental investigations demonstrates the antiproliferative effect of the coal tar-containing preparation Berniter. From a concentration of 70 micrograms/ml onwards (= 0.35 micrograms coal tar/ml) Berniter inhibits DNA synthesis of transformed human keratinocytes in vitro. The growth inhibiting effect is reversible up to the ED50 concentration (257 micrograms Berniter/ml = 1.3 micrograms coal tar/ml). The tar-free vehicle has no identifiable effect on the proliferation of the cells at a concentration of 260 micrograms/ml. However, at higher concentrations (ED50 = 1023 micrograms/ml) the vehicle also inhibits cell growth, this inhibition being irreversible. The effect of Berniter and the tar-free vehicle on amino acid metabolism corresponds with the reduced growth rate. The ED50 concentrations (331 micrograms/ml for Berniter and 1445 micrograms/ml for the tar-free vehicle) are higher than those in the investigation of the proliferation. The clinical trial was performed in two groups of 12 and 11 patients, respectively, suffering from Psoriasis capillitii. After 3 days' topical treatment of both groups with salicylic acid for scaling, one group was treated for 4 weeks with betamethasone-17-valerate (in the following briefly called Bet-17-v), as a commercial lotion. The other group received Bet-17-v initially for 3 days and was then treated for 4 weeks with Berniter. The 4 parameters used for evaluation (erythema, scaling, infiltration and itching) showed a more significant improvement in the Berniter group than in the Bet-17-v group. Subjectively, treatment with Berniter was assessed to be preferable.(ABSTRACT TRUNCATED AT 250 WORDS)
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The number of fingertip units (FTUs) per gram and the area of coverage of an FTU of betamethasone valerate foam vehicle were determined and compared with those of cream, lotion, gel, and solution psoriasis treatments.
The stability of betamethasone-17-valerate in semi-solid bases has been investigated. Emphasis has been placed on the stability problems which could arise upon dilution of proprietary preparations by the use of model systems. Betamethasone-17-valerate has been shown to decompose to betamethasone-21-valerate and betamethasone alcohol. Quantitation of the decomposition was by direct densitometry on thin layer chromatographic plates. The decomposition was found to be an apparent first order process and to depend on the diluent used and its concentration. Attempts were also made to relate the rate of decomposition to the pH of the base used, and to stabilize the products.
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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.
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Seborrhoeic dermatitis affects a variable proportion of the general population, ranging from 3% to 10%. Malassezia yeast species (previously referred to as Pityrosporum) are thought to be the responsible organisms, and cause inflammation by still poorly defined mechanisms. Seborrhoeic dermatitis tends to relapse after treatment.
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In a double-blind controlled trial, desoxymethasone was compared with betamethasone valerate in 50 patients with bilateral acute dermatitis using a "within patient" type of comparison. The topical efficacy of desoxymethasone was somewhat greater than that of betamethasone valerate. It was well tolerated and produced no local side effects.
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At the end of the trial, the mean reduction of the PASI score from baseline was 38.39% with the coal tar group and 69.36% with the betamethasone valerate group. The mean percentage of the PASI score reduction was statistically significant in both groups but the betamethasone valerate group was significantly superior to the coal tar group. Both drugs' adverse effects were limited to mild irritation localized to the skin without systemic side effects. The Betamethasone valerate cream was safe, effective, and well-tolerated while the coal tar cream was described as messy, malodorous, and with a tendency to staining clothes.
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The aim of this study was to gain information on the effects of the crystal form of corticosteroids on the topical anti-inflammatory activity. Two different crystal forms, Form A and Form B, of the drugs of prednicarbate, hydrocortisone, betamethasone 17-valerate, prednisolone, and methyl prednisolone were prepared and their topical anti-inflammatory activities were measured using arachidonic acid induced ear edema assay in mice. Two crystal forms of the drugs showed differences in anti-inflammatory activity. Among the drugs examined, Form B of prednicarbate and betamethasone 17-valerate showed significantly more potent anti-inflammatory activities as compared to their Form A.
A survey of the prescribing pattern of topical treatment in a Family Practitioner Committee District revealed that 49.6% of topical preparations contained steroids and of these 11.2% were for diluted products. The majority (84%) of prescribed steroid dilutions on general practice prescription forms (F.P. 10's) were for Betamethasone-17-valerate and 83% required unrecommended diluent. The survey also revealed occasional prescriptions for high dilutions (e.g. 1 in 100 Betnovate) and unreported mixtures (e.g. Betnovate with Coal tar paste and antifungal proprietary creams mixed with steroid proprietaries). The examination of hospital prescriptions forms (F.P. 10 H.P.'s) was used to partially confirm the hypothesis that the practice of dilution and compounding of topical steroids is initiated in hospital and extrapolated to general practice.
Trauma is an immediate triggering factor in the development of necrobiosis lipoidica diabeticorum (NLD). NLD has previously never been documented in a tattoo site.
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To study the various clinical presentations of patients with topical corticosteroid-induced rosacea-like dermatitis (TCIRD), who had a history of prolonged and repeated use of topical steroids for reasons other than the known disease entities.
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The signs of psoriasis (plaque thickness, scaling, and erythema) were assessed before and after treatment. The investigator's and the patients' global assessments were also evaluated. The composite score improved from 7.7 +/- 2.1 to 3.0 +/- 2.2 with twice-a-day use and from 8.1 +/- 2.2 to 3.9 +/- 2.8 with once-daily use (p > 0.05 for the difference between groups).