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Background Tinea capitis is a common fungal infection in Israel, most commonly caused by the dermatophyte Trichophyton tonsurans. Objectives To investigate the effectiveness of oral antifungal monotherapy in producing clinical or complete cure. We also evaluated the impact of topical therapy (bifonazole 1% shampoo and/or betamethasone valerate 0.1% solution), prior to oral treatment, on patients' likelihood of clinical or complete cure. Methods A retrospective chart review was conducted. Patients with mycologically confirmed tinea capitis were treated with one of four regimens: (1) terbinafine (greater than 40 kg: 250 mg/day, 20 to 40 kg: 125 mg/day, less than 20 kg: 62.5 mg/day), (2) itraconazole 5 mg/kg daily, (3) fluconazole 6 mg/kg daily, or (4) griseofulvin 20 mg/kg daily. We used generalized linear models (GLM) to determine whether there was a significant association between the odds of cure and choice of treatment. Results The causative species was Trichophyton tonsurans in all but 6 cases that grew T violaceum. For pediatric patients, the odds of having complete or clinical cure within 6 weeks was greater if they used terbinafine compared to itraconazole, fluconazole, or griseofulvin (odds ratio [OR] = 9.06, P = .047). The likelihood of complete or clinical cure within 8 weeks of oral therapy was lower if topical steroids were previously used compared to if topical antifungals were used prior to systemic treatment (OR = 0.29, P = .046). Conclusions Our findings substantiate prior literature demonstrating that terbinafine is non-inferior to griseofulvin, itraconazole, and fluconazole in the therapy of pediatric tinea capitis caused by T tonsurans. more...

Topical corticosteroid therapies are widely utilized, despite the controversial results of corticoid therapy in irritant contact dermatitis as a local inflammatory reaction after repeated or single skin exposure to a chemical substance. Although corticoids may reduce the inflammatory response to the irritant, their antiproliferative effects may reduce skin barrier recovery while allowing further penetration of irritants if exposure continues. This overview reexamines the efficacy of corticosteroids in irritant contact dermatitis therapy, and with the minimal controlled experimental data currently available, notes the need for same-in this common clinical entity. more...

Introduction: Lichen planus is a relatively common chronic inflammatory disease. The bullous erosive type is characterized by the high risk of developing squamous cell carcinoma. AGEs are believed to generate chronic inflammation.Methodology: The study was carried on thirty participants; they were divided into two groups. Group (1): included 15 healthy participants free of any systemic diseases. Group (2): included 15 patients of bullous erosive oral lichen planus and free of any other diseases. Serum and salivary samples were taken from all participants at initial visit and after complete resolution of the lesions in the OLP patients using topical application of 0.1% or 0.05% betamethasone valerate gel. Results: In serum, whether before or after treatment, OLP group showed statistical significantly higher mean AGE levels than the control group. In saliva, before treatment, OLP group showed statistical significantly higher mean AGE levels than the control group. After treatment, there was a statistically significant decrease in AGE level. Conclusion: Both salivary and serum levels of AGE are valuable biomarkers in diagnosis and prognosis of OLP. Detection of AGE level in saliva can be considered as a valuable non-invasive method for diagnosis and prognosis of OLP. more...

1. Talia Greenspoon, MD, FRCPC* 2. Miriam Weinstein, MD, FRCPC* 1. *Department of Pediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada An otherwise healthy 2-year-old girl is referred to our clinic for assessment of a lesion on the right lower leg. After a trip to Mexico 15 months prior, the parents first noticed what they describe as a “tan” on the posterior aspect of her right lower leg, followed by a scaly round plaque that would come and go. There has been no pain or pruritus. She was prescribed mometasone furoate ointment, which had some benefit. She later developed red-to-purple nodules in the same area. The patient was seen by multiple providers and was prescribed a combined fusidic acid (antibiotic) and hydrocortisone 1% ointment, a 1-week course of oral cephalexin, and betamethasone valerate 0.05% ointment; each without any improvement. The patient lives in a house in an urban area. She has not had contact with any animals. There are no noted exposures to insect bites or changes in clothing or detergents. The family history is noncontributory. On physical examination, the patient appears healthy. On the right leg, there are multiple violaceous coalescent plaques with overlying erythematous papules with scale (Fig 1) with no drainage or edema. The skin is otherwise smooth and clear. There are small, mobile lymph nodes palpable in the right inguinal canal. Findings on the rest of the physical examination are normal, including range of motion of the ankles, knees, and hips … more...

There is a dearth of robust evidence regarding coronavirus disease 2019 (COVID-19)-related coetaneous manifestations, complications and adverse treatment events. Upon review of the literature there are only a few cases reported of acute generalized exanthematous pustulosis (AGEP) in COVID‐19 patients after treatment. Therefore, we are reporting a case of a 34-year-old male not known to have any chronic illness. His severe COVID-19 infection resolved four days prior to presentation to the Emergency Department with pustular rash on erythematous base over his face, neck, upper limbs, anterior and posterior trunk including oral cavity and tounge. The rash started after he took azithromycin, oseltamivir, ribavirin, lopinavir, hydroxychloroquine, prednisolone, ceftriaxone, clindamycin, interferon (IFN) beta, and ceftazidime for COVID-19. Skin punch biopsy was done and he was diagnosed with AGEP but it was still not known if it was related to COVID-19 or a drug-induced condition. Patient was treated with betamethasone valerate 0.1% ointment and lotion, promethazine hydrochloride 25mg tablet, paracetamol 500mg tablet, calcipotriol 50mcg/g and betamethasone 0.5mg/g gel. He discharged the same day to manage at home despite not improving. In the end, we found only a few studies that describe the cutaneous manifestations of COVID-19 infection, which were mainly case reports. We can’t be sure that AGEP is a late and severe complication of COVID-19 infection. However, AGEP could be a rare adverse effect of hydroxychloroquine therapy. Improving the knowledge about a wide range of different signs and symptoms of the disease and its severity in addition to all possible adverse treatment events and complications can improve patient safety, survival rate, and quality of life. more...

Staphylococcus aureus is a resident skin bacterium involved in the exacerbation of atopic dermatitis. Here we report that S. aureus regulates the tricarboxylic acid (TCA) cycle via the production of pyruvate for tolerance to betamethasone valerate (BV), an anti-inflammatory drug used in the treatment of atopic dermatitis. The addition of BV or clobetasol propionate to the medium among 5 different anti-inflammatory steroids delayed the growth of S. aureus. Comprehensive gene expression analysis by RNA-seq revealed that BV increased the expression of genes related to glycolysis in S. aureus. Pyruvate, a product of glycolysis, suppressed the S. aureus growth inhibition by BV. The addition of oxaloacetate, a compound in the TCA cycle biosynthesized from pyruvate, was also suppressed the inhibitory effect of BV. Malonate, an inhibitor of succinate dehydrogenase in the TCA cycle, increased the inhibitory effect of BV on the growth of S. aureus. These findings suggest that S. aureus promotes tolerance to BV, an anti-inflammatory steroid, by regulating the TCA cycle via the production of pyruvate. more...

Objective To investigate if it was feasible to quantify the renal excretion of topically applied corticosteroids by 19F MRS. Materials and methods Five participants, one healthy and four with skin diseases, were treated with ointment containing betamethasone 17-valerate. Urine samples were collected for up to 87 h after the initial application. A sample of ointment mixed with urine served as a study control. Organic fractions were obtained after sample freeze drying, and resolved in deuterated chloroform prior to acquisition of 19F MR spectra at 470 MHz for typically 8 h. Results We detected fluorine signals in 40 of the 62 fractions of organic extracts. The corticosteroid was detected in samples from all patients, ranging from 0.1 to 2.8% of the applied steroid. No fluorine signal was obtained in samples from the healthy volunteer. Discussion 19F MRS can be utilized to detect topically applied corticosteroids in urine. However, more work is required to optimize and control for extraction procedures, complete spectral assignments and reliable quantification. more...

Introduction.Inhibitors of the epidermal growth factor receptor cause the heavy dermatological adverse events, which can be the cause of change of the scheme of treatment. Acneiform rash is connected with specific inflammation of hair follicles, its weight depends on a dose of medicine and correlates with the best response to therapy at various options of tumors, in this regard effective correction of this side effect is of particular importance.Materials and methods. There were 32 patients with acneiform rash for observation; they have been divided into 3 groups. All patients received system antibacterial therapy: doxycycline 100 mg 2 times a day 10 days and topical medicines for external therapy, various on the action mechanism (tacrolimus, metronidazole, betamethasone valerate in a combination with fusidic acid). Acne Dermatology Index and Dermatology Life Quality Index were used for assessment. The received results were assesed on each visit of the patient, the final point of observations was in 3 months.Results.The significant regression of rash in all groups was in the 1st week when patients accepted doxycycline per os. Further the weakest response to therapy has shown cream with tacrolimus, the patients using gel with metronidazole has shown bigger effect, the fastest regress of Acne Dermatology Index and Dermatology Life Quality Index was observed in the patients used the combined cream with betamethasone and fusidic acid.Conclusions.The antibacterial therapy by doxycycline 100 mg 2 times a day per os at early stages of development of acneiform rash at the I—II severity gives the expressed effect and prevents deterioration of the .skin process. The combined therapy of acneiform rash of the I—II degree including doxycycline with topical cream containing a betamethasone valerate 0.1 % and fusidic acid 20 % renders the fastest and expressed effect in comparison with other combinations: the doxycycline and cream containing tacrolimus; the doxycycline and gel containing metronidazole. more...

Betamethsone valerate (BMV), a medium potency topical corticosteroid, is one of the most commonly employed pharmacological agents for the management of atopic dermatitis in both adults and children. Despite having remarkable pharmacological efficacy, these agents have limited clinical implication due to poor penetration across the startum cornum (SC). To mitigate issues related to targeted delivery, stability, and solubility as well as to potentiate therapeutic and clinical implication, the nanodelivery systems have gained remarkable recognition. Therefore, this study was aimed to encapsulate BMV into the chitosan nanoparticles (CS-NPs) for optimum dermal targeting and improved penetration across the SC. The prepared NPs were characterized for particle size, zeta potential, polydispersity index, entrapment efficiency, loading capacity, crystallinity, thermal behavior, morphology, in vitro release kinetics, drug permeation across the SC, and percentage of drug retained into various skin layers. Results showed that optimized BMV-CS-NPs exhibited optimum physicochemical characteristics including small particle size (250 ± 28 nm), higher zeta potential (+58 ± 8 mV), and high entrapment efficiency (86 ± 5.6%) and loading capacity (34 ± 7.2%). The in vitro release study revealed that BMV-CS-NPs displayed Fickian-diffusion type mechanism of release in simulated skin surface (pH 5.5). Drug permeation efficiency and the amount of BMV retained into the epidermis and the dermis were comparatively higher in case of BMV-CS-NPs compared to BMV solution. Conclusively, we anticipated that BMV-CS-NPs could be a promising nanodelivery system for efficient dermal targeting of BMV and improved anti-AD efficacy. more...

Treating dermatological pathologies with topical corticosteroids under occlusion is often more effective than nonocclusive therapy, especially in the treatment of psoriasis. Betamethasone valerate medicated plaster provides a controlled and localized method of dosing betamethasone valerate, a well-established corticosteroid with vasoconstrictive, anti-inflammatory, immunosuppressive, and antiproliferative properties. This self-adhesive plaster is approved for the treatment of inflammatory skin disorders that do not respond to treatment with less potent corticosteroids. As a patch, it offers all the clinical benefits of occlusive therapy such as increased penetration of topical agent into the area requiring treatment, enhanced skin hydration, and protection from local trauma or scratching. This translates into improved patient compliance, which is notoriously low in patients with dermatological conditions. This review presents the available clinical data from studies with betamethasone valerate medicated plaster in the treatment of psoriasis and other dermatoses and discusses its place in therapy for dermatological conditions. more...

Rowland Noakes Queensland Institute of Dermatology, Greenslopes Private Hospital Campus, Greenslopes, QLD, Australia Background: Scleroderma is traditionally managed with immunomodulatory agents such as methotrexate, mycophenolate mofetil and corticosteroids. There are anecdotal reports for, and theoretical reasons why, the anti-fibrotic agent tranilast may provide an additional treatment modality. Objective: The objective of the current study was to demonstrate if the addition of topical tranilast to an established regime resulted in an improvement in the Localized Scleroderma Assessment Tool (LoSCAT) and modified Rodnan score. Patients and methods: A small double-blinded randomized prospective study of 11 pairs of treatment sites in four patients; three with morphea and one with limited scleroderma was performed. All patients continued with their prescribed treatment and applied 0.1% betamethasone valerate in PCCA PracaSil™ (B) to the control site with 0.1% betamethasone valerate and 1% tranilast (B/T) to the comparator site over a period of 3 months. Photographs and monthly LoSCAT scores were performed on the morphea patients and a modified Rodnan score on the limited scleroderma patient. Statistical analysis was via sign test. Results: The mean baseline LoScat score at the B treated sites was 6.6 which improved to 4.3 (p= 0.16). The mean baseline LoScat score at the B/T treated sites was 5.75 which improved to 2.8 following treatment. (p=0.04) Limitations: This was a small single center study. The ideal concentration of tranilast is unknown. As all patients continued with standard management the expected response may be less than would have been anticipated in a single agent trial. Conclusion: The role of tranilast in the management in scleroderma warrants further investigation in larger trials. Keywords: morphea, limited scleroderma, tranilast, kynurenine more...

Solar ultraviolet (sUV) irradiation is a major environmental carcinogen that can cause inflammation and skin cancer. The costs and morbidity associated with skin cancer are increasing, and therefore identifying molecules that can help prevent skin carcinogenesis is important. In this study, we identified the p53-related protein kinase (PRPK) as a novel oncogenic protein that is phosphorylated by the T-LAK cell-originated protein kinase (TOPK). Knockdown of TOPK inhibited PRPK phosphorylation and conferred resistance to solar-simulated light (SSL)-induced skin carcinogenesis in mouse models. In the clinic, acute SSL irradiation significantly increased epidermal thickness as well as total protein and phosphorylation levels of TOPK and PRPK in human skin tissues. We identified two PRPK inhibitors, FDA-approved rocuronium bromide (Zemuron®) or betamethasone 17-valerate (Betaderm®) that could attenuate TOPK-dependent PRPK signaling. Importantly, topical application of either rocuronium bromide or betamethasone decreased SSL-induced epidermal hyperplasia, neovascularization, and cutaneous squamous cell carcinoma (cSCC) development in SKH1 (Crl: SKH1-Hrhr) hairless mice by inhibiting PRPK activation, and also reduced expression of the proliferation and oncogenesis markers, COX-2, cyclin D1, and MMP-9. This study is the first to demonstrate that targeting PRPK could be useful against sUV-induced cSCC development. more...

Background Chronic eczema such as atopic dermatitis imposes significant socio-econo-psychologic burdens on the affected individuals. In addition to conventional topical treatments, phototherapy is recommended for patients with extensive lesions. Although immunosuppression is believed to explain its primary effectiveness, the underlying mechanisms of phototherapy remain unsolved. Ultraviolet irradiation generates various tryptophan photoproducts including 6-formylindolo[3,2-b]-carbazole (FICZ). FICZ is known to be a potent endogenous agonist for aryl hydrocarbon receptor (AHR); however, the biological role of FICZ in chronic eczema is unknown. Objective To investigate the effect of FICZ on chronic eczema such as atopic dermatitis. Methods We stimulated HaCaT cells and normal human epidermal keratinocytes (NHEKs) with or without FICZ and then performed quantitative reverse transcriptase polymerase chain reaction, immunofluorescence, and siRNA treatment. We used the atopic dermatitis-like NC/Nga murine model and treated the mice for 2 weeks with either Vaseline® as a control, FICZ ointment, or betamethasone 17-valerate ointment. The dermatitis score, transepidermal water loss, histology, and expression of skin barrier genes and proteins were evaluated. Results FICZ significantly upregulated the gene expression of filaggrin in both HaCaT cells and NHEKs in an AHR-dependent manner, but did not affect the gene expression of other barrier-related proteins. In addition, FICZ improved the atopic dermatitis-like skin inflammation, clinical scores, and transepidermal water loss in NC/Nga mice compared with those of control mice. On histology, FICZ significantly reduced the epidermal and dermal thickness as well as the number of mast cells. Topical FICZ also significantly reduced the gene expression of Il22. Conclusion These findings highlight the beneficial role of FICZ-AHR and provide a new strategic basis for developing new drugs for chronic eczema. more...

AIMS To quantify the anti-inflammatory potency of topical corticosteroids and topical calcineurin inhibitors by measuring the contact allergic response to a diphenylcyclopropenone (DPCP) challenge in de novo sensitized human volunteers. METHODS Two randomized, double-blind, vehicle-controlled studies were performed encompassing 76 volunteers: 29 in the first and 47 in the second study. Topical drugs were applied pre- and/or post-treatment in block designs. The compounds were tested simultaneously under occluded patch tests covering DPCP-induced dermatitis. Inhibitory responses were assessed by visual scoring and measurements of the oedema thickness with ultrasound. RESULTS When applied both before and after the DPCP challenge, significant anti-inflammatory effects were seen in descending order for tacrolimus 0.1% ointment, clobetasol propionate ointment, betamethasone valerate ointment and hydrocortisone butyrate ointment, while pimecrolimus cream, hydrocortisone ointment and vehicles had no significant effect. Only tacrolimus ointment (P more...

BACKGROUND Betamethasone Valerate (BV) is a potent topical corticosteroid. Preparation of nanostructured lipid carriers (NLC) involves process parameters optimization and formulations were developed. It is available in several conventional formulations like creams and ointments which have well-known problems of frequent dosing and consequently additional side effects. The aim is to ascertain the probability of NLC as an exclusive carrier for betamethasone valerate topical application with regard to release modulation and improved therapeutic effect. METHOD Preparation of BVNLC formulations involves rigorous broad range optimization of process parameters viz. selection of lipids, surfactants, formulation technique, stirring time, stirring speed and homogenization cycles. Accordingly, optimized parameters were selected and formulation table was developed. Characterizations of developed NLC comprise particle shape, size, zeta potential, percent drug entrapment, in vitro drug release studies. The optimized NLC formulation was gelled and evaluated for ex vivo permeation studies and preclinical anti-inflammatory testing. RESULTS The permeation studies revealed that enhancement ratio of BVNLC based gel was 2.59 folds higher as compared to plain BV gel. Release models indicated anomalous (non-fickian) diffusion viz. drug release is controlled by more than one process i.e. superposition of both phenomenon, the diffusion controlled as well as swelling controlled release. Preclinical studies indicated a significant (P < 0.05) extended anti-inflammatory effect and 16.5% inhibition compared to plain gel. CONCLUSION The outcome of entire characterization advocates that the developed formulation is efficient as once a day dosing in therapy of atopic dermatitis. more...

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., BMJ Open, 12(1), e056781; 2022 more...

In the current study a high sensitive analytical method was developed for the determination of 60 steroids including glucocorticoids (GC), mineralocorticoids (MC), and progestogens (PG) in WWTP effluents and surface water using liquid chromatography with tandem mass spectrometry detection (LC-MS/MS). The limits of quantification (LOQ) ranged between 0.02 ng/L (cortisone) to 0.5 ng/L (drospirenone) in surface water and from 0.05 ng/L (betamethasone) to 5 ng/L (chlormadinone) in treated wastewater. After optimization, the developed method was applied to WWTP effluents, rivers, and streams around Germany. Numerous steroids have been detected during the sampling campaign and predominant analytes from all steroid types were determined. Moreover, the occurrence of dienogest, mometasone furoate, flumethasone pivalate, and the metabolites 6β-hydroxy dienogest, 6β-hydroxy triamcinolone acetonide, 7α-thiomethyl spironolactone, and 11α-hydroxy canrenone is reported for the first time. In addition, this study revealed the ubiquitous presence of topically applied GC monoesters betamethasone propionate, betamethasone valerate, and 6α-methylprednisolone propionate in WWTP effluents and surface water. more...

Atopic dermatitis (AD) is a chronically relapsing eczematous skin disease characterised by frequent episodes of rashes, severe flares, and inflammation. Till date, there is no absolute therapy for the treatment of AD; however, topical corticosteroids (TCs) are the majorly prescribed class of drugs for the management of AD in both adults and children. Though, topical route is most preferable; however, limited penetration of therapeutics across the startum cornum (SC) is one of the major challenges for scientists. Therefore, the present study was attempted to fabricate a moderate-potency TC, betamethasone valerate (BMV), in the form of chitosan nanoparticles (CS-NPs) for optimum dermal targeting and improved penetration across the SC. To further improve the targeting efficiency of BMV and to potentiate its therapeutic efficacy, the fabricated BMV-CS-NPs were coated with hyaluronic acid (HA). The prepared NPs were characterised for particle size, zeta potential, polydispersity index (PDI), entrapment efficiency, loading capacity, crystallinity, thermal behaviour, morphology, in vitro release kinetics, drug permeation across the SC, and percentage of drug retained into various skin layers. Results showed that optimised HA-BMV-CS-NPs exhibited optimum physicochemical characteristics including finest particle size ( more...

Macular amyloidosis (MA) represents a common variant of primary localized cutaneous amyloidosis. It has a characteristic female predominance; none of the treatment modalities described is either curative or uniformly effective in patients with macular amyloidosis. To determine the effect of fractional CO2 laser in macular amyloidosis in comparison to fractional CO2 laser-assisted drug delivery of topical steroids and topical vitamin C, the study includes 10 female patients with cutaneous macular amyloidosis aged between 20 and 62 years. Patients were treated with four sessions of fractional CO2 laser with 4 weeks interval. Laser treatments were performed using fractional CO2 laser with the following parameters (power 18 W, spacing 800 μm, dwell time 600 μs, stacking 3). The lesion is divided into three areas: area 1, treated by fractional laser only; area 2, treated by fractional laser followed by topical corticosteroid application under occlusion for 24 h; and area 3, treated by fractional laser followed by topical vitamin C serum application under occlusion for 24 h. All lesions were examined clinically and histologically before the therapy and 1 month after the end of the therapy to evaluate the degree of improvement. All treated areas show significant decrease in pigmentation score after treatment, significant drop in rippling (P value more...

To treat anal fissure, internal anal sphincterotomy may be associated with surgical risks and incidence of incontinence. Botulinum toxin injection into the anal sphincter is invasive and expensive. Headache and hypotension hindered topical treatment with glyceryl trinitrate. Greater patient compliance, potentiated efficacy, reduced side effects, and lower cost are the major advantages offered by the combination therapy. Therefore, combination topical gels of nifedipine (NIF), lidocaine hydrochloride (LDH) and betamethasone valerate (BMV) were prepared and evaluated regarding viscosity, pH, drug content, and in vitro release. Compatibility study of drug–drug and drug-excipient mixtures preceded the formulation. Stability study was performed. A prospective randomized clinical trial was conducted for six weeks to assess the efficacy of the optimized formula in the treatment of anal fissure either acute (AAF, 37 patients) or chronic (CAF, 34 patients) in comparison with three single drug market products. The compatibility was indicated except in case of LDH with each of poloxamer 407 (P407), methylparaben, and propylparaben as well as BMV with P407. The gels showed acceptable viscosity ranges, tolerated pH values, and drugs content limits complying with the pharmacopeial limit. The gel containing 10% Transcutol® (F2) was selected as optimized formula due to the significant (p more...

SummaryBackground Corticosteroids are among the most commonly used topical drugs. Contact allergy to these exists, but can be easily missed. Corticosteroid screening markers have been included in the baseline series with the aim of detecting most of the sensitized patients. Objectives To assess the prevalence of contact allergy to topical corticosteroids in Spain and examine the usefulness of corticosteroid markers to detect contact allergy to corticosteroids. Methods In total, 3699 patients referred to 20 dermatology departments across Spain for patch testing with the baseline series, including budesonide and tixocortol pivalate, were also tested with six supplementary corticosteroids (methylprednisolone aceponate, mometasone furoate, prednicarbate, clobetasol propionate, betamethasone 17-valerate, and betamethasone 17,21-dipropionate). Additionally, 2547 (68.8%) patients were tested with hydrocortisone 17-butyrate. Results Fifty-four patients showed positive reactions to at least one of all tested corticosteroids (1.46%). Thirty-nine (1.05%) reacted to at least one of the additionally tested corticosteroids; among these, 24 of 39 (61.5%) did not react to any of the corticosteroid allergy screening markers tested. Conclusions More than half of the patients who were allergic to the additionally tested corticosteroids were not detected with the corticosteroid allergy markers. An update of the corticosteroid allergy screening markers is encouraged, with consideration of group 3 corticosteroids. more...

This study aims to investigate the use of palm olein as the oil phase for betamethasone 17-valerate (BV) emulsions. The physicochemical properties of the formulations were characterized. In vitro drug release study was performed with the Hanson Vertical Diffusion Cell System; the samples were quantified with HPLC and the results were compared with commercial products. Optimized emulsion formulations were subjected to stability studies for 3 months at temperatures of 4, 25, and 40°C; the betamethasone 17-valerate content was analyzed using HPLC. The formulations produced mean particle size of 2-4 μm, viscosities of 50-250 mPa.s, and zeta potential between -45 and -68 mV. The rheological analyses showed that the emulsions exhibited pseudoplastic and viscoelastic behavior. The in vitro release of BV from palm olein emulsion through cellulose acetate was 4.5 times higher than that of commercial products and more BV molecules deposited in rat skin. Less than 4% of the drug was degraded in the formulations during the 3-month period when they were subjected to the three different temperatures. These findings indicate that palm olein-in-water emulsion can be an alternative vehicle for topical drug delivery system with superior permeability. more...

Alopecia areata (AA) is one of the most common causes of localized hair loss. There is no universally proven therapy that induces and sustains remission of hair growth in AA.To compare the efficacy and safety of topical latanoprost, minoxidil and betamethasone valerate on hair growth in patients with AA.Hundred patients with AA classified into five groups of 20 treated with: Group I, latanoprost 0.1% lotion; Group II, minoxidil 5% lotion; Group III, betamethasone valerate 0.1% solution; Group IV, combination of latanoprost lotion and betamethasone valerate solution and Group V, a vehicle lotion control group.There was a statistically significant improvement in all therapeutic groups when compared with control group and reduction of severity of alopecia tool score of scalp and beard before and after treatment for all therapeutic groups.Latanoprost, minoxidil and betamethasone valerate are effective and safe in the treatment of patchy AA. The use of latanoprost added to the therapeutic efficacy of topical betamethasone valerate in the treatment of AA and could be an effective adjunctive topical therapy for AA. more...

Although the majority of patients with psoriasis vulgaris are treated exclusively with topical therapies, research to develop more effective topical therapies that are associated with higher patient satisfaction has lagged behind the development of systemic agents. The aim of this literature review was to determine whether there is documented evidence that applying an innovative approach to improving the formulation of active ingredients commonly used in the topical treatment of psoriasis can have a positive effect on clinical outcomes and patient-reported outcomes (PROs). The Embase and PubMed databases were searched for articles published between 2001 and 2016 that made direct head-to-head comparisons of different formulations of an active pharmaceutical ingredient (API), focusing on clinical outcomes and PROs. In total, 22 publications on APIs or API combinations met the eligibility criteria (19 head-to-head clinical trials, one pooled analysis, one health-economic modelling study and one systematic review). Significant clinical benefit associated with the use of a reformulated API over an older formulation was reported in three trials of clobetasol propionate, one trial of calcipotriol, three trials of betamethasone and five trials/pooled analyses of calcipotriol/calcipotriene + betamethasone dipropionate (Cal/BD) formulations. Significantly improved PROs associated with the use of a reformulated API over an older formulation were reported in three trials of clobetasol propionate, one trial of betamethasone valerate and two trials of Cal/BD formulations. These results demonstrate that the innovative reformulation of APIs used in the treatment of psoriasis can produce therapies that attain significantly improved clinical outcomes and PROs. This suggests that improvement in topical therapy for psoriasis need not only to be achieved by the identification of new targets and the development of new APIs, but that improvement in the vehicle used to deliver existing APIs has the potential to result in significant clinical and patient benefits. more...

Background Topical corticosteroid and calcineurin inhibitor have similar therapeutic benefits in atopic dermatitis (AD), but the differences in therapeutic mechanisms of action of these agents against AD symptoms are not fully understood. Objective This study was performed to examine the different effects of topical betamethasone valerate (BMV), clobetasol propionate (CBP), and tacrolimus (TAC) on itch-related behavior and dermatitis in NC/Nga mice with AD-like symptoms. Methods AD-like dermatitis was induced in the dorsal skin of NC/Nga mice by repeated topical application of Dermatophagoides farinae body (Dfb) ointment twice weekly for three weeks. Mice with dermatitis scores over 5 were divided into five groups with equal dermatitis scores and treated with BMV, CBP, TAC, or Vaseline (Vas) once daily for two consecutive days, or were not treated (NT). Scratching behavior was analyzed using a SCLABA ® -Real system. Transepidermal water loss (TEWL) before and after treatment was measured using a Tewameter ® TM210. Skin collected from each group was analyzed histologically. Results After the second treatment, dermatitis showed significantly greater improvement in the CBP and TAC-treated groups than in the Vas-treated and NT groups. The numbers of scratching bouts were significantly lower in CBP and TAC-treated mice than in Vas-treated mice. TEWL was significantly lower in TAC-, but not in CBP-, treated mice than in Vas-treated mice. Immunohistochemical examination showed that BMV, CBP and TAC did not reduce the increased densities of epidermal protein gene product 9.5- and substance P-immunoreactive fibers. The numbers of dermal CD4-immunoreactive T cells were significantly lower in BMV and CBP-treated mice than in Vas-treated and NT mice. The numbers of dermal eosinophils were significantly lower in BMV, CBP and TAC-treated mice than in Vas-treated and NT mice, with CBP showing the strongest effect. CBP significantly reduced epidermal thickness compared with Vas and NT. There were no significant differences in the numbers of interleukin-31-immunoreactive cells and mast cells, or in expression of epidermal thymic stromal lymphopoietin among all five groups. Conclusion The therapeutic potency of TAC against AD-like symptoms, including pruritus, is equal to that of the corticosteroid CBP. Epidermal innervation of sensory nerves itself might not be related to the therapeutic effects of topical tacrolimus and corticosteroids in its early phase. more...

Purpose We assessed the role of topical betamethasone as a prophylactic agent in patients receiving radiation for head and neck malignancies. Methods and Materials This randomized, open-label, phase 3 trial was completed at a single research institute. Patients receiving curative radiation for head and neck cancer were randomized into 2 groups of 75 patients each by computer-generated permuted block random assignment. Patients in the test arm applied 0.1% topical betamethasone valerate cream once a day, after radiation. Patients in the control arm received best supportive care. The Radiation Therapy Oncology Group acute toxicity grading scale was used to assess radiation dermatitis after every fifth fraction until completion and at 2 weeks after treatment. Primary outcome in both arms was the proportion of patients who developed grade 2 and 3 acute skin reaction. The trial is registered at the Central Trial Registry of India (CTRI/2017/04/008298). Results Between April 15, 2017, and October 30, 2018,150 patients were randomized into the study, with 75 patients in each arm. Fourteen patients in the test arm and 15 patients in the control arm did not complete the intended treatment. Per the intention-to-treat analysis, 25 of 75 patients (33.3%) and 38 of 75 patients (50.7%) developed grade 2 or greater radiation dermatitis in the test and control arms, respectively (absolute difference, 17.4%; 95% confidence interval, 4%-30%; P = .032). Fifteen of 75 patients (20%) developed grade 3 reactions in the test arm compared with 18 of 75 patients (24%) in the control arm (absolute difference, 4%; 95% confidence interval, 7%-15%; P = .554). Conclusion Although prophylactic use of betamethasone significantly reduced the composite outcome of the proportion of patients developing grade 2 and grade 3 radiation dermatitis, it did not reduce the proportion of patients developing the clinically significant outcome of grade 3 radiation dermatitis. more...

Study Objective To determine the subtypes of labial adhesion (LA) and arrange treatment options accordingly. Design and Setting Patients who presented to our clinic with LA between July 2016 and February 2018 were divided into 4 groups. Location of the adhesion area, thickness of the adhesive tissue, and response to topical steroid (betamethasone valerate 0.1% ointment) therapy were identified as common features. Participants Seventy-five prepubertal girls. Interventions and Main Outcome Measures To determine the subtypes of the LA and evaluate the treatment response of patients in each subtype group. Results LA was divided into 4 subtypes according to their common characteristics. For patients with type I, 2 weeks of topical steroid treatment resulted in complete recovery (100%). For those with type II, 12 (80%) patients had complete response to topical steroid treatment for an average of 3 weeks. Type III and IV patients were completely unresponsive to topical steroid treatment. Conclusion Classification of LA patients into subtypes and determination of treatment on the basis of this classification make a major contribution in planning the treatment of patients, not by trial-and-error, but using a predetermined strategy. more...

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. more...

Low-potency corticosteroid betamethasone valerate and vitamin-A tazarotene are used in combination for effective treatment of psoriasis. There is no robust high-performance liquid chromatography analytical technique available for simultaneous estimation of betamethasone valerate and tazarotene in conventional and nanocarriers based formulations. A simple, accurate, robust isocratic high-performance liquid chromatography method was developed for simultaneous estimation of betamethasone valerate and tazarotene in topical pharmaceutical formulations. The developed method was validated as per the regulatory guidelines. The validated method was linear over the concentration range of 150-6000 ng/mL (r2 > 0.999) at 239 nm wavelength. Limits of detection and quantification of two analytes were 50 and 150 ng/mL, respectively. The %relative standard deviation for intraday and interday precision was less than 2%. The method was also evaluated in the presence of forced degradation conditions. The developed method was successfully applied for in vitro and ex vivo drug release studies of in-house designed nanoformulations. more...

Background: Umbilical granuloma so far can be treated with surgery or with silver nitrate. In limited facilities such as in remote areas where the surgeon is limited, pharmacological therapy with silver nitrate or topical steroid can be given. However, treatment with silver nitrate requires medical personnel and has unfavorable adverse effects if done by improper technique. This systematic review aimed to evaluate the effectiveness of topical steroid for treating an umbilical granuloma compared to silver nitrate therapy. Method: The literature search was done using search engines including PubMed, Embase, and Google Scholar. Literature selection was performed with limitations from 2000 to 2020 to get the novelty and written in the English language with a target population of infants less than 6 months were included. To retrieve the articles, topical corticosteroids, topical steroids, and umbilical granuloma were used as keywords. Results: The findings from the included studies show similar sample characteristics. The study conducted by Brodsgaard et al. had an older mean sample age than the study of Ogawa et al. (53.4 vs 31 days). The risk of topical steroid treatment failure on an individual study conducted by Brodsgaard et al. and Ogawa et al. was 3.0 (0.33–27.23, p = 0.33) and 0.94 (0.40–2.21; p = 0.33), respectively. Overall analysis, the risk of treatment failure was 1.09 (0.49–2.43, p = 0.82), there was no difference between the two interventions. Conclusions: One of the umbilical granuloma treatment options that can be considered is topical steroids, such as clobetasol proprionate 0.05% or betamethasone valerate 0.12%. When compared to silver nitrate, topical steroids have a longer therapeutic healing time but with a better safety profile. The non-inferiority study of topical steroids to silver nitrate has not been met yet. more...

This case report demonstrates the challenges of diagnosing and managing acute generalized exanthematous pustulosis (AGEP) presenting as septic shock. The disseminated, erythematous, pustular rash is a common feature. However, extensive organ involvement and life-threatening hypotension are unusual. The constellation of signs has not previously been documented following amoxicillin therapy. Toxic epidermal necrolysis (TEN) and toxic shock syndrome (TSS) were considered in addition to AGEP because of the systemic presentation. AGEP was diagnosed following histopathology (TEN was ruled out based on limited necrotic keratinocytes and lack of epidermal necrosis) and a negative antistreptolysin O titer (eliminated TSS). Antibiotic therapy for septic shock was provided before the diagnosis was confirmed as AGEP. Upon confirmation of the AGEP diagnosis, antibiotics were discontinued and a 5-day course of oral prednisone (40 mg/d) was initiated in addition to topical half-strength (0.05%) betamethasone valerate. The patient rapidly improved and was discharged. Outpatient patch testing confirmed amoxicillin as the culprit drug. In conclusion, it is critical to realize that AGEP cannot be ruled out with a septic shock presentation. Recent drug history is critical in recognizing an adverse drug reaction, and patch testing is useful for determining the culpable drug when the diagnosis is AGEP. more...

The soft drug approach is successful in obtaining high local therapeutic efficacy without systemic adverse effects, because soft drugs are designed to be bioconverted to inactive form by hydrolytic enzymes in systemic circulation. However, there is little information about the exact nature of these metabolic enzymes. In this study, the human enzymes for biotransformation of soft drugs were investigated. Loteprednol etabonate (LE) and etiprednol dicloacetate (ED) were designed from Δ 1 -cortienic acid (Δ 1 -CA), the inactive metabolite of prednisolone, by introducing two labile ester bonds to restore the corticosteroidal activity. We found that LE and ED were mainly deactivated in human plasma rather than the liver. Inactive monoesters were produced, but the second hydrolysis to Δ 1 -CA was much slower. ED was hydrolyzed 10 times faster than LE in plasma ( t 1/2 = 1.35 ± 0.08, 12.07 ± 0.52 h respectively). Paraoxonase 1 that attached with high density lipoprotein (HDL) was found to be the major hydrolase for LE and ED in human plasma as demonstrated by enzyme inhibition and stimulation experiments and the hydrolysis in lipoproteins-rich plasma fractions. Human serum albumin (HSA) showed slight hydrolase activity against ED but not LE. LE was slowly hydrolyzed in liver (clearance: 0.21 ± 0.04 and 2.41 ± 0.13 ml/h/kg in liver and plasma, respectively) but ED wasn’t hydrolyzed at all, so LE has superior metabolism in two sites. The difficult diffusion of HDL into tissues from blood suggests the stable presence of LE at the administration site, while ED might be deactivated by its relatively rapid chemical hydrolysis and hydrolase activity of HSA, in the interstitial fluid of the administration tissue. Moreover, deactivation in plasma and strong protein binding (around 98%) minimize the adverse effects of LE and ED in the systemic circulation. more...

BackgroundGPs prescribe topical corticosteroids to patients with chronic chilblains despite poor evidence for their effectiveness. The authors of the current study therefore decided to assess the effectiveness of topical steroids in a primary care setting.AimTo assess the effectiveness of topical application of betamethasone valerate 0.1% cream in patients with chronic chilblains.Design and settingA placebo-controlled, double-blind, crossover, randomised clinical trial in a Dutch primary care setting.MethodThe study population consisted of 34 participants suffering from chronic chilblains. Intervention was topical application of betamethasone valerate 0.1% cream twice a day for 6 weeks compared with placebo. Primary outcome was the visual analogue scale on complaints (VOC). Secondary outcome was the visual analogue scale on disability (VOD). Both were assessed with a diary of daily scores on a 100 mm visual analogue scale. The authors took ambient temperatures into account, checked for a carry-over effect, performed additional analysis, and monitored adverse effects.ResultsOn the primary outcome mean VOC, there was a difference of 0.56 mm (95% confidence interval [CI] = −2.88 to 3.99 mm) in favour of placebo (P = 0.744). On the secondary outcome mean VOD, there was a difference of 0.88 mm (95% CI = −2.22 to 3.98 mm) in favour of placebo (P = 0.567). This study found no carry-over effect and no adverse effects.ConclusionIn this study, topical betamethasone was not superior to placebo in the treatment of chronic chilblains. Topical betamethasone should not be used for chronic chilblains without new evidence. more...

Objective To examine whether in vitro and ex vivo measurements of topical drug product performance correlate with in vivo outcomes, such that more efficient experimental approaches can be reliably and reproducibly used to establish (in)equivalence between formulations for skin application. Materials and Methods In vitro drug release through artificial membranes, and drug penetration into porcine skin ex vivo, were compared with published human in vivo studies. Two betamethasone valerate (BMV) formulations, and three marketed econazole nitrate (EN) creams were assessed. Results For BMV, the stratum corneum (SC) uptake of drug in 6 h closely matched data observed in vivo in humans, and distinguished between inequivalent formulations. SC uptake of EN from the 3 creams mirrored the in vivo equivalence in man (both clinically and via similar tape-stripping experiments). However, EN clearance from SC ex vivo did not parallel that in vivo, presumably due to the absence of a functioning microcirculation. In vitro release of BMV from the different formulations did not overlap with either ex vivo or in vivo tape-stripping data whereas, for EN, a good correlation was observed. No measurable permeation of either BMV or EN was detected in a 6-h in vitro skin penetration experiment. Conclusions In vitro and ex vivo methods for topical bioequivalence determination can show correlation with in vivo outcomes. However, these surrogates have understandable limitations. A “one-size-fits-all” approach for topical bioequivalence evaluation may not always be successful, therefore, and the judicious use of complementary methods may prove a more effective and reliable strategy. more...

Introduction : Clinical studies indicate that contact allergy to glucocorticosteroids (GCS) is not rare and has been increasingly reported over the past decade. Among the risk factors for developing contact hypersensitivity to topical corticosteroids, chronic inflammatory skin diseases and polyvalent contact allergy seem to be most important. Aim : To present the structure of contact allergy in the population of patients with chronic inflammatory dermatoses (CID) and contact hypersensitivity to corticosteroids. Material and methods : Twenty-seven patients with contact allergy to GCS and chronic inflammatory dermatoses were patch tested with 28 European Baseline Series allergens and 8 corticosteroid allergens. This study group consisted of 5 patients with atopic dermatitis (AD), 15 patients with contact eczema (CE) and 7 with chronic leg eczema (CLE). Nineteen (70.4%) patients were females and 8 (29.6%) were males. Results : In the study group, the most sensitizing non-steroidal allergens were nickel sulfate (51.8%), cobalt chloride (33.3%) and balsam of Peru (29.6%). The most sensitizing corticosteroid allergens were budesonide (77.8%), betamethasone valerate and clobetasol propionate (55.5% each). A total of 77.8% of patients allergic to GCS also showed sensitivity to at least one non-steroidal allergen from the European Baseline Series. Conclusions : The most important risk factors for developing contact allergy to corticosteroids appear to be chronic inflammatory dermatoses, long disease duration, extended on-and-off topical corticosteroid use, patients presenting two or more positive patch test results and polyvalent contact allergy to metal salts and to other non-steroidal haptens. more...

Background A simple, new and efficient reversed-phase high-performance liquid chromatography method was developed and validated for the separation of most popular ingredients in skin whitening creams. Methods For RP-HPLC analysis, a Hibar(®) C18 250 mm × 4.6 mm, 5 μm column (Merck Millipore, Carolina, USA) as stationary phase with a mobile phase consisting a mixture of acetonitrile, methanol and water 40 : 40 : 20 (pH 7.0), respectively, at flow rate of 0.8 mL min(-1) (total run time 10 min) at room temperature was used. Detection was performed at 254 and 280 nm using photodiode array detector. The method was validated in accordance with ICH guidelines with respect to linearity, accuracy, precision, specificity, limit of detection and quantification. Results The method results in excellent separation of skin whitening agents in cosmetic creams. The method is specific for salicylic acid, arbutin, cortisone, hydrocortisone, betamethasone valerate and betamethasone dipropionate. The calibration curve of skin whitening agents was linear with the regression analysis showed r(2) ≥ 0.999. %RSD for inter- and intraday precision were determined as 0.461 and 0.329 for salicylic acid, 0.427 and 0.317 for arbutin, 0.360 and 0.346 for cortisone, 0.336 and 0.350 for hydrocortisone, 0.463 and 0.339 for betamethasone valerate and 0.385 and 0.372 for betamethasone dipropionate, respectively. LOD and LOQ were calculated as 0.48 and 1.20 μg mL(-1) for salicylic acid, 0.09 and 0.22 μg mL(-1) for arbutin, 0.07 and 0.18 μg mL(-1) for cortisone, 0.06 and 0.24 μg mL(-1) for hydrocortisone, 0.07 and 0.20 μg mL(-1) for betamethasone valerate and 0.02 and 0.06 μg mL(-1) for betamethasone dipropionate. The recovery of skin whitening agents were 97.18% for salicylic acid, 97.99% for arbutin, 98.30% cortisone, 97.63% for hydrocortisone, 98.65% for betamethasone valerate and 98.18% for betamethasone dipropionate, respectively. According to this study, salicylic acid is present in 87.88% skin whitening creams, arbutin in 96.97%, cortisone in 60.60%, hydrocortisone in 48.48%, betamethasone valerate in 15.15% and betamethasone dipropionate present in 12.12% cosmetic creams available in Pakistan. more...

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. more...

Die Pityriasis lichenoides et varioliformis acuta (PLEVA) ist eine inflammatorische Erkrankung, die meist bei Kindern und jungen Erwachsenen auftritt. Charakteristisch ist ein polymorphes Bild mit Papeln, Erosionen, Ulzera und hamorrhagischen Krusten, das an eine Vielzahl von Differenzialdiagnosen denken lasst. Wir berichten uber eine Patientin mit PLEVA und beschreiben mogliche Differenzialdiagnosen. more...

The present study elucidates the development of an accurate, precise and simple simultaneous estimation method for the routine analysis of Betamethasone Valerate (BV) and Tazarotene (TZ). This combination is widely used in the treatment of psoriasis. No method has been reported so far for the simultaneous estimation of BV and TZ in topical dosage forms. The method proposed by this study for the quantification of BV and TZ is the Absorption factor method. The developed method was validated as per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline. The validated method was found to be linear in a concentration range of 10-38 μg/mL and 4-14 μg/mL for BV and TZ respectively with a regression coefficient0.990. The method was validated for accuracy and precision which revealed the recovery of99.80% with RSD2.0. The method was found to be precise with RSD2% for inter and intraday. The developed method was employed for quantification of BV and TZ in lipid based nanocarriers formulation and their in-vitro drug release samples. Further, the developed method was successfully applied for the estimation of BV and TZ in the ex-vivo skin matrix. This showed that the method can sensitively determine the drugs in aqueous and biological samples. more...

Background. This placebo-controlled, double-blind study evaluated the short-term effects of betamethasone valerate (BMV) 2.25mg medicated plaster in patients with chronic lateral elbow tendinopathy (LET). Methods. Adult outpatients with LET and on-movement pain intensity ≥50 mm at a 0-100mm visual analogue scale (VAS) were randomised to receive BMV (N=101) or placebo (N=98), 12 hours/day for 4 weeks. Pain decrease from baseline to Day 28 was the primary endpoint. Other endpoints were: patient-rated tennis elbow evaluation (PRTEE), use of rescue paracetamol, tolerability at the application site. Results. Decrease in mean pain VAS from baseline to Day 28 was significantly higher with BMV vs. placebo: the difference between groups (intent-to-treat) was-8.57 mm (95% CI:-16.19 to-0.95 mm; p=0.028). Higher pain decreases in the BMV group over placebo were reported weekly during each control visit and daily in patients’ measurements on diaries. Treatment with BMV also led to higher decreases vs. placebo in PRTEE total, pain and functional disability score. Use of paracetamol was minimal. BMV plaster was well tolerated for general and local adverse events. Conclusions. BMV 2.25mg plaster was superior to placebo and well tolerated in patients with painful chronic LET. more...

Background: Patients with psoriasis have a growing interest in managing their disease through diet. Objective: This review paper aims to analyze dietary interventions for psoriasis and their outcome. Methods: Terms "psoriasis AND diet" were used to search PubMed database and 63 articles describing dietary changes influencing psoriasis were selected. Results: Low calorie diet (LCD) improves Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in conjunction with topical or systemic therapy, although LCD was unsuccessful in maintaining disease remission when patients discontinued concomitant cyclosporine or methotrexate therapy. A fish oil diet improved baseline PASI of 7.7 to 5.3 at three months and 2.6 at 6 months compared to control (PASI: 8.9, 7.8, and 7.8, respectively). A randomized, double-blind, placebo-controlled study investigating selenium supplementation in psoriasis provided no PASI improvement. Zinc supplementation with concomitant betamethasone valerate 0.0025% ointment in a randomized, double-blind, placebo-controlled study provided a mean PASI of 11.2 in the intervention group and 8.0 in the control group with no significant difference between both arms. Gluten free diet and vitamin D supplementation were also efficacious dietary changes although results were mixed. Conclusions: Dietary changes alone do not cause a large effect in psoriasis but may become an important adjunct to current first line treatments. more...

Summary Background An uncircumcised male infant with a history of urinary tract infection (UTI), physiologic phimosis, and a normal renal ultrasound is a common patient referred to pediatric urology clinics. Topical steroid creams have been shown to effectively release physiologic phimosis. Objective The objective of this study was to test the hypothesis that use of steroid cream for physiologic phimosis is associated with a lower UTI recurrence in uncircumcised male infants with normal renal ultrasounds. Study design Uncircumcised males younger than 12 months referred for a UTI with a normal renal ultrasound were included. A longitudinal data set was created, and recurrent UTIs were identified. The proportion with a recurrent UTI was compared between those who received a prescription for a steroid cream for phimosis and those who did not. The morbidity of the initial and recurrent UTIs was also described. The association of recurrent UTI with vesicoureteral reflux (VUR) was also evaluated. Results A total of 192 uncircumcised males with a median age of 5.8 months (interquartile range [IQR]: 3.5–7.9 months) were included. Twenty-seven patients were treated with a course of betamethasone valerate 0.1% cream, and 165 were not ( Summary Table ). There were no significant differences between groups in the frequency of voiding cystourethrogram (VCUG), diagnosis of VUR, or use of continuous prophylactic antibiotics (CAP). During a median follow-up of 8.7 months (IQR: 3.1–17.5 months), none of the patients treated with steroid cream had a recurrent UTI compared with 27 of 165 (16%) patients not treated (P = 0.02). Among the 173 patients whose initial UTI was febrile, recurrent febrile UTIs occurred in no treated patients and 23 of 150 (15%) untreated patients (P = 0.047). Discussion The results of this study are consistent with those of a previous randomized trial of steroid cream for physiologic phimosis which found lower recurrent UTI in those whose foreskins became retractable. In addition, the results are consistent with the declining incidence of UTIs in uncircumcised males mirroring the natural history of physiologic phimosis resolving. This study is limited by its retrospective nature and non-standardized follow-up. Conclusion The use of steroid cream for physiologic phimosis is associated with a decreased risk of recurrent UTIs in uncircumcised male infants with a normal renal ultrasound. In this group, steroid cream for physiologic phimosis is a well-tolerated and simple alternative to circumcision to potentially decrease risk of recurrent UTI. Summary table . Patient characteristics and results Patient characteristic or result All patients (n = 192) Steroid cream group (n = 27) Non-steroid cream group (n = 165) P-value Median age in months at referral (IQR) 5.8 (3.5–7.9) 6.2 (3.6–8.4) 5.7 (3.4–7.8) 0.4 a Documented Febrile UTI 173 (90%) 23 (85%) 150 (91%) 0.3 b Catheterized specimen documented 132 (69%) 20 (74%) 112 (68%) 0.7 b VCUG obtained 118 (61%) 20 (74%) 98 (59%) 0.2 b VUR diagnosed 39 (20%) 5 (19%) 34 (21%) 0.9 b CAP use at any point 27 (14%) 6 (22%) 21 (13%) 0.2 b Median follow-up time in months (IQR) 8.7 (3.1–17.5) 12.1 (6.4–17.5) 7.8 (3.0–17.7) 0.3 a Recurrent UTI 27 (14%) 0 27 (16%) 0.02 b UTI = urinary tract infection; IQR = interquartile range; VCUG = voiding cystourethrogram; VUR = vesicoureteral reflux; CAP = continuous antibiotic prophylaxis. a Wilcoxan rank-sum test. b Fisher exact test. more...

Introduction: Topical corticosteroids, available in an array of vehicles are used to control a variety of inflammatory skin diseases. Patients preferences for different vehicles may affect their willingness to use treatment. We assess corticosteroid vehicle preference and potential impact of topical characteristics on adherence and quality of life in patients with psoriasis.Methods: Subjects with psoriasis were recruited from Wake Forest University Dermatology Clinic. Subjects sampled desoximetasone 0.25% spray, betamethasone valerate 0.1% cream, triamcinolone acetonide 0.1% ointment, fluocinonide 0.05% gel, betamethasone valerate 0.1% lotion, clobetasol propionate 0.05% foam, and fluocinonide 0.05% solution in a predetermined randomized order. Subjects completed a Vehicle Preference Measure, Determinants of Adherence Measure, and a Determinants of Quality of Life Measure.Results: Patients preferences for the various products were highly variable. Regarding Determinants of Adherence, patients perception of absorption of the medication was ranked as 'quite important/extremely important' by 85% of total subjects. A majority of patients rated medication side effects as 'quite important/extremely important' when asked to consider topical characteristics effect on quality of life.Discussion: There was wide variation in patient preference for topical medication vehicles used for treating psoriasis. Several vehicle characteristics were considered important to adherence. Given the marked variation in vehicle preference, topical treatment should be individualized according to patients preferences. more...

Cutaneous lichen planus (CLP) is an inflammatory dermatosis. Its chronic relapsing course and frequently spontaneous regression hamper the assessment of treatment effectiveness. To evaluate the efficacy of available treatment modalities for CLP. PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov registry. We performed a systematic review of the current literature. All randomized controlled trials, nonrandomized case–control studies, and cohort studies with more than one treatment arm were included. The primary outcomes were complete response and time to complete response. The secondary outcomes were partial response, relapse, time to relapse, reduction of itch, the adverse event rate, and withdrawal due to adverse events. 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. Several effective treatment options are available for CLP. Further well-designed studies are warranted to investigate the efficacy of topical glucocorticoids—the current first-line therapy—as well as other treatment modalities, and the treatment of different variants of CLP. more...

Background: A ready to use betamethasone valerate 0.1% (BMV) dressing was effective and well-tolerated by patients receiving chronic plaque psoriasis treatment. Objective: Collect data related to BMV dressing used in the context of market authorization. Methods: An observational, prospective study, including 258 patients with a maximum 4-weeks-treatment of inflammatory dermatosis with BMV 2.25 mg plaster was performed. The prescription pattern was described and the disease severity assessed using a Physician Global Assessment (PGA). Patient satisfaction as well as their quality of life (DLQI) were evaluated. Clinical evaluation was performed before and after the treatment. Results: The DLQI scores improved from 10.0 ± 5.4 to 3.5 ± 3.5 points (p more...

A sensitive and comprehensive analytical method for glucocorticoids (GCs) in water samples was developed and applied to effluent of sewage treatment plants (STPs). In the present study, totally 10 natural and synthetic GCs, including cortisol, betamethasone valerate, clobetasol propionate, clobetasone butyrate, difluprednate, betamethasone, dexamethasone, betamethasone dipropionate, methylprednisolone, and prednisolone, were targeted. Analytes were extracted and concentrated using an OASIS HLB solid phase extraction cartridge. Chromatographic separation and quantification were achieved using an ultrahigh performance liquid chromatograph coupled with a tandem mass spectrometer (UHPLC-MS/MS). Method detection limits were 0.05 to 0.89 ng/L, which were 1-2 orders of magnitude more sensitive than in the previous reports. Cortisol was detected in more than half of (27 out of 50) analyzed effluent samples at concentrations in the range of ND-1.36 ng/L, indicating continuous discharge of natural GC via STP effluent. On the other hand, dexamethasone + betamethasone, prednisolone, betamethasone valerate, and clobetasol propionate were detected in 25, 8, 20, and 9 samples among 50 effluent samples, respectively, suggesting not extreme but significant administration of synthetic GCs. more...