Betamethasone Valerate Research Articles

Title: How should we use corticosteroids in lateral epicondylitis? Local injection or phonophoresis? Running title: Corticosteroid use in lateral epicondylitis

Objective: This study, it was aimed to compare and evaluate the effectiveness of local corticosteroid injection and corticosteroid phonophoresis on grip strength, functional status, pain, and quality of life in lateral epicondylitis. Materials and Methods: Patients with a diagnosis of lateral epicondylitis who underwent corticosteroid phonophoresis or local corticosteroid injection were included in the study. Patients were grouped according to the treatment they received. In the first group, corticosteroid phonophoresis was applied to the lateral epicondyle region using a continuous mode ultrasonic at 1.0 W/cm2 and 1mHz dose with 0.1% betamethasone valerate cream as a conductive agent. In the second group, corticosteroid and local anesthetic injections were applied to the lateral epicondyle region. Two groups received the supervised exercise program. Before treatment and two weeks after treatment, visual analog scale, muscle strength, grip strength, Quick Disabilities of the Arm, Shoulder, and Hand scores, and Nothingom Health Profile results for both groups were recorded from patient files and compared. Results: A total of 43 patients (23 phonophoresis, 20 corticosteroid injections) were enrolled. Although the pain, function, and quality of life of patients improved significantly with both groups, no significant difference was recorded between the groups. Grip and palmar pinch strength significantly increased in only the phonophoresis group. In addition, changing of grip and palmar pinch strength was significantly better in the phonophoresis group than in the corticosteroid injection group. Conclusion: It was determined that corticosteroid administration via phonophoresis instead of injection was more beneficial in terms of grip and palmar pinch strength.

Laboratory Glassware Cleaning Validation by Liquid Chromatographic Quantitation of Betamethasone Valerate Residues

Use of clean glassware ensures reliability of analyses that are carried out in laboratories. Glassware should be free of contaminants and residues from previous tests. It is therefore necessary to demonstrate the efficiency of glassware cleaning procedure through validation. This study aims to evaluate the cleaning efficiency of laboratory glassware by quantitation of betamethasone valerate residues in cleaned glassware. Betamethasone ointment was selected through a risk ranking process as the worst to clean product. Glassware used in analysis of this drug product was cleaned manually and residues evaluated using high performance liquid chromatography. The analysis method was validated at concentration levels of 1 - 8 µg/ml for specificity, accuracy, precision, linearity, limit of detection and limit of quantitation. The method demonstrated residue recovery of 97%. Repeatability and inter-mediate precision expressed as relative standard deviation were 1.2% and 1.4%, respectively. The calibration curve was linear over a concentration range from 2.04 to 6.13 µg/ml with a correlation coefficient of 0.9997. The detection limit and quantitation limit were 0.11 µg/ml and 0.34 µg/ml, respectively. No residue was detected in glassware that was sampled for the cleaning validation. The results indicate that the manual cleaning method is effective as the level of betamethasone residues in cleaned glassware was below detection limit and thus will not interfere with analysis of the subsequent analyte.

A clinicoepidemiological study on topical steroid misuse in a tertiary-care hospital in North India and the role of dermoscopy as a non-invasive diagnostic modality

Background: Topical corticosteroids (TCs) are one of the most frequently prescribed medications by dermatologists, yet may lead to an array of side effects due to prolonged and improper use. Because of the easy availability of topical corticosteroids as over-the-counter medications in India, these drugs are misused and abused. Objective: The objective was to determine the extent and the side effect profile of topical corticosteroid misuse/abuse in patients attending the OPD, to determine the demographic data and the reason and source of procuring TCs, and to characterize the dermoscopic findings of TSDF. Materials and Methods: This was a prospective, cross-sectional, clinical study conducted over a period of two years in which a predesigned, questionnaire-based proforma was employed. Patients above the age of fifteen reporting to the OPD giving a history of the application of a steroid cream continuously or intermittently for the minimum duration of four weeks were included in the study. A total of two hundred patients who met the clinical criteria were subjected to dermoscopic examination with a handheld dermoscope (DermLite DL4; 3Gen, U.S.; 10×). Results: A total of 2400 patients (fifteen-year-old or older) were enrolled in the study, in which 65% of the patients were females while 35% were males. Mostly, the patients procured these medicines from the pharmacist or paramedic, followed by general practitioners. The most common indications for which topical preparations were used included acne, followed by photodermatoses and ephelides. Most of the patients used combination creams, followed by potent steroids such as clobetasol propionate and betamethasone valerate. The most common side effects were erythema (74%), followed by photosensitivity (49%), hypertrichosis (47%), telangiectasia (42%), acneiform eruption (33%), contact dermatitis (21%), wrinkles (23.50%), etc. The main findings noticed on dermoscopy were irregularly dilated, branching, tortuous vessels almost interconnecting with each other in 79.78%, followed by hypertrichosis in 56.34%, white structureless areas representing atrophy in 42.33%, red dots in 7.22%, and a reddish background in 92.20%. Conclusion: The rampant use of TCs by patients for a prolonged period of time leads to a variety of side effects. Due to the topographical location, the climate of the valley, and the lighter skin type of the local population, the indications for which TCs were employed in our study group and the side effect profile were unique from the rest of the country. Dermoscopy may play a vital role in improving the diagnostic accuracy of TSDF and help us to differentiate it from close mimics.

EFFICACY OF TOPICAL MINOXIDIL 5% AND BETAMETHASONE VALERATE 0.1% VERSUS BETAMETHASONE VALERATE 0.1% MONOTHERAPY IN NON-SEGMENTAL VITILIGO

Background 
 Vitiligo is a common depigmentation disorder of the skin. Circumscribed amelanotic patches characterize it due to the destruction of melanocytes. It affects 0.5-2.0% of general population. Many combinations of medical therapies have been studied, but the optimal treatment has yet to be identified.
 Objectives 
 To evaluate the efficacy of topical minoxidil 5% plus betamethasone valerate 0.1% compared to betamethasone valerate 0.1% monotherapy in the treatment of non-segmental vitiligo
 Materials and Methods
 This open-label, comparative, therapeutic clinical trial was conducted at the Sulaimani dermatology teaching center from May 2021 to February 2022. In this trial, 30 patients with non-segmental vitiligo were divided into two groups, 15 patients each; group A treated with topical minoxidil 5% spray & betamethasone valerate 0.1% cream, and group B was treated with betamethasone valerate 0.1% cream alone, the two regimens were used twice a day and patients were followed up for three months.
 Results
 The mean percentage of depigmentation in groups A and B were (21.9%) & (16%), respectively. 
 Conclusion
 Topical minoxidil & betamethasone valerate combination achieved a higher grade of depigmentation, especially in the vitiligo of the hair-bearing areas of the head & neck. However, there was no significant difference compared to betamethasone valerate alone (P value = 0.8).

Evaluation of fractional carbon dioxide laser alone versus its combination with betamethasone valerate in treatment of alopecia areata, a clinical and dermoscopic study

Alopecia areata (AA) is a non-scarring tissue-specific autoimmune disorder. Many therapeutic modalities are available for the treatment of AA, but none has yet proven to be uniformly effective. Fractional carbon dioxide (FRCO2) laser has been introduced as a treatment modality for AA. The objective is to evaluate and compare the efficacy and safety of FRCO2 laser in treatment of AA alone or in combination with betamethasone valerate cream. 30 patients were assigned to one of the following groups, Group A FRCO2, Group B FRCO2 plus betamethasone valerate cream or Group C (betamethasone valerate cream). Patients received eight laser sessions 2 weeks apart, treatment period was 4 months. A statistically significant decrease in SALT score, dystrophic hair and a statistically significant increase in terminal hair was observed in all groups. Patient satisfaction level and reduction in SALT score were significantly higher among FRCO2 and FRCO2 plus betamethasone valerate group. However, no statistical significant difference was found between FRCO2 group and FRCO2 combined with betamethasone valerate cream group. FRCO2 laser is a safe and effective treatment modality for AA when used alone or in combination with betamethasone valerate cream. However, it was found superior to betamethasone valerate cream monotherapy.

Evaluation of oral and topical herbal formulations used in Unani medicine for treatment of psoriasis and its effect on inflammatory biomarkers – a randomized controlled clinical trial

Unani medicine, one of the complementary and alternative medicines which has mentioned the treatment options for Psoriasis, a chronic skin disease. The aim of the study was to evaluate the safety and efficacy of Unani herbal formulations in patients with psoriasis on systemic scientific parameters. This parallel group, randomized, single blind clinical trial compared Unani herbal formulations comprising of both an oral and a topical preparation with Betamethasone Valerate cream as a control. The total number of patients completing the trial was 26 in each group and treatment was given for 90 days with clinical follow-up after every 15 days. The Psoriasis Area and Severity Index (PASI) score and the inflammatory biomarkers were evaluated at the baseline and at the end of the study. There were no significant differences in general clinical characteristics ( P>0.05 ) of test and control groups and evidentally, the 95% CIs of two groups overlap for PASI score at baseline and at the end of treatment. There was improvement in the dominant features of psoriasis with decrease in PASI of patients from the baseline to the end of study in both groups. No adverse effects were observed and all the blood safety parameters remained within the normal range. The ESR and TNF-α values were found higher in psoriatic patients and there was reduction in TNF-α values in test group ( P= 0.08) with less reduction in control group ( P=0.10). The tests suggests that Unani herbal formulations can be safely and effectively used in the patients with psoriasis.

Quality by Design Approach for a Multicomponent Quantification Using HPLC-PDA and HPLC-MS: Application to Dosage Form and Biological Body Fluids

A multicomponent pharmaceutical that contains loratadine, paracetamol, and pseudoephedrine was quantified using HPLC-PDA. The three analytes were well-separated and quantified in the dosage form on a C-18 column using a gradient mobile phase. A quality by design strategy was followed to achieve the challenging separation. Screening and optimization steps were carried out to investigate the effect of many factors on the studied responses with a minimum number of runs. The ANOVA of the factorial model showed that % acetonitrile (factor A), flow rate (factor B), and pH (factor C) were significant. The detection of the analytes’ peaks was carried out using a PDA detector at 248nm for loratadine and paracetamol, and 214 nm for pseudoephedrine. The second method was SPE-HPLC-MS, where the three analytes and desloratadine, the active metabolite of loratadine, were quantified in spiked plasma and urine, using betamethasone valerate as an internal standard. The recovery of the analytes from body fluids was above 96%, and the LOQ was below 0.5 ng/mL. The validation of the developed HPLC-PDA method was achieved as per ICH guidelines, whereas the HPLC-MS method was validated according to FDA guidelines for bioanalytical method validation. The results were compared with the reported method, and no significant differences were found.

576 Difamilast, a new topical PDE4 inhibitor, ameliorates not only chronic allergic dermatitis but also idiopathic dermatitis induced by psychological stress in mice

Difamilast is a novel PDE4 inhibitor with the strongest inhibitory activity against PDE4B among the four PDE4 subtypes. Moizerto® ointment (0.3%, 1% difamilast) has been recently approved for treatment of atopic dermatitis (AD) in Japan. Exogenous antigen stimulation or psychological stress can trigger or exacerbate AD symptoms. In this study, we evaluated the therapeutic effects of difamilast, tacrolimus, and betamethasone valerate on two different mice models of dermatitis: one was chronic contact hypersensitivity (CCH) induced by repeated application of hapten every 2 days for 52 days, the other was idiopathic dermatitis due to persistent self-scratching induced by application of hapten three times a week for 16 weeks, followed by individual housing (social isolation) for 6 months. Efficacy was assessed by repeated topical application of each drug for 4 or 6 weeks after each dermatitis established. In the CCH model, difamilast ointment group significantly improved skin hyperplasia from 0.03% to 3% dose-responsibly with inhibition of inflammatory cell infiltration such as T cells, eosinophils, and neutrophils. Betamethasone valerate ointment (0.12%) improved skin hyperplasia more strongly than 3% difamilast ointment. Tacrolimus ointment (0.1%) temporarily improved skin symptoms, but eventually had no effect. In the idiopathic dermatitis model, difamilast (1%, 3%) significantly improved skin symptoms with a decrease in MIP-1 alpha and MIP-2 content. Tacrolimus (0.1%) slightly improved skin symptoms, while betamethasone valerate (0.1%) exacerbated it. Notably, difamilast ameliorates both CCH and psychological stress-induced idiopathic dermatitis. Betamethasone valerate worsened the idiopathic dermatitis probably due to skin atrophy as steroid’s side effect and tacrolimus had weak effects in both models. Therefore, difamilast is expected to be a possible treatment for AD symptoms such as chronic allergic dermatitis and psychological stress-exacerbated idiopathic dermatitis.

Fitting Pharmacodynamic Data to the Emax Model to Assess the Inherent Potency of Topical Corticosteroids.

The widespread use of topical corticosteroids (TCs) in dermatotherapy requires a consideration of their potency and benefit/risk ratios. Although there are a variety of topical corticosteroid products (TCPs) available on the market and their potencies are ranked using different classification systems, to our knowledge, no classification system to rank the inherent potencies of TC active pharmaceutical ingredients (APIs) currently exists. Most of the published classification systems for TCPs are based on randomized clinical comparative studies and/or vasoconstrictor assay (VCA) data. The objective was to apply the US FDA's VCA to classify the inherent potencies of several TCs using standardized doses to make appropriate comparisons of the relevant APIs in solutions of the same molar concentrations. Six TC APIs were assessed for their relative potencies using healthy human participants. The Emax model was used to fit skin blanching data following application of the respective TCs, and the parameters, Emax and ED50, were derived. Emax values were used as the metric to assess potency. Statistical analyses of the data revealed that the inherent potencies of fluticasone propionate, mometasone furoate, and hydrocortisone butyrate were similar. However, there was no significant difference between hydrocortisone butyrate and clobetasol propionate, while there was a significant difference between clobetasol propionate, fluticasone propionate, and mometasone furoate. Hence, the potency of hydrocortisone butyrate appears to overlap two potency classes. Furthermore, the potencies of betamethasone valerate and methylprednisolone aceponate were similar but lower than those of all of the other APIs. The application of the VCA to classify inherent potency provides a reliable method to establish a classification system for TCs. Inherent potency assessment of TCs provides information that will be useful when choosing an appropriate TC for the development of a TCP for a specific clinical indication.

Topical Betamethasone Valerate 0.1% W/V vs. Topical Ketoconazole 2% W/V: A Comparison of Efficacy in Patients of Seborrheic Dermatitis

Objective: To compare the efficacy of topical Betamethasone valerate 0.1% w/v and topical Ketoconazole 2% w/v in patients of seborrheic dermatitis.
 Study Design: Comparative prospective study.
 Place and Duration of Study: Department of Dermatology, Pak Emirates Military Hospital Rawalpindi Pakistan from Feb to Aug 2019.
 Methodology: A total of 80 patients of both genders with seborrheic dermatitis were included. Patients were divided into two groups randomly, with 40 patients in each group. Group-A patients were given topical Betamethasone valerate 0.1% w/v, while patients in Group-B were given topical Ketoconazole 2% w/v for 12 weeks. Data regarding efficacy was assessed after 12 weeks per operational definition from both groups and noted.
 Results: The mean age of patients in group A was 34.45 ± 6.73 years, and in the Group-B was 32.18 ± 6.07 years. The majority of the patients, 54 (67.50%), were between 15 to 35 years of age. Efficacy of Group-A (topical Betamethasone valerate 0.1%) was seen in 35 (87.50%) patients while in Group-B (topical Ketoconazole 2%) efficacy was seen in 25 (62.50%) patients (p-value = 0.010).
 Conclusion: This study concluded that the efficacy of topical Betamethasone valerate 0.1% w/v is higher than topical Ketoconazole 2% w/v in patients with seborrheic dermatitis.

Fast screening and confirmation of 73 common prohibited compounds in cosmetics by ultra performance liquid chromatography-quadrupole-time-of-flight high resolution mass spectrometry

建立了超高效液相色谱-四极杆-飞行时间高分辨质谱(UPLC-Q-TOF HRMS)同时快速筛查确证化妆品中73种常见禁用物质的方法。样品经饱和氯化钠溶液分散均匀后,采用含0.2%甲酸的乙腈溶液超声提取,50 mg PSA净化,以8000 r/min高速冷冻离心除脂,采用Waters Acquity HSS T3色谱柱(100 mm×2.1 mm, 1.8 μm)分离。采用多反应监测高分辨扫描模式(MRM HR),以保留时间、一级母离子精确质量数、同位素丰度比和二级子离子精确质量数实现化妆品中73种禁用物质的快速筛查和确证,基质匹配外标法定量。实验比较了不同提取溶剂、净化吸附剂、色谱条件和质谱扫描模式对73种禁用物质测定的影响,并考察了膏霜剂和水剂的基质效应。结果表明,73种禁用物质线性关系良好,相关系数(R2)>0.99;检出限为5~150 μg/kg;定量限为15~450 μg/kg;膏霜剂及水剂两种基质在3个加标水平下的回收率为60.3%~130.3%,日内、日间RSD分别为0.8%~10.0%(n=6)和1.1%~15.0%(n=3)。日常风险监测中检出磺胺甲基异噁唑、甲基泼尼松、林可霉素、对乙酰氨基酚、甲氧苄啶、阿法骨化醇、倍他米松戊酸酯、溴莫尼定、氯霉素、氯苯那敏、氯倍他索丙酸酯、克罗米通、益康唑、酮康唑、泼尼松醋酸酯和泼尼松,检出含量范围为0.5~1136.1 mg/kg。该方法准确、快速、简便,可用于化妆品中73种常见禁用物质的检测。

Characterization of a novel non-steroidal glucocorticoid receptor agonist optimized for topical treatment

Glucocorticoids (GCs) are commonly used topical treatments for skin diseases but are associated with both local and systemic side effects. In this study, we describe a selective non-steroidal glucocorticoid receptor (GR) agonist for topical use, LEO 134310, which is rapidly deactivated in the blood resulting in low systemic exposure and a higher therapeutic index in the TPA-induced skin inflammation mouse model compared with betamethasone valerate (BMV) and clobetasol propionate (CP). Selectivity of LEO 134310 for GR was confirmed within a panel of nuclear receptors, including the mineralocorticoid receptor (MR), which has been associated with induction of skin atrophy. Topical treatment with LEO 134310 in minipigs did not result in any significant reduction in epidermal thickness in contrast to significant epidermal thinning induced by treatment with BMV and CP. Thus, the profile of LEO 134310 may potentially provide an effective and safer treatment option for skin diseases compared with currently used glucocorticoids.

Allergens in corticosteroid vehicles in Saudi Arabia

Background: Both the active steroid compounds and vehicle ingredients of the topical corticosteroid products can cause allergic contact dermatitis. Purpose: The objective of the current study was to assess the presence of allergens in topical corticosteroid vehicles used in Saudi Arabia. Methods: Package inserts of topical corticosteroid products available through February 2022 were reviewed independently by two dermatologists. Topical corticosteroids were excluded if they were not approved by the Saudi Food and Drug Authority. Results: Out of 79 products examined, 49 (62%) were included in the study. Out of the 49 products, 29 (59%) had one or more allergens (a total of 38 allergens). Three topical corticosteroids were responsible for more than 80% of all allergens. These included mometasone furoate (n = 12), clobetasol propionate (n = 7), and betamethasone valerate (n = 5). The most frequent allergens were propylene glycol (66%), parabens (16%), sorbitan (13%), and lanolin (5%). Formaldehyde(s), methylchloro-isothiazolinone, and methyl-isothiazolinone were not detected in any product. Approximately 48% of the products with allergens were creams, 41% were ointments, and 10% were lotions. With two exceptions, there were no statistically significant differences in the overall presence of allergens by the type, formulation, and concentration of topical corticosteroid products. Conclusion: Almost 60% of topical corticosteroid products widely used in dermatologic clinics in Saudi Arabia had one or more vehicle allergens. Since the best treatment for contact allergy is avoidance, dermatologists should be aware of vehicle allergens in topical corticosteroids and consider the use of allergen-free products.

Preventive effects of betamethasone valerate ointment for radiation-induced severe oral mucositis in patients with oral or oropharyngeal cancer: protocol for a multicentre, phase II, randomised controlled trial (Bet-ROM study)

IntroductionThis 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...

Neurotic excoriation presenting as solitary papule: Case report

Neurotic excoriation (NE) is a repetitive manipulation of the skin that causes tissue damage. Here, we report on a 56-year-old male, otherwise healthy, who presented with a 1-year history of a recurrent slightly itchy skin lesion on his nose. Skin examination revealed a solitary round 0.5 cm × 0.5 cm pigmented crusted papule on his nose. A skin biopsy was taken, and it showed an epidermal crust with underlying mild inflammatory cell infiltrate in the upper dermis. On the basis of these clinical and pathological findings, the diagnosis of NE was made. The patient was reassured and prescribed Fucidin cream and betamethasone valerate ointment. Behavioral therapy was also initiated.

Topical Corticosteroids Utilisation and Cost Variation in Dermatology Outpatient of a Tertiary Hospital in Kathmandu

Introduction: Topical corticosteroids (TCs) are one of the important drugs prescribed in skin diseases. Cost is an important factor for compliance to treatment. Cost analysis provides the variation of costs which helps in economic benefit in the use of drugs. Thus the aim of the study was to assess the TC utilisation in Dermatology department and study its cost variation. Methods: A descriptive cross-sectional study was conducted in the out- patient of Department of Dermatology, Nepal Medical College Teaching Hospital. Patient demographic, disease, name of topical steroid, vehicle, strength, single or combination, cost of the different brands of TCs were analysed. Results: Out of 216 patients, 109 (50.5%) were females and 67 (31%) were of 21-30 years age group . Dermatitis was the most common skin condition encountered (106, 49.1%). Most common TC prescribed as single therapy was mometasone furoate 0.1%, (51, 23.6%) and betamethasone valerate 0.1% with fusidic acid, (48, 22.2%) as combination therapy. Mometasone furoate 0.1% cream, (15 gm) showed the maximum cost variation (94.7%) in single drug product while clobetasol propionate 0.05% with salicylic acid ointment (20 gm) showed the maximum cost variation (95.55%) in a combination product. Conclusion: The commonest indication of TCs use in Dermatology outpatient during our study was dermatitis, with commonest TCs prescribed being mometasone furoate. Cream was the most favoured vehicle. Cost variation was as high as 95% . Reduction in this cost variation would ease the financial burden on patients which will help in improving the patient compliance in a resource limited population.

Efficacy and Safety of Sunflower Oil for Mild to Moderate Plaque-type Psoriasis: A Double-blind, Randomized Controlled Trial

Background: Psoriasis is a chronic, complex, inflammatory disease that needs safe and effective treatment options to decrease its disease burden. Objectives: To determine the efficacy and safety of sunflower oil in mild to moderate plaque-type psoriasis at the outpatient department of a tertiary hospital. Methods: This was an 8-week, single-center, randomized, double-blind controlled trial that compared the efficacy and safety of sunflower oil + placebo cream (Group SO), betamethasone valerate cream + placebo oil (Group BC), sunflower oil + betamethasone valerate cream (Group SO-BC) in mild to moderate plaque-type psoriasis. Psoriasis Area Severity Index (PASI) was used to measure the extent of psoriasis by assessing the erythema, induration, scaling, and body surface area involvement. The difference from baseline PASI was recorded. The Dermatology Life Quality Index (DLQI) questionnaire was used to measure the impact of psoriasis on the patient’s quality of life. Results: Fifty-one patients were randomized and blinded to three treatment arms; evaluated at baseline, week 4 and 8. The proportion of patients who achieved PASI ≥50 at week 4 was 29% in Group SO, 38% in Group BC, and 60% in Group SO-BC. By week 8, Groups SO and BC achieved 80% while Group SO-BC achieved 93%. There was significant decline of PASI at week 4 and week 8 compared to baseline. The mean percentage change of PASI was highest at Group SO-BC followed by Group BC and lastly Group SO at week 4 and week 8. The mean reduction in score for scaling was significantly higher in Group SO-BC. Mean reduction in induration and erythema was not statistically significant across the three groups. There was 40-50% improvement in DLQI scores in all groups. There were no adverse events. Conclusion: This study showed that sunflower oil is effective and safe in mild to moderate plaque-type psoriasis.

Assessment of dermal bioavailability: predicting the input function for topical glucocorticoids using stratum corneum sampling

Predicting the dermal bioavailability of topically delivered drugs is challenging. In this work, minimally invasive stratum corneum (SC) sampling was used to quantify the delivery of betamethasone valerate (BMV) into the viable skin. Betnovate® cream (0.1% w/w BMV) was applied at three doses (2, 5, and 10 mg cm−2) to the ventral forearms of 12 healthy volunteers. The mass of drug in the SC was measured using a validated tape-stripping method (a) after a 4-h “uptake” period, and (b) following a 6-h “clearance” period subsequent to cream removal. Concomitantly, the skin blanching responses to the same doses were assessed with a chromameter over 22 h post-application. BMV uptake into the SC was significantly higher for the 5 mg cm−2 dose compared to those of 2 and 10 mg cm−2. In all cases, ~30% of the drug in the SC at the end of the uptake period was cleared in the subsequent 6 h. From the SC sampling data, the average drug flux into the viable epidermis and its first-order elimination rate constant from the SC were estimated as 4 ng cm−2 h−1 and 0.07 h−1, respectively. In contrast, skin blanching results were highly variable and insensitive to the dose of cream applied. The SC sampling method was able to detect a 50% difference between two applied doses with 80% power; detection of a 20% difference would require a larger sample size. SC sampling enabled quantitative metrics describing corticosteroid delivery to the viable epidermis to be determined.Graphical abstract

Treating Umbilical Granuloma with Topical Corticosteroid: A Systematic Review and Meta-analysis

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.

Effects of Intermittent Treatment with Topical Corticosteroids and Calcineurin Inhibitors on Epidermal and Dermal Thickness Using Optical Coherence Tomography and Ultrasound

Introduction: Proactive therapy with topical corticosteroids (TCSs) is the standard treatment for chronic inflammatory diseases such as atopic dermatitis; however, skin atrophy as TCS side effect remains a concern. Methods: This 16-week, evaluator-blinded, within-patient placebo-controlled, randomized study enrolled volunteers with healthy skin conditions. For 12 weeks, their volar forearm and the back of their hand were applied with hydrocortisone acetate 1% cream (HC), methylprednisolone aceponate 0.1% cream (MPA), betamethasone valerate 0.1% cream (BMV), or an active agent-free base cream (Dermatop® Basiscreme) once daily twice weekly, and pimecrolimus 1% cream (PIM) twice daily twice weekly. Epidermal and dermal thickness was measured by optical coherence tomography and high-frequency ultrasound, respectively. Furthermore, skin atrophy and telangiectasia were determined by contact dermatoscopic photography (Dermaphot®). Results: After 8 and 12 weeks, only BMV led to significant epidermal thinning on both sites. Four weeks after the end of treatment, epidermal thickness returned to baseline. No dermal thinning, atrophy, or telangiectasia was observed. Conclusions: MPA, HC, and PIM may be more suitable for repeated and prolonged treatment, especially in chronic diseases.