Topical therapy of various dermatoses with ImpoyzTM(clobetasol propionate) cream 0.025%

The most widely prescribed drugs for the treatment of a variety of dermatoses are Topical corticosteroids (TC). These medications are approved for the treatment of inflammatory and pruritic manifestations of dermatologic disorders due to their powerful symptom-relieving impact. Clobetasol propionate (CP) is the most popular (TC) used to relieve itching, redness, and oedema caused by a variety of skin disorders. Anti-inflammatory, anti-pruritic, and vasoconstrictive characteristics are all present in it. CP works by binding to cytoplasmic glucocorticoid receptors and activating glucocorticoid receptor-mediated gene expression, resulting in the production of anti-inflammatory proteins while suppressing the production of inflammatory mediators. The formulation is free from known contact allergens, such as propylene glycol, short-chain alcohols, and sorbitol-based emulsifiers, and has demonstrated hypoallergenic effects. The efficacy, safety, and clinical experience of utilizing CP 0.025% cream for the treatment of various dermatologic disorders are discussed in this case series

Identification and quantitation of related substances of super potent steroid in its topical combination drug product with vitamin D3 analogue

Clobetasol propionate is an internationally accepted common name for 21-chloro-9-fluoro-11beta,17-dihydroxy16beta-methylpregna-1,4-diene-3,20-dione 17-propionate. The combination of calcipotriol (vitamin D3 analogue) andclobetasol propionate (super potent steroid) is being used as a topical formulation for the treatment of psoriasis fromseveral years. In this work, an ultra-high performance liquid chromatography equipped with photodiode array detectorand a mass compatible mobile phase in a gradient elution is employed for the separation of five related substancesin presence of calcipotriol and its two impurities with a last eluting impurity in less than 11 minutes. A simple andefficient sample extraction procedure was developed to achieve the highest sensitivity as of today with limit of detectionand limit of quantitation of 0.03% and 0.10%, respectively, as required by industry for drug product of clobetasolpropionate and its combination products. Stationary phase with fused core particle technology is employed for theseparation of impurities. Precision of the method is found to be less than 1.0% Relative standard deviation (RSD). Thecorrelation coefficient is >0.999. Accuracy of method is ranged from 93.3% to 108.0%. This is the first reported Ultrahigh performance liquid chromatography (UHPLC) method for the estimation of five related substances of clobetasolpropionate in its combination product with calcipotriol.

Determination Method Improvement for the Two Ingredients in Ketoconazole and Clobetasol Propionate Cream / 中国药师

Objective:To establish a method for the content determination of two ingredients in ktoconazole and clobetasol propio -nate cream.Methods:HPLC was performed on a Kromasil C 18 column (250 mm ×4.6 mm, 5 μm) with the mobile phase of metha-nol-sodium acetate with gradient elution at a flow rate of 1.0 ml· min-1 .The detection wavelength was 239 nm, the column tempera-ture was 30℃and the injection volume was 10 μl.Results:The linear range was 160.30-1282.40 μg· ml-1 for ketoconazole (r=1.0000) and 4.03-32.24μg· ml-1 for clobetasol propionate (r=1.0000).The average recoveries were 100.9％(RSD=0.52％, n=9) and 100.2％(RSD=0.56％,n=9), respectively.Conclusion:The method is accurate with good specificity and high sensi-tivity, which can be used for the detection of ketoconazole and clobetasol propionate .

Comparison of compound flumethasone ointment and clobetasol propionate cream on serum and skin lesion Th cell related cytokines secreted in eczema / 中国生化药物杂志

Objective To compare the effect of compound flumethasone ointment and clobetasol propionate cream on serum and skin lesion Th cell related indicators in patients with eczema. Methods 156 patients with chronic eczema were chosen. According to the type of topical drugs, they were divided into two groups: the flumethasone group and the clobetasol propionate group. The changes of eczema treatment effect, serum and skin lesions Th cell related indicators of the two groups were compared. Results After treatment, the serum interferon-γ (IFN-γ) of the flumethasone group was (27.57 ± 5.67) pg/mL, IL-2 was (36.51 ± 8.03) pg/mL and IL-4 was (26.37 ± 5.29) pg/mL, IL-10 was (25.38 ± 4.64) pg/mL and INF-γof skin lesions was (56.53 ± 21.81) pg/L , IL-2 was (51.69 ± 15.67) pg/L, IL-4 was (159.42 ± 25.64) pg/L and (139.62 ± 24.58) pg/L, significantly lower than those of clobetasol propionate group (P <0.05), but the clinical benefit rate (94.87%) was significantly higher than (80.77%) of clobetasol propionate group (P <0.05). Conclusion Compared with clobetasol propionate cream, the effect of compound flumetasone ointment is more effective in treating eczema, and its mechanism may regulate the expressions of Th cell related cytokines.

Topical application of clobetasol propionate cream in the treatment of phimosis in prepubertal children: A report of 237cases / 中华男科学杂志

Objective@#To investigate the clinical effect of 0.02% clobetasol propionate cream (CPC) on phimosis in prepubertal children.@*METHODS@#We retrospectively analyzed the clinical data about 237 prepubertal children with phimosis present at the Outpatient Department from June 2012 to December 2015. The patients were aged 2－14 (mean 8.6) years, all treated by topical application of 0.02% CPC to the narrowed opening and adhered part of the foreskin twice a day, in the morning and evening respectively. At the time of CPC application, the foreskin was slightly retracted. We evaluated the therapeutic effect every week from the end of the first week of treatment.@*RESULTS@#Totally, 233 of the patients completed the 8-week treatment, of whom 181 (77.68%) showed full retraction of the foreskin, 28 (12.01%) experienced improvement (disappearance of the phimotic ring), and 24 (10.30%) failed to respond, with a total effectiveness rate of 89.70%. No significant local or systemic adverse reactions were observed during the treatment.@*CONCLUSIONS@#Topical application of 0.02% Clobetasol Propionate Cream is a safe, effective, painless, and inexpensive option for the treatment of phimosis in prepubertal chilodren.

The reservoir effect of topical steroids in vitiliginous skin: A cross-sectional study.

Background: Prolonged and frequent use of topical steroids may lead to decrease in effi cacy as well as many local adverse effects. Stratum corneum has a unique property of reservoir effect. Aims: To study the reservoir effect of topical steroids in a steroid-responsive condition which may enable a decrease in the dosing frequency of topical steroids. Methods: A cross-sectional study design was used. Patients with at least three vitiliginous patches of more than 2 cm2 present over the trunk or limbs were included. Exclusion criteria were topical or systemic corticosteroid use within the previous 4 weeks, antihistamine use within the previous 7 days, history of any allergy in the past and immunosuppression. Clobetasol propionate cream was applied on the fi rst vitiliginous area (site A) and fl uticasone propionate ointment was applied on the second vitiliginous area (site B). The third vitiliginous area, site C (control site) was left without applying any medication. Histamine-induced wheal suppression test was performed on each site, at the same time of the day, on every consecutive day following steroid application, until the values obtained at sites A and B approached those obtained at site C. SPSS software for Windows, version 16.0 was used for statistical analysis. The mean and standard deviation of the various studied parameters were calculated for various treatment groups and compared using analysis of variance (ANOVA) test. Results: Forty patients were included in the study. The average wheal volumes and average erythema sizes at sites A and B were signifi cantly smaller than the corresponding values at site C for up to 5 days after applying medication (P < 0.001). Limitations: The presence of a cutaneous reservoir of topical steroid was confi rmed based on its suppressive effect on the wheal and fl are response to histamine. It is not certain that the concentration that suppresses histamine-induced wheal and fl are is suffi cient for therapeutic effi cacy in vitiligo. Conclusion: The reservoir effect of topical clobetasol propionate and fl uticasone propionate persisted for 5 days in vitiliginous skin. Hence, it may be possible to reduce the frequency of topical steroid application in vitiligo.

Efficacy comparison of clobetasol propionate ointment and vitamin A acid cream in the treatment of skin papule type amyloidosis / 中国基层医药

Objective To compare clinical efficacy of clobetasol propionate ointment and vitamin A acid cream in the treatment of skin papule type amyloidosis.Methods 100 cases of skin papule type amyloidosis were randomly divided into the observation group and control group,each had 50 patients.The control group was treated with Vitamin A acid cream while the observation group used clobetasol propionate ointment for treatment.Skin lesion area,infiltration,skin color,skin itching score as well as the cure rate and efficiency were compared after 4 weeks of treatment.Results The two groups' symptoms was improved,symptom scores was decreased gradually after treatment than before,the observation group's symptom scores at 1,2,3,4 weeks were (9.35 ± 1.88),(6.54 ±2.16),(4.08 ±1.32),(2.04 ± 0.95) points which was significant better than (10.86 ± 2.08),(7.98 ± 2.57),(6.25 ± 1.44),(4.56 ± 1.18) points of the control group,the difference of two groups was statistically significant (t =6.22,6.71,7.30,7.41,all P ＜ 0.05) ;4 weeks after treatment,the observation group's efficience and cure rates were 94％ and 34％,significantly higher than 70％ and 22％ of the control group,the difference was statistically significant (x2 =9.040,8.391,all P ＜ 0.05).Conclusion Clobetasol propionate ointment has a exact effect in treatment of skinpapule type amyloidosis than vitamin A acid cream,which is worthy of clinical application.

Effect of Clobetasol Propionate and Clobetasol Butyrate with Biopolymer on Skin Inflammatory Model in Wistar Rats.

The treatment of chronic inflammatory skin conditions are not satisfactory. There is a need for better antiflammatory drugs for these conditions. This study was done to compare the efficacy of biopolymer based formulations of clobetasol propionate and clobetasol butyrate with commercially available Preparations of clobetasol in animal models of superficial skin inflammation in rats. The croton oil ear edema in rats was the chronic inflammatory model used in this study. In this model, the animals treated with clobetasol propionate and clobetasol butyrate with biopolymer showed a significant decrease in inflammation as compared to commercially available preparations of clobetasol(Tenovate and Eumosone).

In vitro skin penetration of clobetasol from lipid nanoparticles: drug extraction and quantitation in different skin layers

Clobetasol propionate (CP) is a potent topical corticosteroid that causes several cutaneous and systemic side effects. In the present work, CP was encapsulated in nanostructured lipid carriers (NLCs) to increase drug retention in the outer skin layers and improve the safety of topical therapy. NLCs were prepared using a microemulsion technique with a mixture of lecithin, taurodeoxycholate, stearic acid, and oleic acid. In vitro penetration studies were performed in a modified Franz-type diffusion cell, and porcine ears were used as a model of human skin. A simple and sensitive liquid chromatographic method was developed and validated for clobetasol determination in different skin layers. NLCs presented uniform size distribution, high zeta potentialand entrapment efficiency values (> 98%). The analytical procedure was validated according to FDA guidelines. Clobetasol recoveries from skin samples were higher than 85%, with no interference of skin components and NLC ingredients. In experiments, after 6 h, a higher drug accumulation in the stratum corneum arising from NLCs compared to aqueous CP solution was observed. Thus, the NLCs demonstrated high potential for targeting CP to the skin and ensuring drug accumulation in the stratum corneum.

Proprionato de clobetasol (CP) é um potente corticóide tópico, que apresenta vários efeitos adversos cutâneos e sistêmicos. No presente trabalho, CP foi encapsulado em carreadores lipídicos nanoestruturados (NLCs) visando aumentar a retenção do fármaco nas camadas superficiais da pele e a segurança da terapia tópica. NLCs foram preparados usando a técnica de diluição de microemulsão com mistura de lecitina, taurodesoxicolato, ácido esteárico e ácido oléico. Estudos de penetração in vitro foram realizados em células de difusão de Franz modificadas usando pele de orelha de porco como modelo de pele humana. Um método simples e sensível de cromatografia líquida foi desenvolvido e validado para a determinação de clobetasol nas diferentes camadas da pele. NLCs apresentaram distribuição de tamanho uniforme e valores elevados de potencial zeta e eficiência de encapsulação (>98%). O procedimento analítico foi validado de acordo com as diretrizes do FDA. A recuperação de clobetasol a partir das amostras de pele foi maior que 85%, sem interferência dos componentes da pele e dos excipientes das NLCs. Após 6 horas de experimento observou-se maior acúmulo do fármaco a partir das NLCs comparado à solução aquosa de CP. Dessa forma, as NLCs mostraram elevado potencial para direcionar o CP para a pele, pois elas possibilitaram o acúmulo do fármaco no estrato córneo.

Observation of therapeutic effect of Tacrolimus ointment on patients with erosive oral lichen planus / 实用口腔医学杂志

To investigate the effects of Tacrolimus ointment on patients with erosive oral lichen planus. A total of 62 cases were collected and divided into two groups randomly: 31 cases were treated with Tacrolimus ointment (treatment group), and 31 cases with clobetasol propionate ointment (control group). There was no significant difference between two groups of the effective rate and side-effect occurrence during the therapy, and relapse rate within six months after treatment. The results of the present work demonstrate that Tacrolimus ointment is an effective therapy for oral lichen planus.

Double-blind, crossover, placebo-controlled clinical trial with clobetasol propionate in desquamative gingivitis

The aim of this study was to evaluate the efficacy of a 0.05 percent clobetasol propionate ointment administered in trays to 22 patients with desquamative gingivitis in a double-blind, crossover, placebo-controlled trial. Patients received container number 1 and were instructed to apply the ointment 3 times a day for 2 weeks, and to reduce the application to once a day in the third week. Next, the patients were then instructed to discontinue the treatment for 2 weeks, and were then given container 2, used in the same way and for the same length of time as container 1. Regarding signs, 17 patients presented some improvement, while 5 experienced worsening with clobetasol propionate. With the placebo, 14 patients presented some improvement, and 8 patients presented worsening. For symptoms, there was complete improvement in 2 patients, partial improvement in 12, no response in 7, and worsening in 1 with clobetasol propionate. With the placebo, there was partial improvement in 8 patients, no response in 12 and worsening in 2. No statistically significant difference was found between clobetasol and placebo (p>0.05). Within the period designed to treat the gingival lesions of the patients, clobetasol propionate did not significantly outperform the placebo.

O objetivo deste estudo foi avaliar a eficácia do propionato de clobetasol a 0,05 por cento administrada com moldeiras em 22 pacientes com gengivite descamativa por meio de estudo duplo-cego, cruzado, placebo-controlado. Pacientes receberam bisnaga número 1 e foram instruídos a aplicar a pomada 3 vezes ao dia por um período de 2 semanas, e reduzir a aplicação para 1 vez ao dia na terceira semana. Os pacientes foram instruídos a suspender o tratamento por 2 semanas, e então receberam a bisnaga 2, usando-a da mesma maneira que o container 1. Com relação aos sinais, 17 pacientes apresentaram alguma melhora, enquanto 5 apresentaram piora com o propionato de clobetasol. Com o uso do placebo, 14 pacientes apresentaram alguma melhora, e 8 pacientes apresentaram piora do seu quadro clínico. Com relação aos sintomas, houve completa melhora em 2 pacientes, melhora parcial em 12, ausência de resposta em 7, e piora em 1 pacientes durante o uso do propionato de clobetasol. Com o uso do placebo, houve melhora parcial em 8 pacientes, ausência de resposta em 12 e piora dos sintomas em 2 pacientes. Não foi verificada diferença estatisticamente significante em nenhum dos parâmetros entre o uso do clobetasol e placebo; p>0,05. Baseado no protocolo utilizado neste grupo de pacientes, o propionato de clobetasol não demonstrou efetividade significante quando comparado ao placebo.

Effect of Topical Steroids(0.05% Clobetasol Propionate) in Children with Phimosis / 대한비뇨기과학회지

PURPOSE: We evaluated the effect of a topical steroid(0.05% clobetasol propionate[Dermovate(R)]) on phimosis. MATERIALS AND METHODS: Between May 2005 and May 2007, 30 boys with phimosis were assigned to receive topical application of Dermovate(R). Of the 30 boys, 19 boys had concealed penises. The parents of the boys were instructed to retract the foreskin gently without causing pain, and to apply the topical steroid over the stenotic opening of the prepuce twice daily for 4 weeks then for another 4 weeks if no improvement was achieved. Retractibility of the prepuce was graded from 1-6. Response to treatment was arbitrarily defined as improvement in the retractibility score(complete response, score 5 and 6; partial response, score 3 and 4; no response, score 1 and 2). The effect of treatment was studied with respect to the duration of treatment, age, and an associated concealed penis. RESULTS: The pretreatment grade in all patients was a retractibility score of 1. The mean age of the patients was 48.5+/-27.6 months(range, 7-108 months). The complete response rates in boys treated for 4 and 8 weeks were 50% and 73.3%, respectively. In boys younger than 3 years of age (n=12) and older than 3 years of age(n=18), the complete response rates were 75% and 72.2%, respectively(p=0.866). In boys with or without an associated concealed penis(n=19 and n=11, respectively), the complete response rates were 63.1% and 90.9%, respectively(p=0.199). No adverse effect was encountered in all patients. CONCLUSIONS: Our data suggest that the application of topical steroids for 8 weeks as a first line treatment of phimosis may be effective, although further studies are needed to establish the definite efficacy and safety of this procedure.

Preparation and Quality Control of Piyanjing Cream / 中国药房

OBJECTIVE : To prepare Piyanjing cream and to establish a quality control method for it. METHODS : Chemical reactions were performed to identify Piyanjing cream qualitatively. The content of main agent, clobetasol propionate was determined by HPLC. RESULTS: Chemical reactions were positive .The clobetasol propionate linearity was between 4.06～97.49?g/ml,and the average recovery was 98.67%(RSD=0.82%,n=9),the average content of clobetasol propionate was 0.492mg/g.CONCLUSION : The prescription and the preparation technique are reasonable,the cream is stable in quality,the quality control is simple ,accurate and practicable.

Comparison between narrow-band UVB with topical corticosteroid and narrow-band UVB with placebo in the treatment of vitiligo: A randomized controlled trial

BACKGROUND: Narrow-band UVB and topical corticosteroids are treatments for vitiligo. The possible synergistic effect of these modalities has not yet been investigated.OBJECTIVE: This study aims to compare the efficacy of combining narrow-band UVB (NB-UVB) and 0.05% clobetasol propionate ointment (CP) with that of NB-UVB and placebo in inducing initial and overall repigmentation and control of disease activity after 6 months of therapy. Moreover, it aims to assess the safety and determine the permanence ofrepigmentation within I year post-treatment in both regimens.METHODS: Randomized, placebo-controlled, double-blind, left-right comparison was conducted on generalized vitiligo patients with 5-50% body surface area involvement, having at least 2 bilateral, comparative lesions. CP or placebo was applied once daily on either side of the body, each combined with NB-UVB thrice weekly for 6 months.OUTCOME MEASURES: (1) number of exposures and cumulative dose (CD) of NB-UVB that induced initial repigmentation; (2) quantity of repigmentation after 6 months estimated by comparing pre- and post-treatment photographs; (3) effect on disease activity by comparing pre- and post-treatment VIDA (vitiligo disease activity) scores; and (4) permanence of repigmentation and development of new lesions within 1 year post-treatment documented by photographs.ANALYSIS: Sample size was calculated using formula for testing two proportions at 0.05 level of significance and a power of 0.80. Data was analyzed with Student t test (paired), Exact test for symmetry and Wilcoxon signed rank test, depending on the data set involved.RESULTS: Twenty-five patients were recruited, but only 20 were evaluable at the end of the study. Initial repigmentation was noted after a mean of 9.30 +/- 3.54 exposures (mean CD 1,887.8 +/- 1195.81 mJ/cm2) of NB-UVB on the CP-treated side, and after a mean of 15.85 +/- 5.61 exposures (mean CD 4,152.2 +/- 2231.9 mJ/cm2) on the placebo side. After 6 months, 55% (11/20) and 40%(8/20) of patients exhibited marked (>75 %) repigmentation in the NB-UVB with CP side, and NB-UVB with placebo side, respectively. Adverse events were minimal and transient. VIDA scores improved and repigmentation induced by both treatment regimens remained stable in majority within one year post-treatment.CONCLUSIONS: Combination NB-UVB and CP induced repigmentation earlier, requiring significantly lower cumulative dose of NB-UVB than NB-UVB plus placebo. Over all quantity and permanence of repigmentation, as well as control of disease activity and safety, were comparable in the two regimens.    

Content Determination of Clobetasol Propionate in Temeifu Pigmentum by UV Spectrophotometry / 中国药房

OBJECTIVE:To establish a method for quick content determination of clobetasol propionate in temeifu pigmentum.METHODS:UV spectrophotometry was used,and the determination was performed at the wavelength of 240nm.RES-ULTS:The detectable concentration of clobetasol propionate have a good linear relationship with its absorbability in the range of 12～18?g/ml.The inter-day and intra-day average recoveries were 99.87%(RSD=1.21%) and 99.79%(RSD=1.01%),respectively.CONCLUSIONS:The present method is rapid and accurate,which can be widely used in small hospitals not equipped with high performance liquid chromatography.

Preparation and Quality Control of Clobetasol Propionate Gel / 中国药房

OBJECTIVE:To prepare clobetasol propionate gel and to establish a method for its quality control METHODS:With carbamer941 as veihele,the 0 05% clobetasol propionate gel was prepared;An ultraviolet spectrophotometry at 241nm for the determination of clobetasol propionate in gel was established RESULTS:The calibration curve of clobetasol propionate was linear in the concentration range of 6～24?g/ml,A=0 0 324C-0 0 863(n=3),r=0 9 999 The average recovery rate was 99 44%(n=5),RSD=1 14% CONCLUSION:The preparation of clobetasol propionate gel was simple,its quality was stable;The method of quality control was rapid and accurate

Pharmacodynamics and safety evaluation of clobetasol propionate liposomes / 重庆医科大学学报

Objective:To investigate pharmacodynamics and safety of clobetasol propionate(CP)liposomes on guinea pigs with chronic dermatitis-eczema.Methods:Right ears of guinea pigs were repeatedly challenged with a small dose of dinitrochlorobenzene(DNCB)for the establishment of model of chronic dermatitis-eczema.The curative effect of CP liposomes was evaluated by cellular infiltrates in dermis and ear swelling thickening.Guinea pigs were given CP liposomes and CP cream on the right abdominal once a day for eight weeks,and the epidermal cell layers was calculated and compared.Results:CP liposomes could effectively reduce the number of cellular infiltrates in dermis and ear swelling thickening.This preparation for the application of eight weeks did not cause reduction of epidermal cells layers. Conclusion:CP liposomes is more effective on guinea pigs model of chronic dermatitis-eczema with less side effects.