Clinical and pathological analysis of 345 cases of vulvar lichen sclerosus and a preliminary study on the frequency of maintenance treatment / 中华妇产科杂志

Objective: To analyze and summarize the clinical and pathological characteristics, management, and efficacy of patients with vulvar lichen sclerosus (VLS) through a single center large sample study, and preliminarily to explore the frequency of maintenance treatment medication for VLS. Methods: The clinical data of VLS patients in Obstetrics and Gynecology Hospital of Fudan University from 2018 to 2021 were retrospectively collected. The clinicopathological characteristics (patients' age, course of disease, complicated disease history, family history, symptoms, signs and pathology), treatment and effects were retrospectively analyzed. The patients in the maintenance treatment stage were followed up regularly to explore the minimum frequency of individual medication to maintain the stability of the disease. Results: (1) General situation: a total of 345 patients with VLS were included in this study. The average age was (50.4±14.7) years (ranged from 8 to 84 years old), prevalence was highest in the 50-59 years group (30.1%, 104/345). Immune diseases occurred in 18.6% (33/177) of patients, 24.3% (43/177) of patients had allergic skin diseases, and 5.6% (10/177) of the patients' immediate family members had chronic vulvar pruritus or vulvar hypopigmentation. (2) Clinical features: the most common symptom was vulvar pruritus (96.1%, 196/204) among 204 patients with recorded symptoms. The most common sign was hypopigmentation of the vulva (96.3%, 206/214). The most common involved sites were labia minora (70.3%, 142/202), labia majora (67.8%, 137/202), and labial sulcus (59.4%, 120/202). The cumulative number of sites involved in 62 vulvar atrophy patients (2.7±1.1) was significantly higher than that in 152 non-atrophy patients (2.2±1.0; t=3.48, P=0.001). The course of vulvar atrophy was (9.3±8.5) years, which was significantly longer than that of non-atrophy patients [(6.6±5.6) years; t=2.04, P=0.046]. (3) Pathological features: among the 286 patients with electronic pathological sections, the most common pathological feature in the epidermis was epithelial nail process passivation (71.3%, 204/286). The common pathological features in the dermis were interstitial collagenization (84.6%, 242/286), and inflammatory cell infiltration (73.8%, 211/286). (4) Treatment: 177 patients received standardized treatment after diagnosis and were followed up regularly in our hospital. In the initial treatment stage, 26.0% (46/177) of the patients were treated with 0.05% clobetasol propionate cream, and 74.0% (131/177) of the patients were treated with 0.1% mometasone furoate ointment. The complete remission rates of the two methods were respectively 80.4% (37/46) and 74.0% (97/131), and there was no statistically significant difference (χ²=0.76, P=0.385). During maintenance treatment, 27.1% (48/177) of the patients took the medication twice a week, 35.0% (62/177) took the medication once a week, and 37.9% (67/177) took the medication once every 10 days. During follow-up after 6 months of maintenance treatment, there were no patients with recurrence of pruritus or progression of vulvar signs. Conclusions: The majority of VLS patients have itching, hypopigmentation, involvement of labia minora and labia majora, progressive atrophy, and inflammatory infiltration of dermis. Local treatments of mometasone furoate and clobetasol propionate have good initial therapeutic effects. The frequency exploration of individualized maintenance treatment could minimize the occurrence of adverse reactions when ensuring the stability of the patients' condition.

Fenómeno infrecuente la co-localización de alopecia frontal fibrosante y vitiligo en un varón: informe de un caso / Infrequent phenomenon the co-localization of fibrosing frontal alopecia and vitiligo in a male: case repor

La alopecia frontal fibrosante es una alopecia cicatricial que se caracteriza por la recesión de la línea de implantación frontotemporal que afecta principalmente a mujeres caucásicas en edad posmenopáusica y rara vez a hombres. Actualmente los mecanismos específicos de desarrollo continúan en estudio; sin embargo hay varias hipótesis sobre la asociación de la alopecia frontal fibrosante con otros trastornos autoinmunitarios. Se comunica el caso de un paciente masculino de 58 años con alopecia frontal fibrosante en áreas comprometidas por vitiligo. (AU)

Frontal fibrosing alopecia is a cicatricial alopecic characterized by progressive regression of the frontotemporal hairline. It usually affects postmenopausal caucasian women, and rarely men. Currently the specific mechanisms of development remain unknown, however there are several hypotheses about the association of frontal fibrosing alopecia with other autoimmune disorders. The case of a 58-year-old male patient with frontal fibrosing alopecia in areas affected by vitiligo. (AU)

Síndrome de Cushing secundario a administración tópica decorticoesteroides / Cushing Syndrome due to topical corticosteroid misuse

Los corticoesteroides tópicos son drogas muy comunes, frecuentemente utilizadas en patologías dermatológicas. Su mal uso puede causar efectos sistémicos, como el síndrome de Cushing y la supresión del eje hipotalámico ­ hipofisiario ­ adrenal. Presentamos un caso de un lactante menor de siete meses quien desarrolla un síndrome de Cushing secundario al uso de Clobetasol por una dermatitis en el área del pañal, por tiempo prolongado, sin prescripción médica. Al examen físico se evidencia obesidad a predominio central, con fascie de luna llena, hipertricosis en región frontal, telangiectasias aisladas en mejillas y cuello de búfalo. Los paraclínicos demuestran una hipercolesterolemia, hipertrigliceridemia, elevación de las transaminasas y cortisol sérico en la mañana disminuido. Se concluye que se debe informar a los padres de los efectos adversos sistémicos de los esteroides tópicos y se sugiere evitar en pacientes pediátrico(AU)

Topical corticosteroids are very common drugs used in the treatment of inflammatory skin diseases. Prolonged ormisuse of them may cause systemic adverse effects, including Cushing syndrome and hypothalamic-pituitary-adrenal axissuppression. We present a case of a seven months old maleinfant who developed iatrogenic Cushing syndrome after diaperdermatitis treatment through misuse of Clobetasol, withoutdoctor's prescription. We observe redness and a moon face, abuffalo hump, central obesity and hirsutism. Laboratory values revealed hypercholesterolemia, hypertriglyceridemia, elevationin liver enzymes and low early morning cortisol. To conclude,parents must be informed by physicians about the adverse effect of steroids and the should be avoided in very young infant(AU)

Topical corticosteroid induced ulcerated striae

Abstract We report four cases of ulcerated striae following misuse of fixed dose combinations creams containing clobetasol propionate with antifungal and antibacterial agents.

Eficácia do propionato de clobetasol 0, 05 nas lesões ulceradas da cavidade bucal / Efficacy of 0.05% clobetasol propionate in ulcerated lesions of the oral cavity

O uso tópico de Propionato de Clobetasol 0,05% em solução aquosa para lesões ulceradas na cavidade bucal é pouco divulgado nacionalmente e tem sido pouco citado em traba-lhos científicos a respeito de sua eficácia, tempo de regressão da lesão e efeitos adversos. Portanto, o objetivo deste estudo foi avaliar retrospectivamente prontuários de pacientes que foram tratados de lesões ulceradas através do uso do Propionato de Clobetasol 0,05%, no ambulatório de estomatopatologia de uma Instituição, a fim de investigar sua eficácia. Foram selecionados prontuários de pacientes que apresentaram a alteração fundamental ulcerada ou erosiva e que fizeram o uso tópico de Propionato de Clobetasol 0,05%. A aná-lise retrospectiva foi feita por um examinador, que fez a seleção da amostra seguindo os critérios de inclusão e exclusão. Foram coletadas as informações: Idade, gênero, diagnós-tico da alteração; quantidade de lesão, tempo de uso, evolução da lesão, tempo exato de regressão e presença de reações adversas. Foram incluídos 17 prontuários, dos quais cinco eram de pacientes com lesões erosivas de líquen plano, três úlceras traumáticas, três lesões liquenóides, dois eritemas multiformes, uma alergia a lactose, uma afta e uma gengivite descamativa. Todos os casos apresentaram resolução da sintomatologia, porém as altera-ções clínicas permaneceram em seis casos, embora mais leves e assintomáticas. Não foi ob-servada nenhuma reação adversa registrada no prontuário. A análise estatística não apontou associação em relação ao sexo (teste Exato de Fisher; p=0,49; p>0,05). Não foi observada diferença estatística significativa na frequência das lesões (teste exato de Fisher; p= 0,85; p>0,05). O uso do Propionato de Clobetasol 0,05% prescrito por até cinco dias se mostrou eficaz no tratamento de lesões ulceradas da mucosa bucal, principalmente para o alívio sintomático, além disso, não revelou efeitos adversos.

The treatment of ulcerated lesions of the oral cavity is usually carried out using topical analgesic drugs, anti-inflammatory corticosteroids, and alcohol-free oral antiseptics. The topical use of 0.05% Clobetasol Propionate in aqueous solution for ulcerated lesions in the oral cavity is little publicized nationally and little mentioned in scientific studies regarding its effectiveness, lesion regression time, and adverse effects. Therefore, the objective of this study was to retrospectively evaluate the medical records of patients who were treated for ulcerated or erosive lesions, using Clobetasol Propionate 0.05%, in the stomatology clinic of an institution to investigate its effectiveness. Medical records of patients who presented the fundamental ulcerated alteration and made topical use of 0.05% Clobetasol Propionate were selected. An examiner selected the sample following the inclusion and exclusion cri-teria and performed the retrospective analysis. The types of information collected were age, gender, diagnosis of the disorder, amount of injury, time of use, the evolution of the injury, exact time of regression, and presence of adverse reactions. A total of 17 medical records were included, of which five were from patients with erosive lichen planus lesions, three traumatic ulcers, three lichenoid lesions, two multiform erythema, one lactose allergy, one cold sore, and one scaly gingivitis. All cases had their symptoms solved, but, in six cases, the clinical changes remained, although milder and asymptomatic. No adverse reaction was noted in the medical record. The statistical analysis showed no association in relation to gender (Fisher's exact test; p = 0.49; p> 0.05). There was no statistically significant diffe-rence in the frequency of injuries (Fisher's exact test; p = 0.85; p> 0.05). The use of 0.05% Clobetasol Propionate, prescribed for up to five days, proved effective in treating ulcerated lesions of the oral mucosa, mainly for symptomatic relief. Furthermore, it revealed no ad-verse effects.

Granuloma annulare on the palms in an elderly patient

Abstract: Granuloma annulare is a relatively common, idiopathic, benign inflammatory dermatosis, with a varied clinical presentation that often makes diagnosis difficult. It mainly affects the extremities, such as the dorsa of the hands and feet, forearms and legs. Palmar and plantar regions are generally spared. It occurs mainly in young female patients. The presentation of the palmar variant in an elderly patient is a rarity.

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.

Pitiriasis liquenoide crónica en un adulto mayor: reporte de un caso / Pityriasis lichenoides in an older adult: report of a case

La pitiriasis liquenoide crónica (PLC) es una enfermedad benigna, que se caracteriza por tener un curso gradual, con aparición de múltiples pápulas con escamas adherentes de predominio en tronco y extremidades proximales. Con el objetivo de describir la presentación clínica, discutir el diagnóstico, diagnósticos diferenciales, tratamiento y revisar la literatura se presenta el caso de un hombre de 88 años que presentó múltiples lesiones papuloescamosas en extremidades inferiores. Se realizó biopsia cutánea que confirmó el diagnóstico de PLC. El paciente recibió tratamiento con emulsión hidratante, clobetasol tópico y claritromicina con resolución completa de las lesiones. La pitiriasis liquenoide crónica es un trastorno inflamatorio poco frecuente, de etiología desconocida que ocurre más comúnmente en adultos jóvenes y niños. Si bien la clínica es sugerente, se requiere biopsia cutánea para su confirmación diagnóstica. Es un trastorno benigno, a menudo asintomático y autolimitado, por lo que se debe valorar su tratamiento paciente a paciente. Principalmente se utilizan corticoides tópicos y antibióticos orales (tetraciclinas y eritromicina). Se ha vinculado en escasas publicaciones con el desarrollo de linfoma cutáneo y como síndromes paraneoplásicos, por lo que se sugiere realizar seguimiento.

Chronic lichenoid pityriasis (PLC) is a benign disorder, characterized by a gradual course with the appearance of multiple squamous papules with adherent scales predominating in the trunk and proximal extremities. With the objective to describe its clinical presentation, diagnosis, differential diagnosis, treatment and review literature, we present an 88-yearold male with multiple lesions in the lower extremities of one year of evolution, with papules and adherent scales. A skin biopsy was performed that confirmed the diagnosis of PLC. The patient received treatment with moisturizing emulsion, clobetasol topical and clarithromycin with complete resolution of the lesions. Chronic lichenoid pityriasis is a rare inflammatory disease of unknown etiology that occurs most commonly in young adults and children. Although the clinic is suggestive, a skin biopsy is required for diagnostic confirmation. It is a benign disorder, often asymptomatic and self-limiting, so its patientto- patient treatment should be assessed. Topical corticosteroids and oral antibiotics (tetracyclines and erythromycin) are used. It has been linked in few publications with the development of cutaneous lymphoma and as paraneoplastic syndromes, so it is suggested to follow up.

Bilateral clear cell acanthoma of the areola and nipple: good response to topical corticosteroids

Abstract: Clear cell acanthoma is a rare, epidermal tumor not common in the area of the nipples; indeed, the literature describes only 8 cases, all showing unilateral presentation. We here report the first case of bilateral clear cell acanthoma with good response to topical corticosteroids. Case report: A sixteen-year old girl presented with 2 excrescent, fleshy, and exudative tumor masses in both nipples and areola mammae. A biopsy was conducted and confirmed clear cell acanthoma histopathologically. Treatment with strong corticosteroids resulted in rapid improvement and resolution. After one year of follow-up, the patient developed atopic dermatitis. Discussion: We describe the first case of bilateral clear cell acanthoma localized in the nipple/areola that resolved with powerful corticosteroids, suggesting a reactive etiology of the lesion.

The measurement of serum corticosteroid level in atopic dermatitis patients associated with application of topical corticosteroids

PURPOSE: Most of the atopic dermatitis (AD) patients and their parents refuse topical treatment because of concern about generalized side effect due to systemic absorption of topical corticosteroids. Therefore, a large number of studies reported difficulty in properly controlling in AD. However, investigations of the percutaneous absorption of topical corticosteroids are still insufficient. METHODS: One hundred nine patients who visited our atopy clinic and diagnosed as AD by a physician from January 2005 to January 2012 were enrolled. We examined serum corticosteroid (clobetasol propionate, hydrocortisone) level by liquid chromatography (LC) coupled with a tandem mass spectrometric (MS/MS) method. RESULTS: We developed the LC-MS/MS method to determine corticosteroids (clobetasol propionate, hydrocortisone) in sera of AD patients. Also, we confirmed precision, accuracy, limit of detection, limit of quantification, absolute recovery, and relative recovery of the experimental methods. We could not detect clobetasol propionate or hydrocortisone in sera of 109 AD patients using the newly developed LC-MS/MS method. CONCLUSION: Regardless of age, the severity and illness duration of AD, clobetasol and hydrocortisone were not detected in sera. Although there are many other factors of determining systemic absorption of topical medications, our results showed that topical corticosteroids applied for several years in AD patients may be under the limit of detection in their sera by the LC-MS/MS method.

Vulvitis de Zoon: caso clínico / Zoon vulvitis: clinical case

Se presenta un caso de una paciente de 84 años con vulvitis de Zoon. Se trata de una dermatosis vulvar de etiología incierta, muy poco frecuente, que ocasiona sintomatología inespecífica de prurito y escozor vulvar de larga evolución, acompañados de una o varias lesiones focales circunscritas y eritematosas de difícil diagnóstico clínico. Se insiste en la necesidad de realización de biopsia vulvar para obtención de un diagnóstico histológico de certeza. Se comentan las opciones terapéuticas actuales descritas en la literatura aunque no existe un tratamiento de elección.

An 84 year old female patient with Zoons vulvitis case is reported. It is a rare vulvar dermatosis of unknown etiology, with unspecific symptoms such as pruritus and vulvar stinging, both developed over a long period of time, accompanied with focal erythematous injuries. As a clinical diagnosis remains difficult, it is essential that a biopsy is obtained for accurate histological diagnosis. Despite different therapeutic options available, there is no consensus on a standardized treatment.

Frequency of serum cortisol suppression in patients using 0.05% clobetasol propionate as topical steroid for more than 3 weeks

Objective: To determine the frequency of serum cortisol suppression in patients using 0.05% clobetasol propionate as topical steroid for more than 3 weeks

Study Design: Cross sectional Study

Place and Duration of Study: Both outdoor and indoor patients of Dermatology Department, Military Hospital [MH] Rawalpindi for duration of 6 months i.e. from 18[th] April 2012 to 17[th] October 2012 were selected

Patients and Methods: A total of 189 patients were included in the study. Non-probability purposive sampling technique was used. Early morning [0800 hrs] serum for cortisol levels was taken before starting the treatment and same was repeated after 3 weeks at AFIP. Effect modifiers like age and gender were controlled through stratification. The data was analyzed using SPSS version 10. The quantitative variables like age, duration of illness were calculated by taking standard deviation and mean whereas the qualitative variables like gender, suppression of serum cortisol levels were calculated by taking percentages and frequency. Frequency of serum cortisol suppression was presented according to gender and age groups

Results: Majority of the patients selected were between 31-40 years i.e. 44.98% [n=85]. Gender distribution was 61.90% [n=117] males and 38.10% [n=72] females. Frequency of serum cortisol suppression in patients using 0.05% Clobetasol propionate as topical steroid for more than 3 weeks was seen in 33.33% [n=63]

Conclusion: The frequency of serum cortisol suppression was significantly higher amongst patients using clobetasol propionate 0.05%. Therefore patients prescribed clobetasol propionate 0.05% topically should be checked for serum cortisol suppression regularly if the application is intended to be used for more than 3 weeks

Comparative histological study on wound healing on rat's skin treated with Mitomycin C or Clobetasol propionate

PURPOSE:To compare histologically the action of Mitomycin C and that of Clobetasol propionate for surgical wound healing in rats.METHODS:A circular skin fragment was surgically removed from 57 Wistar rats. Twenty-two animals were treated with Mitomycin C with topical medication in a single dose, 22 with Clobetasol propionate with a cream medication once a day for 15 days and 13 did not receive any medication. The animals were euthanized 30 and 60 days, and the scars subjected to histological examination.RESULTS: The histological analysis on the samples did not show statistically significant differences regarding the quantities of fibroblasts, fibrocytes and vascular proliferation in the three groups, in the evaluations after 30 and 60 days. In the treated groups with Mitomycin C and Clobetasol there was a decrease in collagen concentration over the 30-day period and an increase in collagen concentration over the 60-day period, in comparison with the control group.CONCLUSIONS: The actions of Mitomycin C and Clobetasol were equivalent and not interfere in fibroplasias and in angiogenesis. Both drugs initially cause a decrease in collagen over a 30-day period and an increase over a 60-day period, demonstrating a delay in the wound healing.

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.

Linear psoriasis: case report on three year old child

Atypical and unusual locations of psoriasis are very frequent. However, localized linear psoriasis is rare, with few cases described in the literature. It is characterized by a linear distribution of psoriasis lesions along Blaschko lines. We report the case of a three years old child, who presented unilateral erythematous scaly plaques arranged along Blaschko lines in the left hemithorax, with no associated symptoms and no lesions in other parts of the body. The differentiation of linear psoriasis from other linear dermatoses is not easy. The combination of a thorough history, a careful examination of the skin and histopathology are essential to ensure the correct diagnosis and appropriate treatment.

Efficacy of topical tacrolimus 0.1% and clobetasol propionate 0.05% in the treatment of alopecia areata

Objective: To assess the efficacy of tacrolimus and clobetasol propionate in the treatment of alopecia areata

Methods A clinical trial was carried out in the department of Dermatology and Venereology, Dhaka Medical College Hospital, Dhaka, Bangladesh from May 2013 to April 2014. Total sixty patients were enrolled and divided into group A and group B. Thirty of group A patients were treated with topical tacrolimus and thirty of group B patients were treated with topical clobetasol propionate

Results: In group A, the duration of illness ranged from 2 months to 36 months and in group B, from 1 month to 24 months. Among the patients of group A and B, 25 [83.3%] and 27 [90%] patients improved, respectively. After 16th week of treatment, slight response in 6 [20%] and 4 [13.3%] and moderate response in 18 [59.4%] and 22 [63.2%] and marked response in 1 [3.3%] and 1 [3.3%] was seen in group A and group B, respectively. No significant difference was observed [p value = 0.648]

Conclusion: Both the drugs, clobetasol propionate and tacrolimus when used individually, were found to be equally effective in the treatment of alopecia areata and tacrolimus ointment 0.1% can be used as an alternate therapeutic modality

Evaluation of Efficacy, Safety and Tolerability of a Combination of Clobetasol, Neomycin and Miconazole Versus Betamethasone, Clotrimazole and Neomycin Versus Betamethasone, Gentamycin and Miconazole in Subjects with Eczematous Disorders Associated with underlying Tinea or Yeast Infections.

Lobate GM Neo, 15 mg is a triple drug combination of a steroid clobetasol with anti-fungal miconazole and antibacterial neomycin in treatment of Eczematous disorders associated with underlying Tinea or Yeast Infections. Aims and Objectives: The study was designed to evaluate the efficacy, safety and tolerability of a combinations of clobetasol, neomycin and miconazole (Group A) versus betamethasone, clotrimazole, neomycin (Group B) versus betamethasone, gentamicin, miconazole (Group C) in subjects with any type of eczematous disorder associated with underlying tinea or yeast infection. Materials and Methods: This was an open label, parallel group, randomized comparative study. The primary endpoint analyzed was improvement in clinical score from baseline at the end of day 7 and other primary endpoint like hyperpigmentation were analyzed by the visual analogue scale of 1 to 10 at the end of day 7. Results: Thirty-six subjects were randomized to three groups. The clinical score showed a significant reduction from baseline at the end of day 7 in all the groups, i.e. 82.9%, 81.3% and 85.6% in Group A, B and C respectively. However, the difference between the groups were not statistically significant. Mean hyper pigmentation score showed significant decrease of 82.9% in Group A, 81.6% in Group B and 92.2% in Group C from baseline at the end of day 7. Conclusion: The triple combination of antifungal, antibacterial and potent steroid was found to be efficacious, safe and tolerable in reducing signs and symptoms (scaling, inflammation, burning and itching) of eczematous disorder associated with underlying tinea/yeast infection.

An Open, Comparative, Randomized, Parallel, Post Marketing, Multicentric Trial to Compare the Safety and Efficacy of Formula A (Ofloxacin + Ornidazole + Terbinafine Hydrochloride + Clobetasol Propionate) versus Formula B (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate), Formula C (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) and Formula D (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) in the Treatment of Patients with Vaginitis.

Vaginitis is among the most common conditions for which women seek medical care, with vaginal discharge accounting for approximately 10 million office visits each year. Since there are no published studies till date that evaluated the Clinical Effectiveness and Safety of Topical Cream of Formula A [Ofloxacin (0.75 % w/w) + Ornidazole (2% w/w) + Terbinafine Hydrochloride (1% w/w) + Clobetasol Propionate (0.05% w/w)] compared to Formula B [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], Formula C [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], and Formula D [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], in mild to moderate vaginitis, hence we undertook this randomized controlled Post Marketing Multicentric trial. Materials and methods: Female subjects diagnosed with mild to moderate symptoms of Vaginitis were eligible and those fulfilling the subject selection criteria were randomized to receive either Formula A, Formula B, Formula C or Formula D for 14 days. The Primary efficacy measures were assessment of symptoms of Vaginitis i.e. vaginal pruritis, vaginal irritation, vaginal soreness or pain, dyspareunia, vaginal erosion and vaginal inflammation and Secondary efficacy measures were assessment of Physical characteristics of vaginal discharge, assessment of pH of vaginal discharge and Microbiological evaluation. Assessment of Safety was done by recording the occurrence of adverse drug reactions. Results: The clinical success rates were comparable and even far better in case of Formula A group (in vaginal pain, Dyspareunia and vaginal erosion it was 100 %, in case of vaginal inflammation it was 92.655 % while in case of vaginal irritation, it was 94.767 % and vaginal pruritus, it was 87.096 %). Adverse events were mild and self limiting while it was totally absent in case of Formula A group. Conclusion: Topical Cream of Formula A is safe and effective for the treatment of mild to moderate vaginitis.