Efficacy of topical clotrimazole vs. topical tolnaftate in the treatment of otomycosis. A randomized controlled clinical trial / Eficácia do clotrimazol tópico versus tolnaftato tópico no tratamento da otomicose: um ensaio clínico controlado randomizado

Abstract Introduction: Otomycosis, an infection of the ear canal by fungi, is prevalent in hot and humid weather. Nevertheless, there is not sufficient evidence for the effectiveness of different topical antifungal treatments. Tolnaftate, is a topical antifungal agent described to be effective in the treatment of otomycosis. Currently there are not sufficient studies that prove its efficacy. Objectives: To compare the efficacy of clotrimazole and tolnaftate administration in the treatment of otomycosis. Material and methods: A controlled, randomized and open clinical trial included patients diagnosed with fungal external otitis who were treated with topical antifungals, randomized into two treatment groups: (1) clotrimazole cream; (2) tolnaftate solution. They were microscopically evaluated at one and two weeks of treatment to determine resolution of disease. Recurrence and complications were recorded. Demographic and clinical variables were collected and analyzed. Follow-up and final outcomes (absence of infection) were compared between groups. Results: Forty eight patients were included, 28 in the clotrimazole group and 20 in the tolnaftate group. Spring was the weather most commonly associated with otomycosis, while otic manipulation was the risk factor more common in both groups. Predominant symptoms were itching and otic fullness. Aspergillus niger organism was isolated most frequently. Treatment with clotrimazole resulted in 75% resolution vs 45% resolution with treatment with tolnaftate at one week of treatment (p = 0.007). The Tolnaftate treatment group demonstrated higher recurrence rates and treatment failures, 20% and 15% respectively. Conclusions: Clotrimazole cream treatment is more effective than tolnaftate for uncomplicated otomycosis. More studies are needed to corroborate our results.

Resumo Introdução: Otomicose, uma infecção fúngica do canal auditivo externo, é prevalente em climas quentes e úmidos. No entanto, a literatura não apresenta evidências suficientes sobre os diferentes tratamentos antifúngicos tópicos. O tolnaftato é um antifúngico tópico descrito como eficaz no tratamento da otomicose; entretanto, sua eficácia não está suficientemente comprovada. Objetivo: Comparar a eficácia do uso de clotrimazol e tolnaftato no tratamento da otomicose. Material e método: Ensaio clínico controlado e randomizado; incluiu pacientes diagnosticados com otite externa fúngica tratados com antifúngicos tópicos, randomizados em dois grupos de tratamento: 1) clotrimazole (creme); 2) solução de tolnaftato. Eles foram avaliados microscopicamente uma e duas semanas após o início do tratamento para avaliar a resolução da doença. Recorrência e intercorrências foram registradas; além disso, as variáveis demográficas e clínicas foram coletadas e analisadas. Os dados do acompanhamento e desfechos finais (ausência de infecção) foram comparados entre os grupos. Resultados: O estudo incluiu 48 pacientes, 28 dos quais foram alocados ao grupo clotrimazole e 20 ao grupo tolnaftato. A primavera foi a estação mais comum; a manipulação foi o fator de risco mais comum em ambos os grupos. Os sintomas mais comuns foram coceira e plenitude auricular. Aspergillus niger foi o micro-organismo mais comumente isolado. Após uma semana, o tratamento com clotrimazol apresentou uma taxa de resolução de 75% vs. 45% com o tratamento com tolnaftato (p = 0,007). O tratamento com tolnaftato apresentou maiores taxas de recidiva e falhas: 20% e 15%, respectivamente. Conclusões: Em casos de otomicose não complicada, o uso de clotrimazol (creme) é mais eficaz do que o de tolnaftato. Mais estudos são necessários para corroborar os presentes resultados.

Comparison of the recovery rate of otomycosis using betadine and clotrimazole topical treatment / Comparação da taxa de recuperação de otomicose com o uso de tratamento tópico com betadina e clotrimazol

Abstract Introduction Otomycosis is a common diseases that can be associated with many complications including involvement of the inner ear and mortality in rare cases. Management of otomycosis can be challenging, and requires a close follow-up. Treatment options for otomycosis include local debridement, local and systemic antifungal agents and utilization of topical antiseptics. Objective This study was designed to compare the recovery rate of otomycosis using two therapeutic methods; topical betadine (Povidone-iodine) and clotrimazole. Methods In this single-blind clinical trial, 204 patients with otomycosis were selected using a non-probability convenient sampling method and were randomly assigned to two treatment groups of topical betadine and clotrimazole (102 patients in each group). Response to treatment was assessed at 4, 10 and 20 days after treatment. Data were analyzed using the independent t-test, Chi-Square and Fisher exact test in SPSS v.18 software, at a significance level of p < 0.05. Results The results showed that out of 204 patients with otomycosis, fungi type isolated included Aspergillus in 151 cases (74%), and Candida albicans in 53 patients (26%). On the fourth day after treatment, 13 patients (13.1%) in the group treated with betadine and 10 patients (9.8%) in the group treated with clotrimazole showed a good clinical response to treatment (p = 0.75). A good response to treatment was reported for 44 (43.1%) and 47 patients (46.1%) on the tenth day after the treatment (p = 0.85); and 70 (68.6%) and 68 patients (67.6%) on the twentieth day after treatment (p = 0.46) in the groups treated with betadine and clotrimazole, respectively. The response to treatment was thus not significantly different in the two groups. Conclusion In the present study the efficacy of betadine and clotrimazole was the same for the treatment of otomycosis. The result of this study supports the use of betadine as an effective antifungal in otomycosis treatment, helping to avoid the emergence of resistant organisms.

Resumo Introdução A otomicose é uma das doenças comuns associadas a muitas complicações, como envolvimento da orelha interna e mortalidade em casos raros. O tratamento da otomicose pode ser realmente desafiador e requer um acompanhamento rigoroso. As opções de tratamento para otomicose podem incluir desbridamento local, agentes antifúngicos locais e sistêmicos e uso de antissépticos tópicos, os medicamentos tópicos recomendados para o tratamento da otomicose. Objetivo Comparar a taxa de recuperação de otomicose utilizando dois métodos terapêuticos de betadina tópica (povidona-iodo) e clotrimazol. Método Neste ensaio clínico simples cego, 204 pacientes com otomicose foram selecionados utilizando-se método de amostragem de não probabilidade conveniente e randomizados para dois grupos de tratamento, com betadina tópica e com clotrimazol (102 pacientes em cada grupo). A resposta ao tratamento foi avaliada aos 4, 10 e 20 dias após o tratamento. Os dados foram analisados utilizando o teste t independente, qui-quadrado e teste de Fisher no software SPSS v.18, com nível de significância de p < 0,05. Resultados Os resultados mostraram que dos 204 pacientes com otomicose, os tipos de fungos isolados incluíram Aspergillus em 151 casos (74%) e Candida albicans em 53 pacientes (26%). No quarto dia após o tratamento, 13 pacientes (13,1%) no grupo tratado com betadina e 10 pacientes (9,8%) no grupo tratado com clotrimazol apresentaram boa resposta ao tratamento (p = 0,75). Uma boa resposta ao tratamento foi relatada para 44 (43,1%) e 47 pacientes (46,1%) no décimo dia após o tratamento (p = 0,85); e 70 (68,6%) e 68 pacientes (67,6%) no vigésimo dia após o tratamento (p = 0,46) no grupo tratado com betadina e clotrimazol, respectivamente. Assim, a resposta ao tratamento não foi significativamente diferente nos dois grupos. Conclusão No presente estudo, a eficácia da betadina e do clotrimazol foi a mesma no tratamento da otomicose. O resultado deste estudo apoia o uso de betadina como um antifúngico eficaz no tratamento da otomicose que pode ajudar a evitar o surgimento de organismos resistentes.

Comparison of oral itraconazole versus topical clotrimazole in treatment of pityriasis versicolor

Objective: To compare the efficacy of single dose of oral itraconazole 400mg with 1% topical clotrimazole in the treatment of pityriasis versicolor

Study Design: Randomized controlled trial.

Place and Duration of Study: Dermatology department, Military Hospital Rawalpindi, from Jun 2015 to Dec 2015

Material and Methods: A total of 60 patients of pityriasis versicolor fulfilling the inclusion criteria were selected from dermatology OPD after written informed consent and approval from the hospital ethical committee

Patients were divided into two treatment groups using random numbers table. Group A received single dose of itraconazole capsule [400mg] and group B received 1% clotrimazole cream twice daily application for 2 weeks

Patient evaluation included detailed history, clinical examination and direct microscopy of skin scrapings for fungal hyphae at the baseline, at the end of 2[nd] and 6[th] week of treatment. Efficacy of treatment was assessed on the basis of clinical and mycological cure

Results: At the end of 2 weeks of treatment, clinical cure was seen in 23 [76.6%] and 29 [96.6%] patients [p=0.05] and mycological cure in 20 [66%] and 26 [86.6%] patients in group A and B respectively [p=0.06]. At follow up [end of 6 week] 21 [70%] and 28 [93.3%] patients were cured clinically [p=0.02] while 18 [60%] and 27 [90%] patients were cured mycologically [p=0.007] in group A and B respectively

Conclusion: Topical clotrimazole [1%] was found more effective than single dose of oral itraconazole in the treatment of pityriasis versicolor

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.

[ comparative evaluation of terbinafin 1% cream and clotrimazole 1% in the treatment of pityriasis versicolor]

Terbinafine, a member of the allylamines group, is a new class of antimycotic agents. The aim of this study was to compare the antifungal efficacy of Terbinafine 1% with that of Clotrimazole 1% in the patients with Pityriasis Versicolor. This controlled-clinical trial study was performed on 53 patients [28 males and 25 females] with a mean age of 25 years old. The patients were divided into two groups. The first group was treated with Terbinafine 1% and the second group with Clotrimazole 1% twice a day. The patients were evaluated both clinically and mycologically at the beginning of the study as well as the end of the second and the fourth weeks. The findings were analyzed using Fisher Exact and Chi Square tests. In the 2[nd] week of the treatment, clinical cure was observed in 44.4% of the patients in the first group [Terbinafine recipients] and in 48% of those in the second group [Clotrimazole recipients] [P=0.90]. At the end of the fourth week, the lesions disappeared in 89% and 81% of the first and second groups, respectively [P=0.467]. Mycological cures were observed in the 2[nd] week in 48% of the first group and 38% of the second group [P=0.477] which respectively increased to 92.5% and 88.5% by the fourth week [P=0.66]. although the fungicidal activity of both drugs were found to be almost similar, Clotrimzole is recommended because it is more available and less expensive

Uso de medicamentos en mujeres embarazadas en el servicio de obstetricia del Hospital Escuela Doctor Oscar Danilo Rosales Arguello León del 1 enero del 2005 al 3 diciembre 2007 / Use of medications in pregnancy women in the service of obstetrics of the Hospital School Doctor Oscar Danilo Rosebushes Arguello León of the 1 January of the 2005 to the 3 December 2007

Presenta estudio descriptivo, prospectivo de corte transversal, realizado en el Departamento de Obstetricia ubicado en el segundo piso del Hospital Escuela Dr. Oscar Danilo Rosales. La población del estudio fueron 1104 las mujeres gestantes a las que se atiende su parto o cesárea. La mayor parte de las pacientes cursaban su primer embarazo 32 porciento siendo un porcentaje elevado (13). En relación a los antecedentes personales el 2.7 porciento corresponde a la hipertensión, la cual es una de las principales complicaciones que se encuentran con mayor frecuencia durante el embarazo. Loscmedicamentos consumidos durante el embarazo principalmente fueron amoxicilina, clotrimazol y cefalexina. No se obervaron malformaciones fetales en los recién nacidos. Finalmente durante el estudio se captaron dos muertes perinatales correspondientes a mujeres menores de 25 años una en el 2006 y otra 2007...

[Comparative efficacy of 10% sodium sulfacetamide lotion and 1% clotrimazole lotion in treatment of tinea versicolor]

Tinea versicolor is a common superficial fungal infection caused by normal skin flora and many topical and oral anti-fungal medications have been used for its treatment. The aim of this study was to compare the therapeutic effects of 10% sodium Sulfacetamide lotion with 1% Clotrimazole lotion in treatment of tinea versicolor. In this single-blind clinical trial 67 patients were divided into two groups using block randomization method. The first group consisted of 33 patients who were treated with 1% clotrimazole lotion. The second group included 34 patients who received 10% sodium sulfacetamide lotion. After 2 weeks of treatment, both groups were evaluated for clinical and paraclinical responses. The collected data were recorded in a data sheet and analyzed by X[2] and independent T tests, using SPSS software. After 2 weeks of treatment, clinical and paraclinical responses were seen in 22 patients [66.7%] and 28 patients [84.8%] in the first group [clotrimazole lotion] and in 7 [20.6%] and 8 [23.5%] patients of the second group [sodium sulfacetamide lotion], respectively. Statistical analysis showed that the differences are significant. The therapeutic effect of 10% sodium sulfacetamide lotion is much less than that of 1% clotrimazole lotion in treatment of tinea versicolor

Preparation and in vitro evaluation of liposomal/niosomal delivery systems for antifungal drug clotrimazole.

Clotrimazole, an imidazole derivative antifungal agent is widely used for the treatment of mycotic infections of the genitourinary tract. In order to develop alternative formulation for the vaginal administration of clotrimazole to provide sustained and controlled release of appropriate drug for local vaginal therapy, liposomes/niosomes were evaluated as delivery vehicles. To optimize the preparation of liposomes/niosomes with regards to size and entrapment efficiency, multilamellar liposomes/niosomes containing drug were prepared by lipid hydration method. The ability of the systems to deliver clotrimazole into and through the mucosa was evaluated in vitro using rabbit vaginal mucosa with vertical Franz diffusion cells. The in vitro permeation data showed that the liposomes/niosomes system increased the clotrimazole total penetration through the vaginal mucosa by 1.6, 1.5-fold, the accumulation of clotrimazole into the mucosa was increased by 3.1, 2.3-fold, respectively, as compared with control during 24 hr. These results suggest that the studied liposomes/niosomes systems may be appropriate vesicles for the vaginal mucosa delivery of clotrimazole for local vaginal therapy.

Candid-B cream in the treatment of candidiasis with inflammatory dermatoses--National Study Group.

Physicians (n = 84) across the country prescribed candid-B cream (clotrimazole 1% + beclomethasone dipropionate 0.025%) on 822 patients suffering from candidiasis with inflammatory diseases to evaluate the efficacy and safety of the combination. The results showed reduction in severity was more than 80% for all symptoms/signs except scaling and lichenification where the reduction was 76.05% and 66.03% respectively. Only one patient complained of adverse reaction. So in the treatment of coexisting candidiasis and inflammatory dermatoses the combination of clotrimazole 1% + beclomethasone 0.025% (candid-B cream) was found to be highly effective.

Vaginal Candidiasis: An incomprehensible Challege

A infecçäo recorrente da mucosa vaginal pela Candida albicans foi abordada realçando-se os mecanismos de interaçäo entre o fungo e o epitélio vaginal, com ênfase para os aspéctos imunológicos que controlam a proliferaçäo fúngica. Destaca-se o papel da imunidade celular mediada neste processo de eqüilibrio entre agente e hospedeiro, reforçando a importância via Th1, de resposta imune, onde há uma liberaçäo de citocinas como interferon-gama, interleucina-1 e 12. Por outro lado, a via Th2 que libera citocinas estimulantes da produçäo de anticorpos (interleucinas-4, 5 and 10) tera valor limitado na defesa da mucosa contra este agente. Comenta-se também o aspécto fisiopatogênico envolvendo resposta imune ligada aos processos alérgicos individuais e em decorrência de interaçäo como parceiro sexual. O diagnóstico principal "arma" para o tratamento adequado, é enfocado com ênfase na prática, reforçando-se o uso de bacterioscopias simples, sem esquecer que técnicas sofisticadas, como PCR, podem vir a ser útil para determinados casos. O tratamento da fase aguda e de manutençäo foi sugerido na tentativa de diminuir as recorrências, alertando-se principalmente para necessidade de tomar atitudes que visem näo somente o combate ao fungo, mas que também e fudamentalmente, priorize a identificaçäo e eliminaçäo de possíveis alérgenos

Estudo comparativo entre o oxiconazol em creme a 1% em aplicaçäo única diária e creme de clotrimazol a 1% em duas aplicaçöes diárias na tinea cruris e/ou corporis / A comparative study between oxiconazole cream, at 1% in a single daily dose and chlotrimazole cream at 1% applied twice-a-day in tinea coporis and or tinea crusis

Foi realizado estudo comparativo entre o uso de oxiconazol creme a 1%, em dose única diária, e clotrimazol creme a 1% em duas aplicaçöes diárias em dois grupos de 15 pacientes com tinea corporis e/ou cruris. Os pacientes foram avaliados clínica e micologicamente no pré-tratamento, na 1ª, 2ª e 4ª semanas após o início do tratamento. O trichophyton rubrum foi isolado em 66% de casos. Ao término do estudo pudemos verificar que näo só a resposta clínica e micológica bem como o resultado final de ambos os grupos näo diferiu estatisticamente. Houve cura em 100% dos pacientes. Os autores concluem que o oxiconazol creme apresenta as seguintes vantagens sobre o clotrimazol: um gasto duas vezes menor de medicamento e de tempo por parte do paciente na obtençäo de resultados clínicos e micológicoss semelhantes. O oxiconazol representa um avanço na terapia antimicótica por ser eficaz e seguro, apresentando como vantagem adional a comodidade de poder ser utilizado numa única aplicaçäo diária