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临床试验/CTRI/2017/11/010471
CTRI/2017/11/010471已完成2 期

Evaluation Of Effectiveness Of Combination Of Isotretinoin With Terbinafine And Terbinafine Alone In The Treatment Of Recurrent Dermatophytosis: A randomised Controlled Trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月30日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Cure rates of infection both clinically and microbiologiically in both the groups

研究概览

简要总结

Dermatophytosis is the fungal  infection of superficial  layers of the skin, hairs and nail. They are the most common infectious condition presenting to the skin out patient department. The incidence of recuurent and chronic infections are increasing now a days and many a factors are being attributed to this increase.  Few include drug resistance, bio film formation, changing environmental and working conditions, reinfection from other family members.  The most common species being identified from the lesions are also showing a changing trend from T. rubrum to other less commoner species. The incidence in india is some where around 20% of general population. Hence there is a need for exploration of alternate therapeutic agents in the treatment of this condition. recently a report was published in ijdvl, issue 5 about the use of oral isotretinoin in combination with itraconazole in the treatment of a single patient with recurrent dermatophytic infection and found to have complete cure in 4 weeks and no relapse was recorded in 6 months follow up. It was hypothesised that isotretinoin increased the epidermal turn over and lead to faster elimination of fungal spores from the skin, also tretinoin increased the skin pH and improved cell mediated immunity of the patient both of which were thought to help in the clearence of infection form the skin. hence, we plannned to conduct a study regarding the efficacy of isotretion in improving the clinical and microbiological cure rates in pateints with recurrent dermatophytosis. After careful selction of patients and after obtaining informed written consent,  they will be evaluated clinically, microbiologically and by laboratory investigatons. fungal cultures and bio film formation from the positive cultures will also be done. Then they will be randomised in to one of the two groups A and B by means of simple randomisation by computer generated random numbers and treated accordingly. group A with isotretinoin (0.5mg/kg) and terbinafine 250 mg twice daily for 4 weeks. group B with terbinafine250 mg twice daily for 4 weeks. no blinding will be done. post treatment they will be evaluated by means of clinical, microbiological and laboratory means. the side effects of the treatment will also be looked for. the patients will be followed up for a period of 3 months to look for the relapse of the disease. the proportion of cure rates and relapse rates will be assessed by means of proportion test and the results will be considered significant at 5 % level of significance.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients ≥ 18 years of age with tinea cruris and/or tinea corporis.
  • KOH (10%) positivity by microscopy from the lesion during the time of presentation.
  • Two or more episodes in one year.
  • Patients consenting to participate in the study.

排除标准

  • Not willing to consent and follow up for the study.
  • Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks.
  • Immunocompromised patients.
  • Patients with known active liver, cardiac, renal or neurological diseases or uncontrolled diabetes Mellitus.
  • Hypersensitivity to either isotretinoin or terbinafine.
  • Pregnant and lactating women.
  • Women desiring pregnancy.

结局指标

主要结局

Cure rates of infection both clinically and microbiologiically in both the groups

时间窗: After 4 weeks/ 6 weeks of treatment and after 3 months follow up

次要结局

  • 1) species identification(2) side effects of treatment)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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