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临床试验/CTRI/2024/07/071678
CTRI/2024/07/071678尚未招募不适用

Safety and efficacy of oral itraconazole versus oral itraconazole with isotretinoin in chronic and recurrent superficial dermatophytosis A randomized trial

Bhagat Phool Singh Govt. Medical College1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Clinical assessment score, Global assessment index

研究概览

简要总结

Dermatophytosis is a superficial cutaneous fungal infection of the keratinized tissues of skin, hair and nails. These infections are very common in India where hot and humid climate in association with poor hygienic conditions play an important role in the growth of these fungi. In the past few years, the chronicity, severity, clinical presentation, relapse rates and resistance to treatment patterns have significantly altered in India.  Various factors such as host, agent, pharmacologic or environmental may be responsible for these alterations. Chronic dermatophytosis is defined as illness that lasts for more than 6 months to 1 year, with or without recurrence, irrespective of the treatment. Recurrent dermatophytosis applies to the re-occurrence of the fungal infection within a few weeks of completion of treatment.  Antifungal drugs like itraconazole, griseofulvin, terbinafine are no longer giving satisfactory results. Such infections are a cause of significant distress to patients socially, financially, and emotionally. In few studies combination of itraconazole and isotretinoin was successfully treated chronic dermatophytosis. It was proposed that retinoids cause desquamation and decrease the fungal colonies from stratum corneum. However there is paucity of literature comparing efficacy of itraconazole versus isotretinoin with itraconazole. In this study, we will evaluate comparative efficacy and safety of oral itraconazole versus oral itraconazole with isotretinoin in chronic and recurrent dermatophytosis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All adult patients in the age group of 18 to 60 years who are clinically diagnosed with tinea corporis and cruris with more than 20% BSA and duration of infection is more than 6 months with KOH positive preparation attending the dermatology Out Patient Department of BPS GMC(W) Khanpur Kalan, Sonepat.

排除标准

  • Patients with tinea capitis and onychomycosis.
  • Patients with tinea for less than 6 months or limited tinea involving less than 20% of body surface area.
  • Any patient who took itraconazole for tinea in last one year.
  • Patients with liver diseases, renal diseases and ischaemic heart diseases.
  • Patients with hyperlipidaemia.
  • Patients currently on immunosuppressive and corticosteroid therapy.
  • Pregnant and lactating women and females of reproductive age who cannot or refused to take contraceptive pills.

结局指标

主要结局

Clinical assessment score, Global assessment index

时间窗: Baseline, 2 & 4weeks

次要结局

  • KOH examination, CBC, LFT, lipid profile, urine pregnancy test(Baseline, 2 & 4weeks)

研究者

发起方
Bhagat Phool Singh Govt. Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Usha Chhillar

BPS Govt. Medical College for Women

研究点 (1)

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