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临床试验/CTRI/2025/11/096824
CTRI/2025/11/096824尚未招募2/3 期

EFFECT OF ADDING LULICONAZOLE 1% CREAM TO SYSTEMIC ANTIFUNGAL FOR GLABROUS TINEA

未提供1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年11月13日

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
112
试验地点
1
主要终点
To evaluate cure rates with Luliconazole 1%cream and systemic antifungal drug, versus only systemic antifungal drug in patients of glabrous tinea.

研究概览

简要总结

Written informed consent will be taken in Hindi or English, as per the patient’s choice. 2. Diagnosis will be made clinically and confirmed by direct microscopic examination using 10% potassium hydroxide (KOH)mount performed in clinic. 3. Recording of lesions and BSA estimation will be done and clinical photographs will be taken. 4. Patients will be asked to score their pruritus on a Numeric Rating Scale(NRS) from 0(minimum) to 10(maximum). 5. A detailed history of disease onset , duration, course, family history, and previous treatments will be recorded. Systemic antihistaminic drugs will be given to both the groups for pruritus. 7. The included patients shall be randomized to one of the two groups by a computer generated randomization chart. Patients will be given Lulicoanzole 1%cream along with T. Terbinafine 250mg BD and only T. Terbinafine 250mg BD on the basis of Randomisation chart. 8. Clinical assessment at baseline and follow ups will be performed 2 weekly.. 9. This will include recording clinical clearance(as percentage improvement), NRS score and any adverse effects , and a KOH examination from remaining lesions. 10. The end point of treatment in each recruited patient would be a complete cure or failure. 11. Relapse rates will be assessed after 12 weeks of complete cure.12. Decoding of treatment groups would be done on trial completion

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

  • Extent of disease involving less than 10 percentage of body surface area.
  • Those with positive KOH at first assessment.
  • Those who have not taken any systemic antifungal in preceeding 4weeks and any topical antifungal or topical steroid in preceeding 2weeks.
  • willing to be part of trial.

排除标准

  • Pregnant and lactating females.
  • Those recieving systemic drugs with major pharmacokinetic interactions with Terbinafine.
  • Patients with systemic comorbidities.

结局指标

主要结局

To evaluate cure rates with Luliconazole 1%cream and systemic antifungal drug, versus only systemic antifungal drug in patients of glabrous tinea.

时间窗: To evaluate cure rates with Luliconazole 1%cream and systemic antifungal drug, versus only systemic antifungal drug in patients of glabrous tinea.

次要结局

  • To evaluate cost effectiveness of treatment of both groups.(To evaluate the duration of treatment of both groups.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

DR SHARDA LONGANI

RML hospital

研究点 (1)

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