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临床试验/CTRI/2025/09/095502
CTRI/2025/09/095502尚未招募2 期

Effectiveness of antifungal cream containing two percent ketoconazole, zinc oxide, transcutol and lactic acid vs two percent ketoconazole in the management of treatment naive cutaneous superficial fungal infections A randomized open label control trial

Mridula T1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年10月13日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Overall clinical improvement, DSS score and reduction in pruritus, scaling and color in cutaneous superficial fungal infections

研究概览

简要总结

Superficial fungal infections are among the most common dermatoses in dermatology practice, primarily caused by dermatophytes, yeasts, and molds. Conventional topical antifungals such as azoles and allylamines are effective but are often limited by intolerance, resistance, and side effects. Ketoconazole, a widely used topical antifungal, acts by inhibiting ergosterol synthesis but is associated with irritation and other cutaneous adverse effects. To address these limitations, a novel topical formulation containing 2% ketoconazole combined with zinc oxide, transcutol, and lactic acid has been developed. This multi-component cream aims to enhance antifungal efficacy, reduce side effects, improve skin tolerance, and support barrier repair, thereby providing a cost-effective and well-tolerated treatment option for superficial fungal infections.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

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

入选标准

  • Consenting participants of age group 18- 65 years with clinically proven treatment naive cutaneous superficial dermatophytosis and tinea versicolor infections with symptoms for at least one week.

排除标准

  • Pregnant or lactating women
  • Participants with deep fungal infections or infections affecting the scalp, nails, or mucosal areas
  • Immunocompromised individuals
  • Known allergies or sensitivity to any ingredients in the study formulation
  • Unwilling to comply with study procedures.

结局指标

主要结局

Overall clinical improvement, DSS score and reduction in pruritus, scaling and color in cutaneous superficial fungal infections

时间窗: 0, 3 and 6 weeks

次要结局

  • Adverse effects, recurrence rates and patient satisfaction will be assessed(0, 3 and 6 weeks)

研究者

发起方
Mridula T
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mridula T

Saveetha medical college and hospital, Saveetha institute of medical and technical sciences

研究点 (1)

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