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临床试验/CTRI/2025/12/098427
CTRI/2025/12/098427尚未招募不适用

Efficacy of topical isobutylamido thiazolyl resorcinol (thiamidol) compared to triple combination therapy in patients with melasma a prospective study

Dr Bandreddy Peranti1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年1月2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
68
试验地点
1
主要终点
Efficacy of topical Thiamidol compared to triple combination therapy in patients with Melasma. Reduction in mMASI score indicating improvement in melasma severity

研究概览

简要总结

The trial has not begun enrolling patients

Melasma is a pigmentary disorder that affects middle aged women more commonly presents as hyperpigmented irregular macules patches on sun exposed areas like cheeks upper lip chin  nasal bridge forehead and the neck

It is a stubborn condition which is more prone to relapse  It has a complex etiology like exposure to Ultraviolet radiations pregnancy oral contraceptive pills Hormone replacement therapy etc

Various studies used multiple treatment modalities including topically applied depigmenting agents like hydroquinone alone triple combination therapy cysteamine chemical peels glycolic acid and laser therapy with none of them showing satisfactory outcomes

Thiamidol is now being identified as a new potent inhibitor of human tyrosinase enzyme

This  study titled Efficacy of Topical Isobutylamido Thiazolyl Resorcinol Thiamidol Compared to Triple Combination Therapy in patients with Melasma  over 18 months The study aims to compare the therapeutic efficacy and safety of topical Thiamidol with the conventional triple combination therapy in patients with melasma

A total of 68 patients clinically diagnosed with melasma will be randomly divided into two groups Group A  will be treated with topical Thiamidol Group B will be treated with triple combination therapy

Clinical assessment will be done by using the Modified Melasma Area and Severity Index mMASI at baseline 4 weeks 8 weeks and 12 weeks Clinical photographs will be taken at each time point under standardized conditions Data will be analyzed using paired and unpaired t tests

The primary outcome will be the change in mMASI score from baseline to 12 weeks which will indicate treatment efficacy The secondary outcomes will include the evaluation of side effects and patient tolerance to each therapy

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

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 females and males with Melasma aged above18 years Patients who are not on any other treatment for Melasma for past 1 month and patients who are advised to stop treatment for 1month Patients unresponsive to regular topical agents.

排除标准

  • Allergy or sensitivity to Thiamidol Active skin conditions or infections like eczema, dermatitis in the treatment area Recent laser or light based therapies Pregnancy and lactation.

结局指标

主要结局

Efficacy of topical Thiamidol compared to triple combination therapy in patients with Melasma. Reduction in mMASI score indicating improvement in melasma severity

时间窗: Clinical assessment was performed using the Modified Melasma Area and Severity Index mMASI at baseline 4 weeks 8 weeks and 12 weeks

次要结局

  • The secondary outcomes included the evaluation of side effects and patient tolerance to each therapy

研究者

发起方
Dr Bandreddy Peranti
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Bandreddy Peranti

Alluri Sitarama Raju Academy of Medical Sciences

研究点 (1)

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