Efficacy of topical isobutylamido thiazolyl resorcinol (thiamidol) compared to triple combination therapy in patients with melasma a prospective study
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
Dr Bandreddy Peranti
Alluri Sitarama Raju Academy of Medical Sciences
