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临床试验/NCT07522788
NCT07522788尚未招募4 期

Comparison Between Efficacy of Topical Tranexamic Acid Vs Topical Ethyl Ascorbic Acid In Treatment Of Melasma

Hayatabad Medical Complex0 个研究点目标入组 128 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
128
主要终点
Assessment of Melasma Area Index Score

研究概览

简要总结

This study is to compare the efficacy of topical tranexamic acid vs topical ethyl ascorbic acid in the treatment of melasma

详细描述

Comparison Between the Efficacy of Topical Tranexamic Acid VS Topical Ethyl Ascorbic Acid in the Treatment of Melasma Introduction Melasma is a prevalent acquired condition marked by brownish to grayish patches of discoloration on sun-exposed areas of the face, predominantly affecting women. While the precise cause of melasma remains unclear, it is thought to be multifactorial, involving the interplay of genetic, hormonal, and environmental factors, along with other risk elements.1 According to reports the prevalence of melasma in Pakistan is 46%, which is quite high. 2 The etiology of melasma is complex, involving multiple factors such as genetics, UV exposure, pregnancy, and the use of hormonal contraceptives.3 Melasma treatment is challenging due to its unclear etiology, refractory nature, and frequent relapse. Current therapies are divided into non energy-dependent (e.g., hydroquinone, alpha arbutin, azelic Acid, retinoids, Vit C , chemical peels( glycolic acid, lactic acid, salicylic acid)and energy-dependent (e.g., lasers, intense pulsed light) categories.3,4 Topical tranexamic acid (TXA) and ascorbic acid are both effective in treating melasma, with outcomes varying by skin type and treatment combination. TXA demonstrates versatility, particularly when combined with lasers or hydroquinone, yielding significant pigmentation improvements. Ascorbic acid, especially with microneedling, shows notable efficacy in skin type III and outperforms TXA in specific cases. Both agents are valuable, with tailored approaches enhancing their effectiveness. (4-7) Muhammad Fahim et al. compared the effectiveness of intradermal tranexamic acid (TXA) and topical magnesium ascorbyl phosphate (MAP) in treating melasma. The study included 128 patients, divided into two groups of 64 each. Group A received intradermal TXA injections, while Group B used topical MAP cream. After 12 weeks, the study found that the efficacy of TXA was 54.7%, while MAP showed a higher efficacy of 78.1%. The study concluded that topical MAP is more effective than intradermal TXA for treating melasma .2 The rationale of this study is to compare the efficacy with topical TXA versus topical Ethyl Ascorbic Acid (EAA ) for Melasma in terms of reduction in MASI scores. Melasma treatment often involves trial and error due to variability in patient response and recurrence rates. While both TXA and EAA are widely used, comparative data on their efficacy and safety profiles in similar clinical scenarios is scarce. This study seeks to address this gap, providing insights to guide clinicians in choosing the most effective and patient-friendly option.

Objective:

To compare the efficacy of topical TXA versus topical EAA for Melasma in terms of reduction in mean MASI scores.

Operational Definition:

Melasma: It is defined as a skin condition characterised by brownish to greyish discoloration on skin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age 18 to 50 years Clinically diagnosed Melasma Irrespective of gender and ethnicity

排除标准

  • pregnant and lactating women Patients with a history of skin allergies to study medications Use of systemic steroides or anti coagulants within the last month Patients on other melasma treatments for atleast 4 weeks prior

研究组 & 干预措施

ethyl ascorbic acid Group

Active Comparator

The participants in this arm will receive only topical ethyl ascorbic acid

干预措施: Ethyl ascorbic acid topical application (Drug)

ethyl ascorbic acid Group

Active Comparator

The participants in this arm will receive only topical ethyl ascorbic acid

干预措施: Tranxemic acid topical application (Drug)

Topical tranexamic acid group

Active Comparator

Participants in this group will receive only topical tranexamic acid

干预措施: Ethyl ascorbic acid topical application (Drug)

Topical tranexamic acid group

Active Comparator

Participants in this group will receive only topical tranexamic acid

干预措施: Tranxemic acid topical application (Drug)

结局指标

主要结局

Assessment of Melasma Area Index Score

时间窗: 6 months

We will assist the improvement in hyperpigmented patches of melasma based on MASI

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Naheed asghar

Associate professor Dermatology unit HMC

Hayatabad Medical Complex

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