Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid in Combination With Topical Hydroquinone for Refractory Melasma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Refractory Melasma Treatment combination with topical hydroquinone
研究概览
简要总结
Melasma is a common acquired disorder of hyperpigmentaion caused by increased melanin production by melanocytes.
Melasma is a name derived from the Greek word melas meaning black.It is characterized by the appearance of brownish or grayish symmetrical patches on sun-exposed skin, most commonly on the face. Compared to men, women are more likely to be affected.
详细描述
Melasma is more common in people with dark complexions and Fitzpatrick skin types III IV.Depending on ethnicity and region, melasma prevalence might vary from 8.8% to 40%. The cause of melasma is still unknown in the meantime.
Numerous elements, including genetics, sunshine, endocrine stimulation, oxidative conditions,pregnancy, exogenous hormons,and morphofunctional changes, may have a role in the development of the disease.
Since melasma is a common skin condition affecting mostly pregnant women and those on hormonal birth control, it is known as the "mask of pregnancy,
Treatment for melasma remains a challenge, with substantial psychosocial ramifications. Many factors, including variability in clinical presentation and responsiveness to treatment between genders, skin phototypes, and ethnicities, can affect treatment efficacy. None of variety methods have been sufficiently effective to be considered the gold standard.
Hydroquinone (HQ) has historically been the most studied topical agent in the treatment of melasma. HQ is a hydroxyphenolic compound that inhibits the conversion of dopa to melanin by the inhibition of tyrosinase; it also inhibits RNA and DNA synthesis of melanocytes and degrades melanosomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes with melasma.
排除标准
- •Pregnancy
- •Lactation
- •Administration of oral contraceptive pills or any phototoxic drug within 1 month prior to study
- •Patients with a history of thrombosis, abnormal bleeding profile, known hypersensitivity to TA or HQ, and endocrinal disease.
研究组 & 干预措施
Group A
About 15 cases will receive sessions with fractional Er: YAG laser every 3 weeks followed by application of topical 4% (HQ) cream.
干预措施: Tranexamic acid injection (Drug)
Group B
About 15 cases will receive sessions of intradermal injection of tranexamic acid on the melasma site every 3 weeks concurrently with the application of topical 4% HQ cream every night. The injections will be done using an insulin syringe with a dilution of the tranexamic acid
干预措施: Tranexamic acid injection (Drug)
Group C
About 15 cases will receive oral tranexamic acid 500mg tablet once daily for three months. And will also be asked to apply a thin layer of topical HQ 4% cream on the hyperpigmented areas once every night.
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
Refractory Melasma Treatment combination with topical hydroquinone
时间窗: 3 months
to detect the treatment response by YAG laser vs intradermal and systemic tranexamic acid by using The MASI index ( MASI is an index designed to quantify the severity of melasma during therapy).
次要结局
未报告次要终点