Evaluation of the Efficacy and Safety of Oral Tranexamic Acid Combined With Glutathione-assisted Microneedling Versus Each Therapy Alone in the Treatment of Melasma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalities
研究概览
简要总结
In this study, the investigators evaluate the potential efficacy of TXA alone and microneedling assisted with glutathione alone versus combination of oral tranexamic acid and glutathione-assisted microneedling in the treatment of melasma
详细描述
Melasma is a chronic, acquired, frequent relapsing and cosmetically disfiguring disorder of hypermelanosis, characterized by light to dark brown hyperpigmentation mostly in sun exposed areas, affected predominantly middle aged females particularly those with darker skin, multiple factors have been postulated to involve in the etiology and pathogenesis of melasma like ; pregnancy, genetics, sun exposure and skin inflammation .Melasma significantly affect quality of life and self-steem of the patients due to its disfigurity appearance.
Although melasma has been widely studied, the treatment still met with difficulty, various therapeutic approaches were tried in treatment of melasma including topical and systemic treatments, chemical peeling, and laser therapy, however none have shown sustained results with incomplete clearance and frequent recurrences.
There has been interest lately in oral medications like tranexamic acid (TXA ) to improve melasma, oral TXA is a synthetic derivative of the amino acid lysine, lysine is an antifibrinolytic agent, procoagulant and approved by FDA for the treatment of cyclic heavy menstrual bleeding, oral TRX acid has been used off-label in dermatology for treatment of hyperpigmentation disorders
.
Also glutathione(GSH) is an option in treatment of melasma, GSH is endogenous tripeptide composed of cysteine, glycine, and glutamate, and serves as a key component of the cellular antioxidant defenCe system by scavenging free radicals and reducing oxidative stress it is considered as skin lightening agent, its major mechanism by inhibition of tyrosinase, tyrosinase inhibition effect indirectly as anti-oxidant agent.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •• female patients
- •18/50 years old
- •facial melasma
排除标准
- •pregnancy
- •lactation.
- •History of any bleeding,
- •clotting disorder
- •using anticoagulants
- •Chronic systemic diseases
- •patients with history of atypical parkinsonism
- •use of neuroleptics,
- •history of a seizure
- •drug addiction
- •Patients with signs of facial inflammation or infection.
- •Patients on oral contraceptive pills
- •patients with hormonal replacement therapy
- •patients on isotretinoin at the time of the study or during the past 6 months.
研究组 & 干预措施
Oral TXA
will include 14 patients, they will be treated by
- oral TXA alone 250mg twice daily for a maximum of 3 months.
干预措施: Oral tranexamic acid (Drug)
Combined TXA + GSH-assisted microneedling arm
will include 14 patients with facial melasma. They will be treated by combined
- oral tranexamic acid (250 mg) twice a day for 3 months
- microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.
干预措施: microneedling (Device)
Combined TXA + GSH-assisted microneedling arm
will include 14 patients with facial melasma. They will be treated by combined
- oral tranexamic acid (250 mg) twice a day for 3 months
- microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.
干预措施: Oral tranexamic acid (Drug)
Combined TXA + GSH-assisted microneedling arm
will include 14 patients with facial melasma. They will be treated by combined
- oral tranexamic acid (250 mg) twice a day for 3 months
- microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.
干预措施: Glutathione (Other)
GSH-assisted microneedling arm
will include 14 patients, they will be treated by microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.
干预措施: microneedling (Device)
GSH-assisted microneedling arm
will include 14 patients, they will be treated by microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.
干预措施: Glutathione (Other)
结局指标
主要结局
compare reduction of Melasma Area and Severity Index (MASI) score in any treatment modalities
时间窗: From baseline to 12 weeks
次要结局
- identify patient's satisfaction by Patient Self Assessment(from baseline to 3 months after treatment)
研究者
Rana Sameer Mohamed
Assistant lecturer
Assiut University
