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临床试验/NCT07448415
NCT07448415尚未招募2 期

Evaluation of the Efficacy and Safety of Oral Tranexamic Acid Combined With Glutathione-assisted Microneedling Versus Each Therapy Alone in the Treatment of Melasma

Assiut University0 个研究点目标入组 42 人开始时间: 2026年2月1日最近更新:
干预措施

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

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

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

Rana Sameer Mohamed

Assistant lecturer

Assiut University

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