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临床试验/CTRI/2024/06/069086
CTRI/2024/06/069086尚未招募4 期

Comparative efficacy and safety of Oral Tranexamic acid with 35 percent Glycolic acid peels and Oral Tranexamic acid with low Fluence Q Switched ND-YAG Laser in treatment of Melasma.

N Deekshitha1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
compare the efficacy of oral tranexamic acid with 35 percent glycolic acid peel and oral tranexamic acid with low fluence q switched nd-yag laser after 4 weeks and 12 weeks of post procedure

研究概览

简要总结

Melasma a chronic acquired hypermelanosis affecting mainly the face (malar regains,chin,forehead ,upper lips) mainly triggered by uv radiations ,hormones and by genetically influence ,in which  pathogenesis includes triggering of melanocytes, interaction between keratinocytes, mast cells, gene regulation abnormalities,neovascularization,disruption of basement membrane and hormones .Many treatment options are available with unsatisfactory results ,so combination methods like Oral tranexamic acid with 35 percent glycolic acids peels to randomly selected 100 patents with 2 weeks interval gap ,total 6 sessions for 3 months durations and oral tranexamic acid with low fluence q switched nd- yag laser to randomly selected 100 patients with 2 weeks interval gap ,total 6 sessions for 3 months duration.clinical examination for decreased pigmentation is done by using mMASI(Melasma area severity index) after the end of procedure.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant 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 people under age group 18 to 60 are included.

排除标准

  • Age less than 18 ,pregnancy, lactation, increased Bt,Ct, Pt-inr, using oral contraceptives pills ,pre existing inflammation dermatoses-atopic dermatitis ,systemic lupus ervthematosus, photo dermatoses, active infections, h/o contact dermatitis to glycolic acid products, thromboembolism, h/o intake of drugs with photosensitizing potential ,patients with keloid tendencies, patients with unrealistic expectations.

结局指标

主要结局

compare the efficacy of oral tranexamic acid with 35 percent glycolic acid peel and oral tranexamic acid with low fluence q switched nd-yag laser after 4 weeks and 12 weeks of post procedure

时间窗: After 4 weeks and 12 weeks of post procedure

次要结局

  • To find out the percentage of improved pigmentation in the lesions after 4 weeks & 12 weeks of post treatment .(Outcomes viewed after 4 weeks & 12 weeks post procedure)

研究者

发起方
N Deekshitha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr N Deekshitha

Esic medical college and hospital

研究点 (1)

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