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临床试验/NCT04697992
NCT04697992已完成不适用

Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation

研究概览

简要总结

Both vitamin C 20% and tranexamic acid 5mg/ml combined with microneedling were used for treatment of periorbital hyperpigmentation in a comparative pattern and both resulted in significant improvement of periorbital hyperpigmentation by dermoscopic and clinical evaluation with no statistically significant difference between them in addition to improvement of patients' visual analogue score (VAS) and dermatology life quality index (DLQI).

详细描述

Sixty patients with periorbital hyperpigmentation were enrolled, patients were divided into 2 groups; 30 each. clinical grading according to sheth et al.,2014 , dermoscopic evaluation, visual analogue score (VAS) and DLQI were done at week 0. Group A one side was treated with vit.c 20% + microneedling, other side saline+ microneedling (placebo). group B one side was treated with tranexamic acid 5mg/ml + microneedling, other side saline+ microneedling (placebo). A total of 4 sessions were done 2 weeks apart and follow up was one month after the last session (week 10) at which patient was evaluated using above mentioned parameters in addition to evaluation by 2 blinded investigators. At week 10 there was significant improvement of clinical grading and as evaluated by blinded investigators, VAS, DLQI, significant dermoscopic improvement in both vascular and pigmentary components of dark halos in sides treated with vit c and tranexamic acid compared to placebo but there was no statistically significant difference between both groups. The study concluded that tranexamic acid is a new safe effective modality in treatment of periorbital hyperpigmentation with results comparable to vitamin C.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

blinded investigators that assess grade of improvement at end of the study compared to baseline

入排标准

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

入选标准

  • both genders.
  • age ≥ 18 years.
  • pigmentary, vascular and mixed types of dark halos

排除标准

  • pregnancy and lactation
  • patients who received treatment in the past 3 months
  • patients with active dermatologic diseases or history of atopic dermatitis.
  • history of allergy to tranexamic acid or vitamin c
  • history of keloid or hypertrophic scars
  • pure structural type of dark halos, pigmentary demarcation lines

研究组 & 干预措施

group A

Experimental

one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).

干预措施: vitamin c 20% (Drug)

group B

Experimental

one eye was treated with tranexamic acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).

干预措施: Tranexamic acid 5mg/ml (Drug)

结局指标

主要结局

evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation

时间窗: 10 weeks (patients are assissed 1 month after the last session)

patient visual analogue score (score from 0 to 10 the higher the worst)

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Mohsen

Doaa Mohsen Fadl Morsy, Principal Investigator, teaching assistant at dermatology department

Kasr El Aini Hospital

研究点 (1)

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