Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study
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
- 否
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
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
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
Doaa Mohsen
Doaa Mohsen Fadl Morsy, Principal Investigator, teaching assistant at dermatology department
Kasr El Aini Hospital
