Comparative Study of Microneedling with Human Placental Extract vs Microneedling with Platelet-Rich Plasma for the Treatment of Stretch Marks (Striae Distensae)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in scar score (before and after treatment) and appearance
研究概览
简要总结
This is a split-face, non-randomised controlled , single center trial comparing the efficacy and safety of microneedling with Human Placental Extract versus microneedling with Platelet Rich Plasma (PRP) in 30 patients with striae distensae . The primary outcome will be change in scar score, measured at baseline, after each treatment session, and at the end of treatment (12 weeks). Secondary outcomes will include patient satisfaction (VAS) and global assessment score , both measured at baseline and final follow-up, along with the adverse effect profile recorded at every session and follow-up visit. This study will provide evidence regarding the relative effectiveness of these two modalities in improving the appearance of striae distensae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients of striae distensae who are 1) Age group between 18 and 40 years 2) Striae due to all the physiological causes- rapid weight gain/loss, pregnancy induced in non-pregnant women etc.
- •Striae alba.
排除标准
- •Patients between the age of
- •40 years of age 2) Striae due to bleeding disorders, autoimmune disorders , renal failure, chronic liver disease, any inflammation or wound , topical or systemic steroid use 3) History of keloid scarring 4)Pregnant and lactating women 5)Patient on blood thinners or immunosuppressants 6)Diabetic Patients.
结局指标
主要结局
Change in scar score (before and after treatment) and appearance
时间窗: Week 0 , Week 4 , Week 8 , Week 12
次要结局
- Patient satisfaction score / global assessment scale : Using a Visual Analogue Scale (VAS)
研究者
Dr Mansi Sunil Chavan
KLE Academy of Higher Education and Research , Deemed to be University , Belagavi