A split face Comparative Interventional study to evaluate efficacy of Microneedling Radiofrequency versus Microneedling Radiofrequency combined with Topical Insulin in management of post acne atrophic scars
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in scar score and appearance after treatment
研究概览
简要总结
This is a split-face, non-randomised controlled, single centre trial in 40 patients comparing the efficacy and safety of microneedling radiofrequency with topical insulin versus microneedling radiofrequency in the treatment of post acne atrophic scars. 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/GAIS) and investigator’s global assessment, 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 post acne atrophic scars.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Presence of atrophic acne scars on both sides of the face 2.Age between 18 and 45 years, 3.Absence of post-acne scar treatment in the previous three months.
排除标准
- •1.Presence of active acne lesions.
- •2.Patients having keloid scarring or keloidal tendency.
- •3.History of bleeding disorder and anticoagulant therapy.
- •4.Oral steroid therapy.
- •5.Active localised skin infection like warts, herpes and bacterial infection.
- •6.Pregnancy and lactation 7.Uncontrolled blood glucose levels and history of diabetes mellitus 8.prior laser treatment for acne scars within the last 3 months, 9.allergy to insulin 10.Patients refusing to give consent for the study.
结局指标
主要结局
Change in scar score and appearance after treatment
时间窗: baseline (week 0), week 4, week 8, week 12
次要结局
- 1. Patient satisfaction score by Visual Analogue scale(2.Statistical significance of improvement (microneedling radiofrequency with topical insulin vs microneedling radiofrequency))
研究者
Dr Jaseeba Gurpreet Dhingra
KLE Academy of Higher Education and Research Deemed to be University, Belagavi