Efficacy and Safety of Ablative Fractional CO2 Laser and Platelet-rich Plasma (PRP) With Microneedling for Treatment of Acne Scars: a Real-world Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in Goodman and Baron Acne Scar Grading (Quantitative and Qualitative)
研究概览
简要总结
Road traffic accidents (RTAs) remain a major public health concern worldwide and in Bangladesh, contributing significantly to injury, disability, and premature death. In resource limited settings like Bangladesh, it is crucial to understand the factors that influence survival following an RTA in order to develop effective prevention strategies and improve patient outcomes. Therefore, this study aims to determine the 30 day survival rate and identify predictors of survival among adult RTA victims treated at a tertiary care hospital in Bangladesh. The observational study will be carried out at Emergency and casualty department of Dhaka Medical College Hospital (DMCH) between October 2025 and March 2026. A total of 204 adults (≥18 years) presenting to the hospital's Casualty Department with RTA related injuries will be included. Informed written consent will be obtained from each patient or their legal guardian prior to enrollment. Data will be collected through structured face to face interviews, review of hospital records, and follow up on the 30th day of accident. The follow-up will be conducted either in person or by telephone. Variables will include patient demographics, accident circumstances, admission characteristics, injury pattern and severity, pre-hospital care, clinical condition at admission, hospital management provided, and treatment outcome. All data will be analyzed using SPSS version 25.0. Kaplan-Meier analysis will estimate survival probabilities, while Cox proportional hazards regression will be used to identify independent predictors of mortality. The findings of this study are expected to generate context-specific, evidence-based insights for strengthening trauma care protocols, gap related to emergency handling of the RTA patients, enhancing pre-hospital emergency services, and informing policy decisions aimed at reducing preventable RTA-related mortality and morbidity in Bangladesh.
详细描述
Study Rationale:
Acne scars, notably atrophic scars, pose significant cosmetic and psychological concerns. Standard treatments include fractional lasers and microneedling-based interventions; however, rigorous comparative data in real-world clinical settings remain scarce. Recent evidence suggests ablative fractional CO2 laser and PRP-enhanced microneedling offer notable benefits. This split-face design allows direct comparison of efficacy, safety, and patient satisfaction between the modalities among Bangladeshi patients.
Study Design:
Type: Phase 3, open-label, randomized, split-face, comparative clinical trial
Planned Sample Size: 116 participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patients (age >18 years)
- •Both male and female sex
- •Patients with grade 2 to grade 4 acne scars, classified on the basis of Goodman's Qualitative classification.
- •Patient with equal Goodman's Qualitative scores on both halves of the face.
- •No active acne lesions.
- •Patients with atrophic scars only.
排除标准
- •Positive history of keloidal tendency.
- •Positive history of bleeding or platelet disorder.
- •Positive history of major surgery in past 6 months.
- •Presence of any acute infection on face like, herpes, folliculitis.
- •Patients of HIV, HBsAg, or any chronic illness.
- •Pregnancy
研究组 & 干预措施
Ablative fractional CO2 laser
Participants will receive ablative fractional CO₂ laser therapy on one side of the face using the SmartXide DOT Fractionated CO₂ Laser system. Treatment parameters include 15 W power, 800 µm spacing, 600 µs dwell time, and stack level 2. A total of three sessions will be administered, each one month apart.
干预措施: Ablative Fractional CO₂ Laser (Procedure)
Platelet-Rich Plasma (PRP) With Microneedling
Participants will receive intradermal injections of autologous PRP followed by microneedling on the opposite side of the face. PRP will be prepared using a double-spin centrifugation method from 8 mL of venous blood. Microneedling will be performed with a Dermapen (12-needle cartridge, 1.5 mm depth) until pinpoint bleeding is observed. A total of three sessions will be administered, each one month apart.
干预措施: Platelet-Rich Plasma (PRP) With Microneedling (Procedure)
结局指标
主要结局
Change in Goodman and Baron Acne Scar Grading (Quantitative and Qualitative)
时间窗: Day 30 (prior to Session 2), Day 60 (prior to Session 3), and at the final follow-up visit on Day 150
Improvement in acne scars will be assessed using the Goodman and Baron quantitative global acne scarring grading system and qualitative global acne scarring grading system.
次要结局
未报告次要终点
研究者
Azmiree Binte Aslam
Assistant Professor, Department of Dermatology and Venereology
Dr. Sirajul Islam Medical College