A Combined Subcision Approach With Either Fractional CO₂ Laser or Platelet-rich Plasma Versus Subcision Alone in the Treatment of Atrophic Post-acne Scars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Goodman and Baron quantitative acne scar score (Baseline vs 1 month post last session).
研究概览
简要总结
Acne vulgaris is an inflammatory disease of pilosebaceous unit ,leading to different types of scars including atrophic, hypertrophic and keloidal. Atrophic scars are the most common type ,affecting about 75-90% of acne scar cases and can be ice pick, rolling or boxcar in morphology . Theses scars may cause significant impact such as depression, anxiety , and reduced quality of life. multiple treatment modalities exist, including lasers ,chemical peels, dermabrasion, microneedling, subcision and platelet rich plasma. Subcision is a well established technique that improves rolling and boxcar scars by releasing fibrotic strands. Fractional co2 laser induces dermal remodeling and collagen neogenesis, while PRP enhances wound healing and collagen induction through growth factors. Combinig subcision with either co2 laser or PRP may enhance treatment efficacy compared to subcision alone.
rational : Subcision alone may provide limited improvement in some patients. Fractional CO₂ laser and PRP are promising adjunctive modalities that could enhance collagen remodeling and improve cosmetic outcomes. Evaluating their combined effect versus subcision alone will help determine the most effective and safe approach for managing atrophic post-acne scars.
aim of work:To compare the efficacy and safety of combined subcision with either fractional CO₂ laser or platelet-rich plasma versus subcision alone in the treatment of facial atrophic post-acne scars.
详细描述
Type of the study: Prospective, comparative, split-face study. - Study Setting: The study will be done in Assiut University Hospital ,dermatology department ,after obtaining approval from ethics committee of Faculty of Medicine, Assiut University in Assiut, Egypt.
Sample Size Calculation:
Based on determining the main outcome variable, the estimated minimum required sample size is 42 cases (21 in each group). Sample size was calculated using G*Power software version 3.1.9.7, based on the following assumptions: The main outcome is the difference in mean Goodman and Baron quantitative scar score between two independent groups of patients: those treated with Subcision + PRP and those treated with Subcision + Fractional CO₂.
Based on clinical experience and after reviewing the literature, a large difference was assumed.
The main statistical test is a one-tailed independent t-test to detect the difference between two means.
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 of both sexes with mild to severe atrophic post-acne scars.
排除标准
- •- Age < 18 years
- •Pregnant or lactating women
- •Active inflammatory acne or infection in treatment area
- •Premalignant or malignant lesions
- •Photosensitive dermatoses
- •Coagulation defects or blood disease
- •History of keloid scars
- •Systemic retinoid use in previous 6 months
研究组 & 干预措施
subcision alone
干预措施: subcision (Procedure)
subcision+fractional co2 laser
干预措施: subcision+fractional co2 laser (Procedure)
subcision+platelet rich plasma
干预措施: subcision+PRP (Biological)
结局指标
主要结局
Change in Goodman and Baron quantitative acne scar score (Baseline vs 1 month post last session).
时间窗: 3 sessions per patient at 1-month intervals Follow-up: 1 month after last session
If the scale was lowered by: (Quantitative) 0-5 points, the reduction will be considered minimal 5-10 points, it will be considered moderate reduction 10-15 points, it will be considered good reduction \>15 points, it will be considered very good reduction
次要结局
- Quartile grading scale improvement - Dermoscopic evaluation (erythema, pigmentation, photodamage, follicle density)(3 sessions per patient at 1-month intervals Follow-up: 1 month after last session)
研究者
Yasmeen Gamal Abdel Halim Ahmed
doctor
Assiut University