Subcision With Injection of Poly Deoxyribonucleotide Versus Subcision With Injection of Non-cross Linked Hyaluronic Acid in Rolling Acne Scars Treatment : A Split Face Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- changes in acne scar severity score
研究概览
简要总结
The aim of this study is to evaluate and compare the efficacy and safety of two different injectable agents combined with subcision for treating rolling acne scars. In this split-face clinical trial, each participant will receive subcision on both sides of the face. One side will then be treated with an injection of Polydeoxyribonucleotide (PDRN), while the other side will receive an injection of non-cross linked Hyaluronic acid (HA). The clinical outcomes and improvement in scar appearance will be assessed and compared between both treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Moderate to severe mainly rolling acne scars per validated scale (Goodman & Baron Grade 3-4)
- •Scars must be bilaterally distributed, allowing for split-face comparison
- •Stable acne (no active nodulocystic lesions, pustules, or recent outbreaks for ≥6 months)
- •No scar treatments (e.g., fillers, laser, microneedling) within the past 12 months
- •All skin types.
- •Both genders above 18 years old
排除标准
- •Systemic retinoid treatment within the last 6 months
- •Active inflammatory acne
- •Lidocaine sensitivity
- •Pregnancy and lactation
- •Severe systemic illness or malignancy
- •Use of anticoagulant or antiplatelet medications (unless cleared) Use of oral isotretinoin within the past 6 month
- •Herpes libialis, bacterial infection, other infections such as HBV, HCV or HIV
- •Tendency to keloid formation
- •Allergy to fish and salmon
研究组 & 干预措施
split-face treatment arm
Each participant will receive two different treatments: one side of the face will be treated with subcision followed by injection of polydeoxyribonucleotide, while the contralateral side will be treated wit subcision followed by injection of non-cross linked hyaluronic acid
干预措施: subcision with PDRN vs HA injection (Procedure)
结局指标
主要结局
changes in acne scar severity score
时间窗: Baseline and 3 months after last injection
Comparing both sides as regards: 1. Percent Change from baseline in Acne Scar Area, volume and maximum depth as assessed by anthera 3D image analysis at weeks 12 and 24 2. Mean change in Goodman \& Baron Quantitative Score for rolling acne scars from baseline to Weeks 12 and 24.
changes in acne scars severity score
时间窗: baseline and 3 months after final injection
Comparing both sides as regards: 1. Percent Change from baseline in Acne Scar Area, volume and maximum depth as assessed by anthera 3D image analysis at weeks 12 and 24 2. Mean change in Goodman \& Baron Quantitative Score for rolling acne scars from baseline to Weeks 12 and 24.
次要结局
未报告次要终点
研究者
Islam Abdelkareem Ismail Abujarbou
MSc Candidate in Dermatology
Cairo University