Comparative Study for Facial Scar Remodeling Using Fractional Carbon Dioxide Laser Combined With Polydeoxyribonucleotide (PDRN) Versus Fractional CO₂ Laser: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Vancouver Scar Scale
研究概览
简要总结
Facial scars are frequently deemed unpleasant and can profoundly impact a patient's psychological health. This study compares the effectiveness, safety, and capacity to speed up scar healing in the maxillofacial region between fractional carbon dioxide (CO₂) laser therapy alone and polydeoxyribonucleotide (PDRN) combined with CO₂ laser therapy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Limitations: Participants must be between 18 and 50 years of age.
- •Recently cut wounds or surgical scars from about (1-6 months).
- •Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.
排除标准
- •Pregnancy or breastfeeding at the time of study.
- •Known allergy to PDRN.
- •Medication use that could affect wound healing or inflammation, such as:
- •Isotretinoin.
- •Anticancer drugs.
- •High-dose corticosteroids.
- •Anticoagulants.
- •Uncontrolled medical diseases (e.g., unstable diabetes, cardiac conditions).
研究组 & 干预措施
Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN)
includes patients who will be enrolled for PDRN injection into the surgical scar
干预措施: Polydeoxyribonucleotide (Drug)
Fractional Carbon Dioxide Laser Combined with Polydeoxyribonucleotide (PDRN)
includes patients who will be enrolled for PDRN injection into the surgical scar
干预措施: Fractional CO2 laser assisted PDT (Device)
Fractional CO₂ laser therapy with placebo saline injection
includes patients who will be enrolled for placebo saline injection into the surgical scar
干预措施: Fractional CO2 laser assisted PDT (Device)
结局指标
主要结局
Vancouver Scar Scale
时间窗: 4 months
The study used the standard Vancouver Scar Scale, which evaluates four characteristics of scars: Total Score Range: 0 (normal skin) to 13 (severe hypertrophic scar)
次要结局
未报告次要终点
研究者
Omnia Tarek Hosni
Demonstrator in Oral & Maxillofacial Surgery Department, MUST
Misr University for Science and Technology