Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Stretch Mark Size
研究概览
简要总结
This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).
详细描述
Striae Distensae (SD) is a form of scarring that can oftentimes be quite disfiguring and emotionally distressing to individuals.
Fractional laser therapy has been used by doctors to treat stretch marks by stimulating collagen growth.
Poly-L lactic acid also promotes collagen growth in the areas injected.
The combination of laser and poly-L lactic acid might provide the optimal treatment modality for SD by decreasing the appearance of atrophic scars.
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
- Single (Outcomes Assessor)
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
- •Subject has bilateral striae alba
- •Subject has stable body weight for at least 6 months with Fitzpatrick skin type 1-4
排除标准
- •Subject has striae rubra
- •History of adverse effects to phototherapy
- •Subject has single sided lesions
- •Subject has immunosuppression
- •Subject has radiation therapy to the study area
- •Subject has topical or oral steroid use or chemotherapy within the last 6 months
- •History of keloids or hypertrophic scar
研究组 & 干预措施
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
干预措施: Poly-L Lactic Acid (Drug)
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
干预措施: Fractional laser treatment (Device)
Fractional laser treatment
One Fractional laser treatment on half of the body with Sciton Laser
干预措施: Fractional laser treatment (Device)
结局指标
主要结局
Change in Stretch Mark Size
时间窗: Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months
Modified Manchester Scar Scale was used to assess stretch mark reduction compared to pre-treatment photographs. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score.
次要结局
- Treatments Superiority Assessment(6 Months)
研究者
aamir siddiqui
Division Head - Plastic & Reconstruction Surgery
Henry Ford Health System