Efficacy of Ablative Fractional Carbon Dioxide Laser Combined With Autologous Platelet-rich Plasma Versus Ablative Fractional Carbon Dioxide Laser and Placebo in the Treatment of Striae Gravidarum: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
This study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum Filipino women.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Used a computer-generated software to randomize the area to be treated.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum patients with ages 18 to 45 years
- •Fitzpatrick skin type III-V
- •having bilateral symmetrical SG of red, white or a combination of both types.
排除标准
- •pregnancy
- •breastfeeding
- •heavy consumption of alcoholic beverages
- •dermatological conditions such as psoriasis, systemic lupus erythematosus and atopic dermatitis
- •uncontrolled hypertension, diabetes mellitus, heart disease, acute and chronic liver/kidney impairment/disease;
- •elevated liver function tests (SGPT, SGOT), and serum creatinine;
- •intake of any medications that may influence the outcome of the study;
- •intake of any vitamins/minerals or any supplements in the past 6 months; and
- •application of any topical agents (e.g., whitening, anti-aging) in the past 6 months
研究组 & 干预措施
CO2 laser with placebo
After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, pNSS will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals.
干预措施: CO2 laser with placebo (Device)
CO2 laser with PRP
After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, PRP will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals.
干预措施: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma (Procedure)
CO2 laser with PRP
After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, PRP will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals.
干预措施: CO2 laser with PRP (Device)
CO2 laser with placebo
After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, pNSS will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals.
干预措施: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma (Procedure)
结局指标
主要结局
Clinical improvement
时间窗: 16 weeks
Change in appearance based from clinical photos done in baseline, week 6, week 10, week 14 and week 16 . This will be assessed by quartile grading scale (poor, \<25% improvement; fair, 25-50% improvement; good, 51-75% improvement; and excellent, \>75% improvement)
次要结局
- Patient satisfaction rate(16 weeks)
研究者
Ivan Arni Preclaro
Efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser and placebo in the treatment of striae gravidarum: a randomized clinical trial
Jose R. Reyes Memorial Medical Center