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临床试验/NCT04956367
NCT04956367已完成3 期

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 Center2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
16
试验地点
2
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

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

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

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

研究点 (2)

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