Assessment of Efficacy, Safety and Tolerability of Stratamark® (Innovative Self-drying Silicone Gel) in the Treatment and Prevention of Striae Distensae
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 272
- 主要终点
- Product efficacy in treatment of stretch marks
研究概览
简要总结
Stretch marks (striae distensae) are a form of scarring that is a natural result of pregnancy, obesity and in some instances occur due to puberty or steroid use. For some people, the stretch marks do not cause a problem, but in many circumstances they can cause physical symptoms such as itchiness, tenderness and pain. For many people stretch marks are also embarrassing and can have detrimental effects on a patient's mood and self-esteem. Stretch marks that result from pregnancy most commonly occur on the abdomen, breasts and thighs.
Topical silicone gel was developed nearly thirty years ago to be used in the treatment of widespread hypertrophic scars (abnormal scars, which may be red or raised/depressed itchy or painful). Since this time it has been used successfully on most scar types. . Since stretch marks are a form of scarring it is thought that topical silicone gel may be helpful for this scar type also. Stratamark™ has been developed using different forms of silicone polymers, in a gel format, that dries to form a very thin and flexible silicone gel sheet making it a convenient therapy for the treatment and prevention of stretch marks.
The aim of this clinical research study is to prove or disprove the efficacy, safety and tolerability of Stratamark™ in the prevention and treatment of stretch marks. In addition, the knowledge gained from this study may be of benefit to many future patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant woman (nulliparous or multiparous) entering into their third trimester (26-28 weeks, visit 1)
- •Not having striae on their abdomen at the time of trial enrollment
- •Prevention arm -
排除标准
- •Any significant medical or surgical conditions
- •Current medications liable to interfere with study results or change the skin's response to therapy
- •Treatment arm - Inclusion Critera:
- •Confirmed SD on their abdomen post-delivery
- •Treatment arm - Exclusion Criteria:
- •Any significant medical or surgical conditions
- •Current medications liable to interfere with study results or change the skin's response to therapy
研究组 & 干预措施
Prevention
干预措施: Stratamark® (Device)
Treatment
干预措施: Stratamark® (Device)
结局指标
主要结局
Product efficacy in treatment of stretch marks
时间窗: 6 months
Investigator-assessed improvement in stretch marks severity of patients treated with Stratamark from baseline to last assessment. Measurement tool: likert scale for stretch marks severity (0 to 6 - 0 being no stretch marks and 6 being severe).
Product efficacy in prevention of stretch marks
时间窗: 5 months
Investigator-assessed prevalence of stretch marks in the patients treated with Stratamark vs. a literature-based control group. Measurement tool: dichotomous scale for the occurrence of stretch marks (0 no stretch marks - 1 appearance of stretch marks).
次要结局
- Severity of stretch marks developed in prevention(5 months)
- Patient product evaluation in treatment of stretch marks(6 months)
- Patient evaluation of stretch marks in treatment(6 months)
- Patient product evaluation in prevention of stretch marks(5 months)
- Product efficacy in treatment of stretch marks(6 months)