A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Striae Texture
研究概览
简要总结
The primary objective of this study is to determine the effect of Stratacel® wound dressing on cosmetic outcomes following 1064/532nm picosecond laser (Picoway®, Syneron Candela Corp, Wayland, MA, USA) treatment of abdominal striae alba. Secondary objectives include examining the effect of Stratacel® wound dressing on post-laser healing and symptomatology.
详细描述
Twenty adult subjects with abdominal striae alba will be enrolled. All striae will be treated using the 1064/532nm picosecond laser with designated and standardized settings (Appendix A). The abdominal striae treatment region will then be split across the body vertically with one half randomized to Stratacel® and the other to placebo, clear ultrasound gel (Aquasonic). A blinded study coordinator will apply the products to each randomized half-abdomen immediately following laser treatment.
A total of 3 treatments will be completed at 1 month intervals. Blinded-investigator and subject self-assessments will be performed at post-treatment days 2, 5, 7, and 10 after each laser session. Assessments will also be performed 1 and 3 months after the final laser treatment.
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, Investigator)
盲法说明
Subjects are provided with de-identified tubes of both study product and vehicle then instructed on which de-identified product is to be used for aftercare on which side of the abdomen.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females or Males in good general health >18 years of age.
- •Must be willing to give and sign a photography release, HIPPA and informed consent.
- •Subject must have at least 2 white striae on each treatment side of the abdomen that measure at least 1cm in length.
- •Females will be either of non-childbearing potential defined as:
- •Having no uterus
- •No menses for at least 12 months.
- •Women of childbearing potential must agree to use an effective method of birth control during the course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation. Expectable forms of birth control below:
- •Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- •Intrauterine coil
- •Bilateral tubal ligation
- •Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- •Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
- •Vasectomized (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized partner).
排除标准
- •Pregnancy, planned pregnancy during the course of the study or currently breast feeding.
- •Projected significant fluctuations in weight during the course of the study or within the last 6 months, per investigator discretion.
- •Recent use of self-tanners, excessive exposure to sunlight, artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning and/or use of self-tanners during the course of the study.
- •Any planned surgical or cosmetic procedure in the treatment area during the course of the study.
- •Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- •Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- •Red or brown colored striae in the intended treatment area.
- •Active dermatitis, open wound, active bacterial, neurologic, fungal, or viral infection in the proposed treatment area.
- •Inability to ambulate following the procedure.
- •History of skin tightening or other treatment in the striae region in the preceding 12 months before study enrollment and for duration of the study.
- •Use of topical retinoids, hydroquinone, medicated cleansers, cellulite creams, or steroids to the treatment area within the preceding 2 weeks and for duration of the study.
- •Allergy to any ingredient in the study medication or placebo.
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
研究组 & 干预措施
Stratacel
medical grade silicone gel following Picoway Laser treatment
干预措施: Picoway (Device)
Stratacel
medical grade silicone gel following Picoway Laser treatment
干预措施: Stratacel (Other)
Vehicle
Clear ultrasound gel following Picoway Laser treatment
干预措施: Picoway (Device)
Vehicle
Clear ultrasound gel following Picoway Laser treatment
干预措施: Aquasonic (Other)
结局指标
主要结局
Change in Striae Texture
时间窗: Pre-Treatment to 3-months post final treatment.
Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale
Change in Striae Color
时间窗: Pre-Treatment to 3-months post final treatment.
Assessment of Color Pre treatment and post final treatment
Change in Striae Size
时间窗: Pre-Treatment to 3-months post final treatment.
Assessment of Size Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale.
Change in Striae Overall Appearance
时间窗: Pre-Treatment to 3-months post final treatment.
Assessment of Overall Appearance Pre treatment and post final treatment using a 6-Point Blinded Investigator Striae Assessment scale
次要结局
- Safety - Post Laser Treatment Adverse Events(days 2, 5, 7, and 10 after each laser session)
研究者
Isabella Guiha
CCRC
Goldman, Butterwick, Fitzpatrick and Groff