NCT02050126已完成不适用
Caesarean Scar Revision With the UltraPulse
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Scar Evaluation
研究概览
简要总结
Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted in 1 site.
Each subject will receive three treatments on one area that was randomly chosen. The other area will be left untreated and will serve as a control.
The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated scar side.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females in good general health older than 22 years of age and younger than 55 years of age.
- •Presenting with a caesarean scar mature and stable caesarean scar (at least 1 year post procedure).
- •At least six months following termination of breast feeding.
- •Willing to give and sign an informed consent form and a photographic release form.
- •Willing to comply with study dosing and complete the entire course of the study .
- •Performed negative pregnancy test.
排除标准
- •Active bacterial, fungal, or viral infection in the treatment area.
- •Active cold sores, or herpes in the treatment area.
- •Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study .
- •History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
- •Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics).
- •History or presenting with a keloid scar.
- •Any current or recent treatment for cancer.
- •Any uncontrolled systemic disease. A potential subject 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.
- •Previous laser treatments on the same scar at least 0.5 year prior to this evaluation.
- •Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator .
- •Any other condition that may exclude patient for treatment per physician discretion.
- •Female subject who is pregnant, nursing an infant .
结局指标
主要结局
Scar Evaluation
时间窗: 3 month following the 3rd treatment.
VSS , POSAS, Appearance assessment-Evaluation of the scar by blinded investigator.
次要结局
- Scar Evaluation.(At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up)
- POSAS assessment(At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up)
- Scar Thickness and Uniformity(At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up)
- Scar color(At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up.)
- Histochemical Changes in scar tissue(Immediately before the 2nd, and 3rd treatment)
- Subject's satisfaction(At the 3rd treatment and at the 1, 3 and 6 month follow-up)
研究者
研究点 (2)
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