NCT05750901招募中不适用
Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sciton
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Wrinkles
研究概览
简要总结
Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 18-85 years
- •Fitzpatrick skin type I-VI
- •Has visible skin laxity in the treatment region or has a scar
- •Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study (Applicable to female subjects only)
- •Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
- •Subject must be able to read, understand and sign Informed Consent Form in English
- •Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions
排除标准
- •Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- •Any type of prior cosmetic treatment to the target area at physicians' discretion
- •History of malignant tumors in the target area.
- •Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
- •Pregnant and/or breastfeeding (Applicable to females only)
- •Having an infection, dermatitis or a rash in the treatment area.
- •Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
- •Suffering from coagulation disorders or taking prescription anticoagulation medications.
- •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •History of vitiligo, eczema, or psoriasis.
- •History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- •History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- •Current smoker or history of smoking within 6 months of study participation.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
研究组 & 干预措施
Treatment Arm
Other
Patients will receive fractional ablative treatment for laxity.
干预措施: Fractional ablative laser (Device)
结局指标
主要结局
Wrinkles
时间窗: 1-6 months post final treatment
Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.
次要结局
未报告次要终点
研究者
研究点 (2)
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