NCT02693054已完成不适用
Characterizing Safety and Efficacy of Halo Hybrid Fractional Laser Treatments for Various Skin Conditions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sciton
- 入组人数
- 34
- 主要终点
- Improvement in skin conditions assessed by photographs
研究概览
简要总结
Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.
详细描述
The purpose of this study is to demonstrate safety and efficacy of Halo treatment as measured by changes in skin tone, texture and pigment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick Skin types I to IV
- •Desires improvement of significant skin conditions on the face and/or neck
- •Willingness to participate in the study by signing an informed consent form
- •Will have limited sun exposure for at least two weeks prior to study screening and during the study, including the follow-up period
- •Able to adhere to the treatment and follow-up schedule and post-treatment care instructions
- •Post-menopausal or surgically sterilized female subjects.
排除标准
- •History of Halo or resurfacing procedures in the treatment area within past six months
- •Has tanned within the past thirty days or unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray, or cream
- •Has tattoos, dysplastic nevi in the treatment area
- •Pregnant and/or lactating
- •Is planning to get pregnant within the study period
- •Has a known history of photosensitivity
- •Has used medication with photosensitizing properties within the past six months, e.g. isotretinoin
- •History or evidence of chronic or recurring skin disease or disorder (e.g. psoriasis, --Netherton syndrome, etc.) affecting the treatment area
- •Has open lacerations, abrasions, active cold sores, or herpes sores
- •Has hormonal disorders
- •History of keloid or hypertrophic scar formation or poor wound healing
- •History of immunosuppression or immune deficiency disorder (including HIV infection or AIDS) or use of immunosuppressive medications
- •History of bleeding disorder or taking anticoagulation medications
- •History of skin cancer or any other cancer in the treatment area
- •Has significant concurrent illnesses, such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
- •Has participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past thirty days
- •The investigator feels that for any reason the subject is not eligible to participate in the study
研究组 & 干预措施
Hybrid Fractional Laser Treatment
Experimental
Halo (1470nm and 2940 nm) laser
干预措施: HALO (Device)
结局指标
主要结局
Improvement in skin conditions assessed by photographs
时间窗: 6 months
Assessment of photographs by blinded evaluators
次要结局
- Subject satisfaction post final treatment(3 months)
研究者
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