NCT06469398进行中（未招募）不适用
A Post Market Study of a Laser System for the Treatment of Acne Vulgaris
Cutera Inc.6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Percent of Subjects Who are Responders
研究概览
简要总结
To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne vulgaris.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or Male, Fitzpatrick Skin Types I-VI, 16 to 60 years of age (inclusive).
- •Has clinically diagnosed acne vulgaris of severity grade 3 - 4 (moderate to severe) on the face based on photographic review by expert dermatologist grader(s) using the Investigator's Global Assessment Scale.
- •Has ≥ 10 inflammatory acne lesions on the face as determined by the Investigator (or qualified designee).
- •Subject (and parent or legal guardian if subject is a minor under age 18) must be able to read, speak, and understand English and sign the Informed Consent Form.
- •Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
- •Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an investigator approved sunblock or sunscreen of SPF 30 or higher on the face every day for the duration of the study, including the follow-up period.
- •Must maintain the same acne treatment regimen, including topical and systemic medications for at least 2 weeks prior to enrollment, and for the duration of the study, including the follow-up period unless approved by the Investigator.
- •Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes.
- •Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study unless approved by Investigator.
- •Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.
排除标准
- •Has clinically diagnosed acne vulgaris of severity grade 0, 1, 2 (clear, almost clear, mild) on the face based on photographic review by expert dermatologist grader(s) using the Investigator's Global Assessment Scale.
- •Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation.
- •Still healing from another treatment in the target area according to investigator's discretion.
- •Currently pregnant or planning on becoming pregnant anytime during the duration of the study.
- •Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that may preclude treatments, photos, or accurate acne lesion assessments in the target area.
- •Currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer.
- •As per the Investigator's discretion, any physical, mental or medical condition which might make it unsafe for the subject to participate in this study or might interfere with patient's participation in the full study protocol.
- •Known hypersensitivity to, history of allergic reaction to, or contraindication to Pro-Nox or mild oral anti-anxiety or pain medication, if administered.
结局指标
主要结局
Percent of Subjects Who are Responders
时间窗: 12 weeks post final treatment
The primary outcome measure to evaluate the efficacy of the Cutera device is the percent of subjects who are responders at 12 weeks post final treatment, where a responder is defined as ≥ 1-point reduction on the Investigator's Global Assessment scale at follow up compared to baseline.
次要结局
未报告次要终点
研究者
研究点 (6)
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