Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for the Treatment of Mild to Moderate Inflammatory Acne.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acne lession count
研究概览
简要总结
This is a clinical research study to determine the ability of the Clear device to treat mild to moderate inflammatory acne, and to determine if the average person is able to use the device properly according to the labeling as describe in the operator manual.
The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in which the subjects will be treating themselves with the Clear device, and 2 follow-up visits to evaluate the results. The clinical result will be assessed by the investigator for improvement in the acne condition. Treatment will be performed on the face of subjects enrolled and who meet the inclusion criteria.
详细描述
The subjects will be recruited if they are eligible to participate in the study according with the device labeling presented at the doctor's office by printed ads. Subjects will be given information about the Clear device according to its labeling. After reading the information and labeling, it will be the subjects' decision if they understand the device label information and if they want to participate in the study. The investigator will review the inclusion / exclusion criteria with the subjects to ensure eligibility.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of mild to moderate acne.
- •Skin Type I to VI (Fitzpatrick).
- •Males or females who are 21-65 years old.
- •Willingness to follow the treatment schedule, post-treatment care and have photographs taken.
排除标准
- •Pacemaker or internal defibrillator.
- •Permanent implant in the treated area, such as metal plates and screws or silicon, unless deep enough in the bone.
- •Skin areas that have been injected with Botox/ Hyaluronic acid /collagen/fat injections or other augmentation methods with bio-material during last 6 months.
- •Current or history of skin cancer, or any other type of cancer, or pre-malignant moles.
- •Current severe medical conditions, such as heart and lung disorders.
- •Pregnant or breastfeeding.
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- •History of diseases stimulated by heat, such as recurrent Herpes Simplex (cold sores) in the treatment area, unless treated by following a preventive regime.
- •Poorly controlled endocrine disorders, such as diabetes or thyroid disorders.
- •Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosacea.
- •History of skin disorders, keloids (excessive scarring), abnormal wound healing, as well as very dry and fragile skin.
- •History of bleeding disorders, or use of anticoagulants in the last 10 days.
- •Any facial surgery performed within 12 months prior to treatment.
- •Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
- •Received treatment with light, laser, radiofrequency (RF), or other devices in the treated area within 6 months.
- •Used isotretinoin (Accutane®) within 6 months prior to treatment.
- •Using of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) 1 week before and after each treatment session.
- •Subjects that are currently or have recently been treated with Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.
- •Subjects that have been on a steroid regimen within the past 3 months.
结局指标
主要结局
Acne lession count
时间窗: 3 months post treatment
acne count post treatment compared to based line count
次要结局
未报告次要终点