Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.
研究概览
简要总结
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate 50 treatment sites in subjects requesting treatment of their acne scarring. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded assessment of photographs taken at baseline and 6, 12 weeks post final treatment by independent evaluators.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, male or female subjects 22 years of age or over who are seeking treatment and reduction of their facial acne scarring.
- •Able to read, understand and voluntarily provide written Informed Consent.
- •Able and willing to comply with the treatment/follow-up schedule and requirements.
- •Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
排除标准
- •Implantable defibrillators, cardiac pacemakers, and other metal implants
- •Subjects with any implantable metal device in the treatment area
- •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- •Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- •Current or history of any kind of cancer, or pre-malignant moles.
- •Severe concurrent conditions, such as cardiac disorders.
- •Pregnancy or intending to become pregnant during the study and nursing.
- •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 in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment, or according to Investigator's discretion .
- •Poorly controlled endocrine disorders, such as diabetes.
- •Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- •History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- •History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
- •Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
- •Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.
- •Any surgical procedure in the treatment area within the last six months or before complete healing.
- •Treating over tattoo or permanent makeup.
- •Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
- •As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
结局指标
主要结局
Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.
时间窗: 12 Weeks Post-Final Treatment
Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a seven-grade subjective test. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).
次要结局
- Subject Scale - Visual Analog Scale for Pain(12 Weeks Post-Final Treatment)
- Subject Scale - 5 Point Scale for Treatment Tolerability(12 Weeks Post-Final Treatment)
- Subject Satisfaction(6 Weeks and 12 Weeks Post- Final Treatment)
- Number of Participants With Treatment-Related Adverse Events [Safety](Up to 12 Weeks Post-Final Treatment)