A Prospective, Single-center, Investigator-blinded Trial to Evaluate the Safety and Efficacy of Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Wrinkles
研究概览
简要总结
To assess the safety, efficacy and patient satisfaction associated with the treatment of facial wrinkles using the Secret Micro-Needle Fractional RF System® (Ilooda Co., Ltd., Suwon, South Korea).
详细描述
Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. After baseline evaluation, all subjects will undergo a series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.
Blinded-investigator and subject self-assessments will be performed at Baseline and Days 28, 56, 146, and 180 to evaluate treatment efficacy for facial wrinkling. Of note, the blinded-investigators will be blinded to treatment settings and technique, and number of treatments. Safety will be evaluated by subject diaries, as well as investigator- and subject-rated evaluations of adverse events at all follow-up visits. Mandatory standard 2D digital photography, Canfield VISIA and VECTRA 3D digital photography will be performed at baseline and at each office visit.
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
盲法说明
Blinded-investigator assessments will be performed at Baseline and Days 28, 56, 146, and 180 to evaluate treatment efficacy for facial wrinkling. Of note, the blinded-investigators will be blinded to treatment settings and technique, and number of treatments.
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
- •Males or females in good general health who are greater than 22 years of age.
- •Subjects may be of Fitzpatrick Skin Types I through VI.
- •Subjects must desire improvement of facial skin texture and wrinkling.
- •Subjects must have at least a score of 2 on the Fitzpatrick Wrinkle Scale evaluating the forehead, cheeks, and periorbital areas and Modified Fitzpatrick Wrinkle Scale evaluating the nasolabial folds (Appendix A1 and A2).
- •Subjects must be willing to provide written informed consent, HIPAA authorization, and photographic release.
- •Subjects must be willing to follow study instructions and complete all required visits.
- •Negative urine pregnancy test results at the time of study entry (if applicable).
- •The subject is healthy as judged by medical history and investigator's assessment of current health
- •Female subjects will be either of non-childbearing potential defined as:
- •Having no uterus.
- •No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
- •Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device (systemic birth control must have been started 30 days or more prior to enrolling)
- •Intrauterine coil
- •Bilateral tubal ligation
- •Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- •Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
- •Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with non-vasectomized).
排除标准
- •A subject who has undergone treatment with any non-ablative laser, including IPL, within the last 3 months and any ablative laser within the last 6 months.
- •A subject who has undergone any microneedling treatment within the last 3 months
- •A subject with a history of previous fat transfer, injectable calcium hydroxylapatite or poly-l-lactic acid to the study area within the past 6 months.
- •A subject with a history of injection of hyaluronic acid dermal fillers in the study area within the past six months.
- •Retinoid, hydroquinone, microdermabrasion, or chemical peel treatments to the face within one month prior to study participation or during the study.
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research studies.
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Presence of scarring, sunburn, tattoos, open wounds or other skin condition in area to be treated that would interfere with the assessments of this study.
- •Individuals who have current skin cancers or suspicious lesions in the treatment area per Investigator.
- •Individuals who are nursing, pregnant, or planning to become pregnant during the study.
- •Patients who have a history with keloid formation or hypertrophic scarring.
- •Inability to understand the protocol or to give informed consent.
- •Subjects with deep dermal scarring or thick sebaceous skin of the treatment area.
- •History of impaired immune system, including but not limited to HIV, current malignancy.
- •History of chronic drug or alcohol abuse.
- •Current smoker or history of smoking in the last one year.
- •Subjects with known bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection per investigator discretion.
- •Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- •Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- •Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- •History of using the following prescription medications:
- •Current use of psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
- •Immunosuppressive medications.
- •Subjects with implantable cardiac devices, such as pacemakers or implantable cardioverter-defibrillators.
研究组 & 干预措施
Treatment
After baseline evaluation, all subjects will undergo a series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.
干预措施: Secret RF (Device)
结局指标
主要结局
Wrinkles
时间窗: Baseline to Day 146
Improvement in Wrinkles Based on the Fitzpatrick Wrinkle Scale
次要结局
- Global Aesthetic Improvement Score(Baseline to Day 28, 56, and 146)
- Rating of Non-Sequential Images(Baseline, Day 28, and Day 56.)
- Subject Satisfaction(Baseline to Day 28, 56, and 146)