A Prospective, Interventional, Evaluator-Blinded, Multi-Center Study for the Assessment of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Fitzpatrick Wrinkle Classification Scale (FWCS) improvement after three months from last treatment.
研究概览
简要总结
This is a prospective, interventional, evaluator-blinded, multi-center clinical study designed to assess the safety and performance of the Epicare fractional nano-thulium (Tm:YAP 1938 nm) laser system for the treatment of moderate to severe periorbital wrinkles in adults aged 25-65. Up to 50 participants will receive one Epicare treatment at baseline, with an optional second treatment at Month 2 based on clinical assessment. The primary endpoint is the proportion of participants achieving at least a 1-grade improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) three months after the last treatment, as evaluated by at least 2 of 3 independent, blinded reviewers of standardized photographs.
详细描述
The Epicare device utilizes fractional nano-thulium (Tm:YAP 1938 nm) laser technology to create precise ablative micro-columns surrounded by adjustable coagulative zones, stimulating collagen regeneration and dermal remodeling while minimizing thermal injury and downtime. This clinical investigation will enroll 50 adults with Fitzpatrick skin types I-V and bilateral, approximately symmetrical periorbital wrinkles (FWCS 4-9).
Participants undergo standardized photography, FWCS scoring, GAIS evaluations, pain assessment (VAS), downtime assessments, and adverse event monitoring. Treatment #1 occurs at baseline and an optional Treatment #2 may be performed at Month 2. The End-of-Study visit occurs 3 months after the last treatment (Month 5 for two-treatment participants).
The study evaluates performance outcomes (FWCS, GAIS, satisfaction) and safety (device-related adverse events). No interim analysis is planned. Data will be analyzed descriptively. This pivotal clinical investigation is intended to establish the safety and performance of the Epicare device for aesthetic treatment of periorbital wrinkles.
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
Evaluator-Blinded (photograph reviewers; subjects and investigators unblinded)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 25-65 years of age, in general good health.
- •Seeking a reduction in the appearance of periorbital wrinkles.
- •Bilateral and approximately symmetrical periorbital wrinkles with a Fitzpatrick Wrinkle Classification Scale (FWCS) score 4-9, as assessed by the treating investigator.
- •Fitzpatrick skin type I-V.
- •Able to understand the study requirements and sign an EC/IRB-approved informed consent form prior to any study procedures.
- •Willing and able to comply with the treatment and follow-up schedule, pre- and post-treatment instructions, and allow standardized photography.
- •Willing to withhold additional aesthetic therapies to the treatment area (e.g., fillers, resurfacing procedures) for the entire study duration.
排除标准
- •Known bleeding disorder (e.g., thrombocytopenia, thrombasthenia, von Willebrand's disease).
- •Immunocompromised or immunosuppressed (e.g., AIDS, HIV, or immunosuppressive therapy).
- •Planned or recent use of anti-platelets, anti-coagulants, thrombolytics, ACE inhibitors, vitamin E, or anti-inflammatory drugs from 1 week prior to 1 month after treatment.
- •Systemic corticosteroid or anabolic steroid use within 30 days prior to enrollment (standard inhaled/nasal corticosteroids are permitted).
- •Use of weight loss medications before or during the study.
- •History of chronic or recurrent infection or inflammation that would preclude participation.
- •Severe allergies with history of anaphylaxis.
- •History of malignancy within 5 years prior to enrollment.
- •Infection, inflammation, or active dermatologic disease in the face.
- •Pregnant, breastfeeding, or planning pregnancy during the study; women of childbearing potential not using reliable contraception for ≥3 months prior and throughout the study.
- •Exposure to an investigational drug or device within 3 months prior to enrollment or during the study.
- •Prior permanent facial injections (e.g., silicone, grafting) or any upper-face surgery.
- •Neurotoxin treatments in the upper face within 6 months prior to enrollment.
- •Semi-permanent filler (e.g., collagen, CaHA) or any dermal filler (e.g., hyaluronic acid) in the upper face within 18 months prior to enrollment.
- •Any active or passive implant in the treatment area (metallic, silicone, electronic, or injected chemical substance).
- •Initiation of over-the-counter anti-wrinkle products (e.g., alpha-hydroxy acids) or prescription treatments (e.g., Retin-A, micro-dermabrasion, chemical peels) within 4 weeks prior to enrollment or planned use during the study.
- •Occupations involving continuous or routine sun exposure (e.g., lifeguards, outdoor workers).
- •History of smoking within the past 5 years.
- •Planned bariatric surgery or recent drastic weight loss.
- •Unstable body weight during the study.
- •Any other medical condition, laboratory abnormality, or investigator judgment that could affect compliance, safety, or data integrity.
结局指标
主要结局
Fitzpatrick Wrinkle Classification Scale (FWCS) improvement after three months from last treatment.
时间窗: 3 months post-Treatment #2
Proportion of participants achieving ≥1-grade improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) three months after Treatment #2, evaluated by ≥2 of 3 independent blinded reviewers.
次要结局
- Pain Assessment Using Visual Analog Scale (VAS) After Each Treatment(Immediately post-procedure at each treatment visit)
- Subjective Downtime Assessment After Each Treatment(Collected at Week 1 post-treatment follow-up visits for each treatment session.)
- Physician-Reported GAIS Improvement(3 months post-Treatment #2)
- Physician-Reported FWCS Improvement(3 months post-Treatment #2)
- Subject-Reported GAIS(3 months post-Treatment #2)
- Subject-Reported S-GSQ(3 months post-Treatment #2)
- Pain Assessment Using Visual Analog Scale (VAS) After Each Treatment(Immediately post-procedure at each treatment visit)
- Subjective Downtime Assessment After Each Treatment(Collected at Week 1 post-treatment follow-up visits for each treatment session.)