Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles

Официальное название

A Prospective, Interventional, Evaluator-Blinded, Multi-Center Study for the Assessment of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Epicare
  All participants will receive treatment with the Epicare fractional nano-thulium (Tm:YAP, 1938 nm) laser device for the reduction of periorbital wrinkles.

Первичные конечные точки

• Fitzpatrick Wrinkle Classification Scale (FWCS) improvement after three months from last treatment. [Срок оценки: 3 months post-Treatment #2]

Вторичные конечные точки (6)

• Physician-Reported GAIS Improvement [Срок оценки: 3 months post-Treatment #2]
• Physician-Reported FWCS Improvement [Срок оценки: 3 months post-Treatment #2]
• Subject-Reported GAIS [Срок оценки: 3 months post-Treatment #2]
• Subject-Reported S-GSQ [Срок оценки: 3 months post-Treatment #2]
• Pain Assessment Using Visual Analog Scale (VAS) After Each Treatment [Срок оценки: Immediately post-procedure at each treatment visit]
• Subjective Downtime Assessment After Each Treatment [Срок оценки: Collected at Week 1 post-treatment follow-up visits for each treatment session.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07114562 · PL-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗