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Набор скоро начнётся NCT07723664

Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation

Без фазы С лечением Facial Wrinkles Jawline Contour Skin Laxity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SofWave.
Кому может быть актуально
Состояния в реестре: Facial Wrinkles, Jawline Contour, Skin Laxity. Базовые параметры: 40 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

Non-randomized single-arm prospective clinical study.

Подробное описание

Eligible subjects will receive 1 or 2 SofWave treatments (4-6 weeks apart) using the Total Treatment Energy (TTE) methods and will return to 3 follow up visits: at 4 weeks ± 2 weeks post last treatment (FU1), at 12 weeks ± 2 weeks post last treatment (FU2) , at 24 weeks ± 4 weeks post last treatment (FU3).

Вмешательства

  • Устройство SofWave
    The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues

Первичные конечные точки

  • Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation [Срок оценки: 12 weeks post treatment follow-up visit]
  • Lower face and upper neck rejuvenation [Срок оценки: 12 weeks post treatment follow-up visit]

Критерии участия

Критерии включения

  • Healthy female and male subjects between the ages 40-55.
  • Non-Smoker.
  • Fitzpatrick skin type I-VI.
  • Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
  • Presence of mild to moderate laxity in the lower face and submental area.
  • Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
  • Able to understand and provide written Informed Consent.
  • Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
  • Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
  • Stable weight over the last 12 weeks and throughout the duration of the study.
  • Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+.
  • Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography.

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Критерии исключения

  • Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
  • Presence of any active systemic or local infections.
  • Open wounds or lesions within the intended to treat area.
  • Tattoo or former tattoo at or near treatment area.
  • Presence of active local skin disease that may alter wound healing.
  • Uncontrolled diabetes mellitus.
  • Skin cancer in the area to be treated. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
  • Severe solar elastosis.
  • History of smoking in the past 10 years.
  • History of chronic drug or alcohol abuse.
  • Excessive subcutaneous fat on the cheeks.
  • Significant scarring in the area to be treated or history of keloids.
  • Severe or cystic facial acne, and/or Accutane use during the past 6 months.
  • Pacemakers and electronic device implants in the treated area.
  • Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
  • Inability to understand the protocol or to provide a signed informed consent.
  • History of cosmetic treatments in the area to be treated including:
  • Chemical peels, microneedling, dermabrasion, energy-based devices, or laser treatments in the past 6 months
  • Injectable filler treatments in the past 6 months
  • Injectable neuromodulator treatment in the past 4 months
  • Cosmetic surgical procedures in the treatment area, including but not limited to facelift in the past 12 months.
  • Taking anti-platelet or anti-coagulant within the past 2 weeks.
  • Ongoing use of psychiatric medication; taking psychiatric drugs within the past 2 weeks.
  • As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

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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

США · 1 центр
  • Dermatology & Laser Surgery Center — Houston

Идентификаторы

NCT: NCT07723664 · SofWave31

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗