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Идёт набор NCT03793348

Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

Без фазы С лечением Wrinkle

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: MCD.
Кому может быть актуально
Состояния в реестре: Wrinkle. Базовые параметры: 40 лет — 70 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

Обзор

Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles

Подробное описание

Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment.

Study results will be assessed with the following:

* Lemperle Scale * Investigator GAIS Scale * Subject Satisfaction Scale

Вмешательства

  • Устройство MCD
    Micro coring skin removal with automated coring device

Первичные конечные точки

  • Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale [Срок оценки: 90 day post treatment]
Вторичные конечные точки (6)
  • Assess aesthetic improvement using Global Aesthetic Improvement Scale [Срок оценки: 90 day post treatment]
  • Assess aesthetic improvement using Subject Satisfaction Scale [Срок оценки: 90 day post treatment]
  • Assess aesthetic improvement in wrinkles using OCT images (optional) [Срок оценки: Baseline to Day 90 post treatment]
  • Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment. [Срок оценки: Baseline to Day 90 post treatment]
  • Assess safety profile by recording of adverse events [Срок оценки: Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE.]
  • Assess safety profile by reviewing completed 14 day subject diary for potential side effects. [Срок оценки: For 14 days post treatment]

Критерии участия

Критерии включения

  • Males and females 40-70 years of age
  • Fitzpatrick Skin Type I to IV as judged by the Investigator
  • Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
  • Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.

Критерии исключения

  • Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
  • History of keloid formation or hypertrophic scarring
  • History of trauma or surgery to the treatment areas in the past 6 months
  • Scar present in the areas to be treated
  • Silicone injections in the areas to be treated
  • Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
  • Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
  • Active, chronic, or recurrent infection
  • History of compromised immune system or currently being treated with immunosuppressive agents
  • History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
  • Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
  • Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
  • History or presence of any clinically significant bleeding disorder
  • Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
  • Treatment with an investigational device or agent within 30 days before treatment or during the study period

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 · 6 центров
  • Laser and Skin Surgery Center of Northern California — Sacramento
  • AboutSkin Research, LLC — Greenwood Village
  • Miami Dermatology & Laser Institute — Miami
  • Laser and Skin Surgery of New York — New York
  • The Office of Brian Biesman, M.D. — Nashville
  • Dallas Plastic Surgery Institute — Dallas

Идентификаторы

NCT: NCT03793348 · AIS 700-00052

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗