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Набор по приглашению NCT07260578

Safety and Efficacy of Ellacor® Micro-coring® Following Best Practices on Technique and Post-Procedural Care

Без фазы С лечением Best Practices Ellacor Micro-coring Post Care Ellacor Post Care

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: ellacor Micro-Coring Technology.
Кому может быть актуально
Состояния в реестре: Best Practices, Ellacor, Micro-coring Post Care, Ellacor Post Care. Базовые параметры: 45 лет — 65 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

Safety and Efficacy of Ellacor Micro-coring Following Best Practices on Technique and Post-Procedural Care

Обзор

Since its inception of being marketed in the United States in 2021, physicians have used various post procedure skin care regimen to facilitate recovery. This study aims to examine the use of three post care products in five skin care regimens

Вмешательства

  • Устройство ellacor Micro-Coring Technology
    ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.

Первичные конечные точки

  • Global Aesthetic Improvement Scale (GAIS) [Срок оценки: GAIS Assessment will be performed under a timeframe of 90 days]
Вторичные конечные точки (1)
  • Clinical Assessment [Срок оценки: Clinical assessment will be performed at each follow up throughout the study period.]

Критерии участия

Критерии включения

  • Male and female adult, between the ages of 45 and 65
  • Fitzpatrick Skin Type I to IV
  • Have moderate to severe wrinkles on the mid and lower face, according to Lemperle Wrinkle Severity Scale (LWSS), i.e. score 3, 4 or 5.
  • Willingness to sign Informed Consent Form

Критерии исключения

  • Pregnant women or nursing mothers
  • Patients with dermatosis, open wounds, sores, or irritated skin in the treatment area
  • Patients with allergy to stainless steel or to topical, oral, or injected medications or preparations that may be used during the procedure, such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
  • Patients with a history or presence of any clinically significant bleeding disorder

i. Patients with dermatological or autoimmune conditions that may affect the treatment outcome; these may include, but are not limited to: actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules/nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, or lupus e. Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection) f. Patients who are on a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days g. Patients who are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area h. Patients have undergone plastic surgery of the face within the last twelve (12) months or have any facial surgical scars less than twelve (12) months old i. Patients who have undergone injections of dermal fillers, fat, or botulinum toxin, as well as any minimally invasive/invasive skin treatment in the treatment area during the previous six (6) months j. Patients with scars less than six (6) months old in the treatment area k. During the study time frame, unwilling to refrain from receiving these following aesthetic treatments: toxin, filler, any skin resurfacing (laser, RF, ultrasound, microneedling, etc.); l. Have enrolled in another clinical trial during or overlapping part of this study m. Unwilling to have facial photography taken for the study purpose n. Any physical or psychological factors, in the judgment of the study investigator, may prevent subject from performing the procedure correctly.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 2 центра
  • Miami Dermatology And Laser Institute — Miami
  • Caloaesthetics Plastic Surgery Center — Louisville

Идентификаторы

NCT: NCT07260578 · TP-00456

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗