Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck

Официальное название

Evaluation of the Effectiveness and Safety of the Ulthera® System for Treating Skin Laxity in the Lower Face, Submentum and Neck

Обзор

The purpose of this study is to demonstrate superiority of treatment with the Ulthera System compared to untreated control for the improvement of skin laxity of the lower face, submental area and neck and to demonstrate the safety of treatment with the Ulthera System for the improvement of skin laxity of the lower face, submental area and neck.

Вмешательства

• Устройство Ulthera System
  Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.

Первичные конечные точки

• Proportion of Participants With at Least "Improved" in Lower Face, Submental and Neck Skin Laxity on Global Aesthetic Improvement Scale as Determined by the Blinded Live Evaluator (eGAIS) at Day 90 Compared to Baseline Photographs [Срок оценки: Day 90]

Вторичные конечные точки (3)

• Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs [Срок оценки: Day 90]
• Treating Investigator's GAIS (iGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs [Срок оценки: Day 90]
• Participant's GAIS (pGAIS) Scores in Lower Face, Submental Skin and Neck Laxity at Day 90 Compared to Baseline Photographs [Срок оценки: Day 90]

Критерии участия

Критерии включения

• Mild to moderate lower face, submental and/or neck laxity, that is amenable to improvement with non-invasive intervention and not severe enough for surgical intervention.
• Willing to abstain from all other aesthetic treatments on ANY part of the face, submentum or neck, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the clinical investigation's duration.
• Willing and able to refrain from chronic use of aspirin, ibuprofen, naproxen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) for 10 to 14 days post-treatment.
• Has an adequate understanding of the Chinese language.
• Willing and able to comply with protocol requirements.

Критерии исключения

• Scarring in area(s) to be treated.
• Any active implants.
• Any metallic implants in area(s) to be treated.
• Any open wounds or lesions, including active herpes simplex, in the area(s) to be treated.
• Presence of an active systemic or local skin disease, including active, cystic, or severe inflammatory acne in the area(s) to be treated.
• History of keloid formation or hypertrophic scarring.
• History of the following cosmetic treatments in area(s) to be treated:

• Skin-tightening procedure,
• Injectable crosslinked hyaluronic acid (HA)/collagen temporary dermal fillers of the lower face, submentum or neck within the past 12 months.
• Injectable non-crosslinked HA dermal fillers of the lower face, submentum or neck within the past 6 months.
• Injectable semi-permanent/permanent facial fillers
• Neurotoxin treatment of the lower face, submentum or neck within the past 6 months.
• Liposuction of the lower face, submentum or neck within the last 12 months.
• Fat grafting of the lower face, submentum or neck within the last 12 months.
• Deoxycholic acid within the last 12 months; and/or
• Chemical peeling or dermabrasion treatments within the past 12 months.
• Cryolipolysis
• Had prior surgery in the lower-facial area and/or neck/submentum or has a permanent implant or graft in the lower-facial area that could interfere with effectiveness assessments.
• Has undergone oral surgery in the past 30 days.
• Participants who have used isotretinoin or other retinoid medications within 6 months prior to enrollment or have applied topical retinoid-containing medications on the face or neck area within 2 weeks prior to enrollment or planning such treatments during the study period.
• Marked facial asymmetry, deep dermal scarring, or thick sebaceous skin in the full face.
• Severe solar elastosis.
• Facial nerve palsy or history of facial nerve palsy.
• Tattoos in the area(s) to be treated (excluding microblading eyebrow).
• Current smoker or history of smoking in the last 12 months.
• Current daily user of any nicotine-containing products
• Is a female of childbearing potential1 and not using medically effective birth control 2 or is pregnant, lactating, or planning to become pregnant during the clinical investigation.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Merz Investigative Site — Пекин
• Merz Investigative Site — Пекин
• Merz Investigative Site — Гуанчжоу
• Merz Investigative Site — Нанкин
• Merz Investigative Site — Сиань
• Merz Investigative Site — Шанхай
• Merz Investigative Site — Шанхай

Идентификаторы

NCT: NCT07614997 · ULT-LAX-CN002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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