Идёт набор NCT07399028

A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging

Без фазы С лечением Volume Deficiency in the Mid-Face Skin Laxity Photo-aged Skin

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: Sculptra®.
Кому может быть актуально: Состояния в реестре: Volume Deficiency in the Mid-Face, Skin Laxity, Photo-aged Skin. Базовые параметры: 45 лет — 65 лет · Женщины.
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 →

Официальное название

A Single-center, Open-label Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging

Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.

Устройство Sculptra®
Sculptra injection will be performed to the cheeks using 25 G needle size. Injections will be performed subdermally, i.e., in the subcutaneous and supraperiosteal region. A maximum of 18 mL (2 vials) of Sculptra will be administered per treatment session with a maximum of 9 mL (1 vial) per cheek, evenly distributed within the treatment area.

Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging [Срок оценки: 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline]

Adult subjects aged 45-65 years old
Females only
Subject with moderate-to-severe cheek wrinkles on the GCWS
Subject with intent to undergo correction of cheek wrinkles on both sides of the face
Subject who in the opinion of the Investigator would need 3 treatments for optimal clinical outcomes
Subject willing to be photographed at each visit.
Subjects willing to stop using current facial skincare products for the duration of the study.
Subject willing to replace the current facial skincare products with the provided facial skincare products, including cleanser, moisturizer and sunscreen, until study completion.
Ability to read, understand and give consent for participation in the study.
Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.

Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.

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

Здоровые добровольцы: Нет

США · 1 центр

NCT: NCT07399028 · GLI.04.US.SL.050

Бесплатно. Мы поможем связаться с центром и подготовить документы; решение об участии принимает врач исследовательского центра.