Меню
Набор скоро начнётся NCT07689344

Poly-L-lactic Acid (PLLA) Injection for Neck Skin Laxity: A Pilot Study

Без фазы С лечением Skin Aging Wrinkles

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: Poly-L-Lactic Acid (Sculptra) injection.
Кому может быть актуально
Состояния в реестре: Skin Aging, Wrinkles. Базовые параметры: 30 лет — 60 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
Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Efficienctiveness of Poly-L-Lactic Acid, PLLA for the Treatment of Skin Laxity of the Neck: A Pilot Study

Обзор

Skin aging of the neck commonly leads to wrinkles and skin laxity due to the gradual loss of collagen and structural support in the skin. Although several treatments are available, effective non-surgical options for improving neck skin laxity remain limited. This pilot study aims to evaluate the effectiveness and safety of Poly-L-Lactic acid (PLLA) injections for improving neck skin laxity.

Подробное описание

This study is a prospective pilot interventional study designed to evaluate the effectiveness and safety of Poly-L-Lactic acid (PLLA) injections for the treatment of neck skin laxity. Eligible Thai male and female participants aged 30 to 60 years with neck skin laxity grades 1 to 4 according to the Neck Skin Laxity Scale (NSL scale) will be enrolled. Participants will receive a single treatment session of PLLA injection to the neck using a cannula technique in the subcutaneous plane with a linear retrograde fanning method through lateral entry points. Approximately 8 mL of PLLA solution will be injected on each side of the neck, for a total volume of 16 mL per participant. Clinical outcomes will be evaluated at baseline and during follow-up visits at weeks 8, 16, and 24. Outcome measures include improvement in neck skin laxity assessed using the NSL scale, changes in skin elasticity measured by using the Cutometer® Dual MPA 580, participant satisfaction, and treatment-related adverse events. Outcome assessment will be performed by comparing follow-up measurements with baseline values.

Вмешательства

  • Препарат Poly-L-Lactic Acid (Sculptra) injection
    Poly-L-Lactic acid (PLLA) is used as a collagen-stimulating injectable for the treatment of neck skin laxity. The PLLA solution is prepared by reconstituting PLLA with sterile water and lidocaine to a total volume of 16 mL. Participants will receive a single treatment session of PLLA injection to the neck using a cannula technique. The injection is performed in the subcutaneous plane using a linear retrograde fanning technique through lateral entry points of the neck. Approximately 8 mL of PLLA

Первичные конечные точки

  • Change in Neck Skin Laxity Scale (NSL scale) Score [Срок оценки: Baseline (Week 0), Week 8, Week 16, and Week 24]
Вторичные конечные точки (3)
  • Participant-Reported Neck Appearance Satisfaction Score Assessed Using the 5-Point Neck Appearance Satisfaction Scale [Срок оценки: Baseline (Week 0), Week 8, Week 16, and Week 24]
  • Change in skin Firmness and Elasticity Assessed by Cutometer® Dual MPA 580 [Срок оценки: Baseline (Week 0), Week 8, Week 16, and Week 24]
  • Incidence of Treatment-Related Adverse Events [Срок оценки: Immediately after PLLA injection (Week 0), Week 8, Week 16, and Week 24]

Критерии участия

Критерии включения

  • Thai male or female participants aged 30-60 years
  • Individuals who wish to improve neck skin laxity
  • Presence of neck skin laxity grade 1-4 according to the Neck Skin Laxity Scale (NSL scale)

Критерии исключения

  • Pregnant or breastfeeding women
  • History of allergy or hypersensitivity to local anesthetics or components of collagen-stimulating substances
  • Active autoimmune disease requiring systemic treatment
  • History of cosmetic procedures in the neck area, including laser treatment, radiofrequency, or ultrasound-based devices within 6 months prior to treatment
  • History of dermal filler injection in the neck area
  • History of botulinum toxin injection in the neck area within 6 months prior to treatment

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

Таиланд · 1 центр
  • Institute of Dermatology — Ratchathewi

Публикации

  • Christen MO. Collagen Stimulators in Body Applications: A Review Focused on Poly-L-Lactic Acid (PLLA). Clin Cosmet Investig Dermatol. 2022 Jun 21;15:997-1019. doi: 10.2147/CCID.S359813. eCollection 2022. PMID 35761856
  • Tateo A, Siquier-Dameto G, Artzi O, Humzah D, Molina B, Jain R, Lanzarotti A, Laouedj M, Dapis N, Bellia G. Development and Validation of IBSA Photographic Scale for the Assessment of Neck Laxity. Clin Cosmet Investig Dermatol. 2021 Apr 7;14:349-354. doi: 10.2147/CCID.S302860. eCollection 2021. PMID 33854352
  • Nikolis A, Avelar LE, Enright KM. Evaluation of Cannula Safety in Injection of Poly-L-Lactic Acid. Clin Cosmet Investig Dermatol. 2021 Jun 10;14:615-622. doi: 10.2147/CCID.S305479. eCollection 2021. PMID 34140793
  • Mazzuco R, Hexsel D. Poly-L-lactic acid for neck and chest rejuvenation. Dermatol Surg. 2009 Aug;35(8):1228-37. doi: 10.1111/j.1524-4725.2009.01217.x. Epub 2009 May 12. PMID 19438668

Идентификаторы

NCT: NCT07689344 · 006/2568

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗