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Идёт набор NCT06385171

Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation

— Наблюдательное 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: Botulinum toxin type A.
Кому может быть актуально
Состояния в реестре: Wrinkle. Базовые параметры: 20 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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Обзор

A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable.

Подробное описание

The primary purpose of this clinical trial is to evaluate the efficacy and safety of Botulinum Toxin Type A in the treatment of facial wrinkles among a diverse population, with a specific aim to bridge the gap between cosmetic injectables and varying financial statuses of potential patients. This study intends to determine the degree to which Botulinum Toxin Type A can reduce the appearance of facial wrinkles, identify the optimal dosage for significant cosmetic improvement with minimal side effects, and assess patient satisfaction with the outcomes. By conducting a rigorous, controlled, and open label methodology, this research aspires not only to provide comprehensive data supporting the use of Botulinum Toxin Type A as a safe and effective treatment for aesthetic improvement but also to make such treatments more accessible and affordable. This endeavor seeks to democratize cosmetic enhancements, ensuring that individuals across different economic backgrounds can benefit from advancements in cosmetic dermatology. Ultimately, the study aims to offer valuable insights into cost-effective practices without compromising treatment quality, thereby enhancing patient care practices and contributing significantly to the field of cosmetic dermatology.

Вмешательства

  • Препарат Botulinum toxin type A
    The intervention involves the administration of Botulinum Toxin Type A, with dosages regulated according to FDA guidelines. Each injection site will receive a maximum of 4 units, adhering to the FDA's recommended dosage limits. Dosages administered will be tailored to each patient's needs and will be recorded in their individual patient information chart.

Первичные конечные точки

  • Change in facial wrinkles and Lines [Срок оценки: Upto 2 years]
  • Facial Appearance [Срок оценки: Upto 2 years]
  • Assessment of Wrinkle Severity [Срок оценки: Upto 2 years]
Вторичные конечные точки (1)
  • Assessment of Skin Reaction [Срок оценки: Upto 2 years]

Критерии участия

Критерии включения

  • Individuals of both genders.
  • Must be in good physical health.
  • Age between 20 and 65 years.
  • Presence of both static (unchanging) and moderate dynamic (movement-induced) wrinkles on the forehead or glabellar region.
  • Must possess the willingness and ability to understand and provide informed consent, as well as effectively communicate with study personnel.

Критерии исключения

  • Pregnant or breastfeeding female.
  • Age below 20 or above 65 years.
  • History of neuromuscular disorders, such as myasthenia gravis.
  • History of facial surgery or presence of scars in the treatment area that could potentially interfere with or confound the results of the study.
  • Recent treatment history within the past 6 months in the forehead or glabellar region, including:
  • Ablative laser procedures.
  • Radiofrequency device treatments.
  • Ultrasound device treatments.
  • Medium to deep chemical peels.
  • Temporary soft tissue augmentation.
  • Semi-permanent soft tissue augmentation within the past 2 years.
  • Permanent soft tissue augmentation.
  • Planned cosmetic procedures within the next 6 months in the same region.
  • Intended use of tretinoin or retinoic acid within the next 6 months.
  • Presence of active infection in the treated area, excluding mild acne.
  • Allergy to cow's milk protein or albumin.
  • Use of aminoglycoside medications.
  • Current use of anticoagulation therapy.
  • History of bleeding disorders.
  • Diagnosis of mental illness.
  • Inability to comprehend the study protocol or provide informed consent.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • Global Aesthetics LLC — Cisco
  • Global Aesthetics LLC — Lubbock

Идентификаторы

NCT: NCT06385171 · FFA-BTX-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗