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Набор скоро начнётся NCT07248410

A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia

Без фазы С лечением Androgenetic Alopecia

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: fraction laser.
Кому может быть актуально
Состояния в реестре: Androgenetic Alopecia. Базовые параметры: 18 лет — 50 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This trial aims to evaluate the efficacy, safety, and tolerability of fractional laser combined with topical exosome for hair regrowth in patients with androgenetic alopecia. This study is expected to recruit 30 participants. The experimental group will receive fractional laser treatment combined with human umbilical cord mesenchymal stem cell exosome solution; the control group will receive fractional laser treatment combined with a placebo. Participants will receive three fractional laser treatments and will be followed up for 6 months. At each follow-up visit, hair density, diameter, vellus hair to terminal hair ratio, and adverse reactions will be assessed using trichotomy; a global photographic assessment will be performed using standardized imaging equipment.

Вмешательства

  • Устройство fraction laser
    We will performed the fraction laser on the scalp of participants with energy of 30-40mJ every month for 3 times.

Первичные конечные точки

  • Change in hair density (d84) [Срок оценки: Baseline to Day 84]
Вторичные конечные точки (4)
  • Change in hair density (d168) [Срок оценки: Baseline to Day 168]
  • Change in Hair diameter (d168) [Срок оценки: Baseline to Day 168]
  • Change in the percentage of vellus hair and terminal hair (d168) [Срок оценки: Baseline to Day 168]
  • Change in global photographic assessment (d168) [Срок оценки: Baseline to Day 168]

Критерии участия

Критерии включения

  • Male pattern baldness diagnosed according to the Norwood-Hamilton classification III-V
  • Males aged 18 to 50 years
  • Willing to provide written informed consent and possessing the ability to read, write, speak, and understand
  • Able to follow the study's treatment guidelines

Критерии исключения

  • Those who have taken oral Finasteride, Dutasteride, or Minoxidil within 6 months prior to the start of the trial.
  • Those who have used any topical or systemic medications that may affect hair growth within 6 months prior to the start of the trial.
  • Those who have received phototherapy, laser therapy, exosome therapy, or hair regrowth injections (such as minimally invasive procedures) within 6 months prior to the start of the trial.
  • Those with a history of hair transplant surgery.
  • Those suffering from other systemic or scalp diseases that may affect hair growth (e.g., iron deficiency anemia, immune disorders, thyroid diseases, and syphilis).
  • Those with a history of severe inflammation, keloids, malignant tumors, or poor wound healing at the treatment site.
  • Those with other diseases that make them unsuitable for fractional laser treatment.
  • Those with a history of malignant tumors or currently undergoing treatment.
  • Participants must not undergo any cosmetic procedures that may affect scalp condition or hair growth throughout the entire trial period, including hair dyeing, perming, bleaching, scalp exfoliation, deep scalp cleansing, or any other actions that may irritate or damage the scalp.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • Chang Gung Memorial Hospital Taoyuan branch — Taoyuan

Публикации

  • Suchonwanit P, Rojhirunsakool S, Khunkhet S. A randomized, investigator-blinded, controlled, split-scalp study of the efficacy and safety of a 1550-nm fractional erbium-glass laser, used in combination with topical 5% minoxidil versus 5% minoxidil alone, for the treatment of androgenetic alopecia. Lasers Med Sci. 2019 Dec;34(9):1857-1864. doi: 10.1007/s10103-019-02783-8. Epub 2019 Apr 13. PMID 30982177
  • Amini F, Teh JJ, Tan CK, Tan ESS, Ng ESC. A Pilot Randomized Controlled Trial (RCT) Evaluating the Efficacy of an Exosome-Containing Plant Extract Formulation for Treating Male Alopecia. Life (Basel). 2025 Mar 20;15(3):500. doi: 10.3390/life15030500. PMID 40141845
  • Chen YC, Tsai WC, Li ZX, Lin WJ, Lin HY, Hsieh YJ, Wang KH, Chen YY, Hwang TL, Lin TY. Exosomes from human umbilical cord mesenchymal stem cells promote the growth of human hair dermal papilla cells. PLoS One. 2025 Apr 30;20(4):e0320154. doi: 10.1371/journal.pone.0320154. eCollection 2025. PMID 40305498

Идентификаторы

NCT: NCT07248410 · ExoOne-CS-2025001a

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗