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Идёт набор NCT07429253

Secretome vs. PRP Injections for Hair Density and Growth in Androgenetic Alopecia Patients

Фаза I / Фаза II 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: Secretome, Platelet-Rich Plasma (PRP) Injections.
Кому может быть актуально
Состояния в реестре: Androgenetic Alopecia. Базовые параметры: 25 лет — 59 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
Индонезия
Следующий шаг
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Официальное название

Comparative Effectiveness of Secretome Injection and Intradermal Platelet-Rich Plasma Injection on Hair Density and Terminal-to-Vellus Hair Ratio in Patients With Androgenetic Alopecia at Prof. Dr. I.G.N.G. Ngoerah General Hospital

Обзор

This study aims to compare the effectiveness of secretome injection and intradermal platelet-rich plasma (PRP) injection on hair density and the terminal-to-vellus hair ratio in patients with androgenetic alopecia at Prof. Dr. I.G.N.G. Ngoerah General Hospital.

Подробное описание

This research is an experimental study with a randomized controlled clinical design involving two intervention groups: one receiving secretome injections and the other receiving intradermal platelet-rich plasma injections. Evaluations are conducted by measuring hair density and the terminal-to-vellus hair ratio before and after treatment using trichoscopy/dermoscopy.

Вмешательства

  • Биопрепарат Secretome
    UC-MSC secretome was injected intradermally into the scalp at the alopecia site, with injections spaced 1 cm apart and administered every 2 weeks for 8 weeks
  • Биопрепарат Platelet-Rich Plasma (PRP) Injections
    The centrifuged plasma solution was injected intradermally into the scalp at the alopecia site, with 0.1 ml per injection point spaced 1 cm apart, administered every 2 weeks for 8 weeks

Первичные конечные точки

  • Terminal-to-Vellus Hair Ratio [Срок оценки: Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)]
  • Hair density [Срок оценки: Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)]

Критерии участия

Критерии включения

  • Male patients with androgenetic alopecia, aged 25 to 59 years, with clinical presentation consistent with Hamilton-Norwood grades II to VI, seeking treatment at the Dermatology and Venereology Outpatient Clinic of Prof. Dr. I.G.N.G. Ngoerah General Hospital.
  • Female patients with androgenetic alopecia, aged 25 to 59 years, with clinical presentation consistent with Ludwig grades I to III, seeking treatment at the Dermatology and Venereology Outpatient Clinic of Prof. Dr. I.G.N.G. Ngoerah General Hospital.
  • Female patients who are not currently pregnant or breastfeeding.
  • Patients who have discontinued anti-androgen medication and minoxidil for at least 1 month prior to the procedure.
  • Patients with no known allergies to secretome components and/or materials used in the platelet-rich plasma (PRP) preparation process.
  • Patients who are proficient in Indonesian and willing to provide written informed consent.

Критерии исключения

  • Participants who are unable to speak or understand Indonesian and/or are unwilling to provide written informed consent.
  • Patients presenting with types of hair loss other than androgenetic alopecia.
  • Patients currently undergoing therapy with 5-alpha reductase inhibitors.
  • Patients who have received intradermal corticosteroid injections to the scalp within at least 6 months prior to the study.
  • Patients with active infections and/or active dermatitis on the scalp.
  • Patients with a known history of allergy to secretome components and/or materials used in the platelet-rich plasma (PRP) preparation process.
  • History of hypertrophic scarring or blood clotting (coagulation) disorders.
  • Patients unable to complete the research procedures in their entirety.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Индонезия · 1 центр
  • Prof. dr. I.G.N.G. Ngoerah Central General Hospital — Denpasar

Идентификаторы

NCT: NCT07429253 · CT/ALP/02/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗