Меню
Идёт набор NCT07146022

Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)

Фаза III С лечением Androgenetic Alopecia (AGA) Androgenetic Alopecia AGA Female 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: VDPHL01 QD, Placebo, VDPHL01 BID, Placebo.
Кому может быть актуально
Состояния в реестре: Androgenetic Alopecia (AGA), Androgenetic Alopecia, AGA, Female Androgenetic Alopecia. Базовые параметры: 18 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 →

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

Официальное название

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Female Subjects With Androgenetic Alopecia

Обзор

This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA). AGA is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormones) that causes hair loss. VDPHL01 is an investigational oral drug to treat AGA. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).

Подробное описание

Not required.

Вмешательства

  • Препарат VDPHL01 QD
    VDPHL01 Extended Release (ER) Tablet
  • Препарат Placebo
    Placebo tablet
  • Препарат VDPHL01 BID
    VDPHL01 Extended Release (ER) Tablet
  • Препарат Placebo
    Placebo tablet

Первичные конечные точки

  • Changes in non-vellus Target Area Hair Counts (TAHC) [Срок оценки: Month 6]
  • Subjects Evaluation of Treatment Benefit [Срок оценки: Month 6]

Критерии участия

Критерии включения

  • Subject is a female aged 18-65 years old;
  • Subject has a clinical diagnosis of mild to moderate AGA;
  • Subject is in good general health and has adequate renal and hepatic function;
  • Subject is willing to maintain at least 1/4 inch length hair during the study with the same hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study;
  • Subject is willing and able to administer the test article as directed and can read, understand, and complete the required questionnaires in English;
  • Subject is willing and able to swallow study drug whole;
  • Subject agrees to have a micro dot tattoo placed on their scalp;
  • Subject agrees to have this area photographed at study visits as indicated in the protocol.

Критерии исключения

  • Subject has uncontrolled blood pressure or orthostatic hypotension;
  • Subject has symptoms or history of certain heart or thyroid conditions;
  • Subject has a history of or active hair loss due to conditions/diseases other than AGA;
  • Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists;
  • Subject has been diagnosed with COVID-19 within 16 weeks of baseline;
  • Subject has had previous radiation of the scalp;
  • Use of any of the following treatments within the indicated washout period before screening:
  • Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening
  • Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening
  • Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening
  • Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening
  • Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening
  • Subject has used any topical scalp treatments for hair growth within 12 weeks prior to screening
  • Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study;
  • Subject has any other condition that, in the investigator's opinion, interfere with the study

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 71 центр
  • Site 73 — Birmingham
  • Site 89 — Birmingham
  • Site 77 — Phoenix
  • Site 30 — Fort Smith
  • Site 69 — Encino
  • Site 2 — Fremont
  • Site 64 — Manhattan Beach
  • Site 93 — Northridge
  • … и ещё 63 центра

Идентификаторы

NCT: NCT07146022 · 250-13951-306

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗