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Набор скоро начнётся NCT07637071

Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia

Без фазы С лечением Androgenic Alopecia Hair Loss/Baldness Hair Thinning

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: Xtressé Hair Growth Gummies.
Кому может быть актуально
Состояния в реестре: Androgenic Alopecia, Hair Loss/Baldness, Hair Thinning. Базовые параметры: 18 лет — 65 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement in Men With Androgenic Alopecia

Обзор

The goal of this study is to determine how safe and effective it is to improve hair growth using an active gummy treatment in men with androgenic alopecia. The main aims of this trial are: 1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair. 2. To gauge patient satisfaction with hair changes and application process. 3. Monitor and report any adverse events associated with the daily intake of Xtressé Participants who qualify will complete 3 visits after voluntary consent has been given. Participants will be given a 90-day supply of the gummies at visits 1 and 2 to cover the 6-month study period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.

Подробное описание

In the study, participants will be asked to complete the following:

Provide basic personal information (including date of birth, gender, race and ethnicity) Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight) Follow study rules such as avoiding certain medications and treatments Provide information on any medications, treatments or reactions that started after the study began Take gummy treatment daily and complete a treatment diary Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects

To qualify for this trial, participants must:

Be a male adult between 18 to 65 years of age Have hair loss in vertex region. Give voluntary written consent Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatments areas Allow photographs of the front and top area of the scalp Confirm they are not sensitive to any of the study treatment ingredients

All photographs of the treatment area collected during the study will be used as study data.

All participants have the right to refuse further participation in the study at any time.

Вмешательства

  • Другое Xtressé Hair Growth Gummies
    The nutraceutical supplement is powered by proprietary X-3 BioActive Blend and contains plant based extracts and regenerative compounds not commonly found in existing hair supplements. The dosage is 2 gummies taken once per day.

Первичные конечные точки

  • Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis [Срок оценки: From enrollment to the end of treatment at 6 months]
  • Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis [Срок оценки: From enrollment to the end of treatment at 6 months]
  • Hair Density Changes measured by SOCAi [Срок оценки: From enrollment to the end of treatment at 6 months]
Вторичные конечные точки (1)
  • Incidence of Adverse Events associated with Treatment [Срок оценки: From first treatment until the end of treatment at 6 months]

Критерии участия

Критерии включения

  • Males aged 18-65
  • Norwood III to IV, vertex focused
  • Fitzpatrick skin type I to VI
  • Ability and willingness to comply with study protocol

Критерии исключения

  • Change in other hair treatments in 3 months prior to study enrollment.
  • Known uncontrolled health conditions.
  • History of hair or scalp disorders that could interfere with study results.
  • History of metabolic syndrome.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Advanced Dermatology & Cosmetic Surgery — Maitland
  • Advanced Dermatology & Cosmetic Surgery — Port Orange

Идентификаторы

NCT: NCT07637071 · XTSM-2026-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗