Study Evaluating Xtressé Gummy Supplement in Women With Self-Perceived Thinning Hair

Официальное название

Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement in Women With Self-Perceived Thinning Hair

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 women with self-perceived thinning hair. 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 5 visits after voluntary consent has been given. Participants will be given a 30-day supply of the gummies at each visit over a 4-month 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, and pregnancy test) * 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 female adult between 28 to 65 years of age * Have consistent self-perceived thinning hair. * 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 * Not be pregnant or breast feeding before and during the study and agree to use acceptable forms of birth control * 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.

Первичные конечные точки

• Hair Density Changes measured by SOCAi [Срок оценки: From enrollment to the end of the study at 4 months]
• Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis [Срок оценки: From enrollment to the end of treatment at 4 months]
• Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis [Срок оценки: From enrollment to the end of treatment at 4 months]

Вторичные конечные точки (1)

• Incidence of Adverse Events associated with Treatment [Срок оценки: From first treatment until the end of treatment at 4 months]

Критерии участия

Критерии включения

• Women aged 18-65 years with self-perceived thinning hair (confirmed by an investigator).
• Fitzpatrick skin types I to VI.
• Ability and willingness to comply with the study protocol.
• Commitment to using effective contraception throughout the study if of childbearing potential.

Критерии исключения

• Pregnancy, nursing, or recent initiation of hormone therapy.
• Change in other hair treatments within 3 months prior to the study.
• Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).
• 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 · 4 центра

• Advanced Dermatology & Cosmetic Surgery — Maitland
• Hair Medicine Institute — Alpharetta
• Kindred Hair and Skin — Marriottsville
• Root Hair Institute — Bellevue

Идентификаторы

NCT: NCT07224555 · XTS-2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗