Efficacy and Safety of a Drinkable Nutraceutical for Hair Loss in Patients Using GLP-1/GIP Receptor Agonists

Официальное название

Evaluation of the Efficacy and Safety of a Drinkable Nutraceutical in Improving Hair Loss in Patients Treated With GLP-1/GIP Receptor Agonists: a Double-blind, 1:1 Randomized, Placebo-controlled Study.

Обзор

The purpose of this clinical trial is to evaluate the efficacy of Olistic© Next Women, a nutraceutical supplement, compared with placebo in improving hair loss in patients undergoing treatment with GLP-1/GIP agonists. This 6-month, randomized, placebo-controlled clinical study investigates whether daily supplementation with Olistic© Next Women leads to significant improvements in hair loss in this patient population. In addition, the study assesses the safety and tolerability of the product throughout the treatment period.

Вмешательства

• Пищевая добавка Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +45.
  Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, amino acids, plant extracts, and other bioactive compounds designed to support hair growth and scalp health in women +45.
• Другое Placebo control
  Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile.

Первичные конечные точки

• Hair loss [Срок оценки: From baseline to Day 180.]

Вторичные конечные точки (12)

• Hair loss [Срок оценки: From baseline to Day 180.]
• Body composition [Срок оценки: From baseline to Day 180.]
• Body composition [Срок оценки: From baseline to Day 180.]
• Body composition [Срок оценки: From baseline to Day 180.]
• Serum iron level [Срок оценки: From baseline to Day 180.]
• Ferritin level [Срок оценки: From baseline to Day 180.]
• Transferrin level [Срок оценки: From baseline to Day 180.]
• Transferrin saturation [Срок оценки: From baseline to Day 180.]
• Serum zinc level [Срок оценки: From baseline to Day 180.]
• 25-hydroxyvitamin D level [Срок оценки: From baseline to Day 180.]
• Serum folate level [Срок оценки: From baseline to Day 180.]
• Vitamin B12 level [Срок оценки: From baseline to Day 180.]

Критерии участия

Критерии включения

• Female gender.
• Age >35 years.
• Initiation of treatment with a GLP-1/GIP agonist, or treatment duration < 3 months, as per routine clinical practice in the endocrinology clinic.
• Having signed the participant information sheet and the written informed consent and having been informed of the objective of the study.
• Additional criteria to be included by the client.

Критерии исключения

• Allergy or hypersensitivity to any of the components of the product, or to a product from a similar category to the one being tested.
• Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate to severe seborrheic dermatitis, eczema, cancer, etc.
• Women presenting alopecia due to an underlying medical condition (hypothyroidism, anemia, lupus, etc.).
• Pharmacological treatment that may promote the onset of telogen effluvium, initiated within the 3 months prior to study start (e.g., valproic acid, carbamazepine, phenytoin, selective serotonin reuptake inhibitors, oral anticoagulants, retinoids, beta-blockers). Patients who have undergone a dose change of these medications within the same period are also excluded.
• Women with uncontrolled thyroid disorders (hyperthyroidism or hypothyroidism) within the 6 months prior to study initiation.
• Women who have used anti-hair loss products within the last 3 months.
• Women who have initiated or undergone dermatological treatment for hair loss within the last 6 months (minoxidil, finasteride, PRP, mesotherapy, etc.).
• Women who have undergone hair transplantation within the 18 months prior to study initiation.
• Women who have initiated treatment with anxiolytics, antidepressants, amphetamines, ACE inhibitors, or iron within the last 3 months.
• Women who initiated or discontinued hormonal treatment (oral contraceptives, oral or topical hormone replacement therapy, ovarian stimulation) within the 3 months prior to study initiation.
• Pregnant women, postpartum women (within 6 months), breastfeeding women, or women planning to become pregnant during the study period.
• Additional exclusion criteria to be specified by the sponsor.
• Any condition that, in the investigator's opinion, makes participation in the study inappropriate.

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

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Grupo Dermatologico Y Estetico Pedro Jaen S.A. — Madrid

Публикации

• Perera E, Sinclair R. Treatment of chronic telogen effluvium with oral minoxidil: A retrospective study. F1000Res. 2017 Sep 6;6:1650. doi: 10.12688/f1000research.11775.1. eCollection 2017. PMID 29167734

Идентификаторы

NCT: NCT07484061 · CT-ON-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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