Eficácia e Segurança de um Nutracêutico Bebível para a Queda de Cabelo em Doentes a Utilizar Agonistas dos Recetores GLP-1/GIP
Avaliação da Eficácia e Segurança de um Nutracêutico Bebível na Melhoria da Queda de Cabelo em Pacientes Tratados com Agonistas dos Recetores GLP-1/GIP: um Estudo Duplamente Cego, Randomizado 1:1, Controlado por Placebo.
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.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Madrid
-
Madrid, Madrid, Espanha, 28006
- Recrutamento
- Grupo Dermatologico Y Estetico Pedro Jaen S.A.
-
Contato:
- Leyre Malet, PhD
- Número de telefone: +34 617862464
- E-mail: info@icmrresearch.com
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Braço placebo
|
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. |
|
Experimental: Braço de Produto Ativo
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hair loss
Prazo: From baseline to Day 180.
|
• Patient Reported Outcome using the Hair Shedding Scale: will assess the degree of hair loss among participants. On the day of the visit, they will be shown an A4 sheet with six ranges: between 1 (minimal shedding) to 6 (copious hair shedding). Ref. Perera E and Sinclair R, 2017 |
From baseline to Day 180.
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hair loss
Prazo: From baseline to Day 180.
|
Comb and Wash Test: this test will quantify the number of fallen hairs (outcome number of shed hairs). It will be carried out after refraining from washing the hair for 48 hours and combing the hair for 24 hours. |
From baseline to Day 180.
|
|
Body composition
Prazo: From baseline to Day 180.
|
Body weight (Kg). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor |
From baseline to Day 180.
|
|
Body composition
Prazo: From baseline to Day 180.
|
BMI (Kg/m2). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor |
From baseline to Day 180.
|
|
Body composition
Prazo: From baseline to Day 180.
|
Fat mass and fat-free mass percentages. Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor |
From baseline to Day 180.
|
|
Serum iron level
Prazo: From baseline to Day 180.
|
Serum iron concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Ferritin level
Prazo: From baseline to Day 180.
|
Serum ferritin concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Transferrin level
Prazo: From baseline to Day 180.
|
Serum transferrin concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Transferrin saturation
Prazo: From baseline to Day 180.
|
Transferrin saturation percentage calculated from iron metabolism parameters obtained from blood samples. |
From baseline to Day 180.
|
|
Serum zinc level
Prazo: From baseline to Day 180.
|
Serum zinc concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
25-hydroxyvitamin D level
Prazo: From baseline to Day 180.
|
Serum 25-hydroxyvitamin D concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Serum folate level
Prazo: From baseline to Day 180.
|
Serum folate concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Vitamin B12 level
Prazo: From baseline to Day 180.
|
Serum vitamin B12 concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Serum albumin level
Prazo: From baseline to Day 180.
|
Serum albumin concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Thyroid-stimulating hormone (TSH) level
Prazo: From baseline to Day 180.
|
Serum thyroid-stimulating hormone concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Free thyroxine (free T4) level
Prazo: From baseline to Day 180.
|
Serum free thyroxine concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Total testosterone level
Prazo: From baseline to Day 180.
|
Serum total testosterone concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Free testosterone level
Prazo: From baseline to Day 180.
|
Serum free testosterone concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Dehydroepiandrosterone sulfate (DHEA-S) level
Prazo: From baseline to Day 180.
|
Serum dehydroepiandrosterone sulfate concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Sex hormone-binding globulin (SHBG) level
Prazo: From baseline to Day 180.
|
Serum sex hormone-binding globulin concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Fasting glucose level
Prazo: From baseline to Day 180.
|
Fasting blood glucose concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Glycated hemoglobin (HbA1c)
Prazo: From baseline to Day 180.
|
Glycated hemoglobin measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Fasting insulin level
Prazo: From baseline to Day 180.
|
Fasting serum insulin concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
HOMA-IR
Prazo: From baseline to Day 180.
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin values. |
From baseline to Day 180.
|
|
Total cholesterol level
Prazo: From baseline to Day 180.
|
Total cholesterol concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
HDL cholesterol level
Prazo: From baseline to Day 180.
|
HDL cholesterol concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
LDL cholesterol level
Prazo: From baseline to Day 180.
|
LDL cholesterol concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Triglyceride level
Prazo: From baseline to Day 180.
|
Serum triglyceride concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Aspartate aminotransferase (AST) level
Prazo: From baseline to Day 180.
|
AST concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Alanine aminotransferase (ALT) level
Prazo: From baseline to Day 180.
|
ALT concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Gamma-glutamyl transferase (GGT) level
Prazo: From baseline to Day 180.
|
GGT concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Blood urea level
Prazo: From baseline to Day 180.
|
Blood urea concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
|
Serum creatinine level
Prazo: From baseline to Day 180.
|
Serum creatinine concentration measured in blood samples using standard clinical laboratory methods. |
From baseline to Day 180.
|
Outras medidas de resultado
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-assessment questionnaire
Prazo: From baseline to Day 180.
|
Subject-reported perception of hair condition assessed using a 12-item questionnaire covering perceived hair density, hair shedding, hair strength, hair volume, appearance, and scalp condition. Each item is rated on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate greater perceived improvement in hair and scalp condition. |
From baseline to Day 180.
|
|
Food consumption frequency questionnaire (PREDIMED questionnaire)
Prazo: From baseline to Day 180.
|
Adherence to the Mediterranean diet assessed using the validated 14-item PREDIMED (Prevención con Dieta Mediterránea) questionnaire. The questionnaire evaluates the frequency of consumption of key food groups and dietary habits characteristic of the Mediterranean diet, including olive oil use, fruit and vegetable intake, legumes, fish, nuts, red meat, sugary beverages, commercial pastries, and wine consumption. Each item is scored 0 or 1, resulting in a total score ranging from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet. |
From baseline to Day 180.
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- CT-ON-04
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .