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O Efeito da Ingestão Dietética de 16 Semanas de Suplementos Alimentares Contendo Colagénio e MSM na Eritema Facial e Outros Parâmetros da Pele (TO-COSKIN4)

9 de novembro de 2026 atualizado por: VIST - Faculty of Applied Sciences

O Efeito da Ingestão Dietética de Suplementos Alimentares Contendo Colagénio e MSM Durante 16 Semanas na Eritema Facial e Outros Parâmetros da Pele: Estudo Duplamente Cego, Controlado por Placebo, Aleatório de Três Vias Comparando a Eficácia de Dois Produtos de Teste

The aim of this study is to compare the effects of 16 weeks of daily dietary supplementation with two investigational products containing collagen, methylsulfonylmethane (MSM), and vitamin C on skin parameters in comparison to a placebo product. The study will be conducted in healthy women aged 40 to 65 years with visible facial erythema and telangiectasiae (cheeks), stable for ≥3 months, without active rosacea. The primary objective is to demonstrate beneficial effects of the investigational products on facial erythema. The secondary objectives are to evaluate the effect on facial erythema after 8 weeks and the effects on telangiectasiae severity and other redness-related skin parameters. Other skin parameters will be assessed as supportive endpoints, and differences between the two investigational formulations will also be explored.

Visão geral do estudo

Descrição detalhada

This is a single-centre, randomized, double-blind, placebo-controlled, one-period effectiveness study designed to evaluate the effects of multiple-dose, daily dietary supplementation over a 16-week period on skin parameters in healthy women aged 40 to 65 years. The study population consists of subjects with visible facial erythema and telangiectasiae predominantly on the cheeks, stable for at least 3 months prior to inclusion, and without clinical signs of active rosacea.

Eligible participants will be randomized to receive one of two investigational products or a placebo product, administered as a daily oral dose of 30 mL for 16 consecutive weeks. The investigational products contain the following compositions: Investigational Product 1 (IP1): collagen 10 g, methylsulfonylmethane (MSM) 2.0 g, and vitamin C 160 mg; and Investigational Product 2 (IP2): collagen 5 g, MSM 1.5 g, and vitamin C 160 mg.

The primary objective of the study is to evaluate whether 16 weeks of supplementation with the investigational products results in a beneficial effect on facial erythema compared with placebo. The secondary objectives are to assess the effect on facial erythema after 8 weeks and the effects on telangiectasiae severity and other redness-related skin parameters. Supportive objectives include the evaluation of additional skin parameters; differences between the two investigational formulations will also be explored.

All participants also take part in a nested substudy (Part B), registered separately, assessing advanced glycation end products in the skin.

Tipo de estudo

Intervencional

Inscrição (Estimado)

90

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Janko Žmitek, PhD
  • Número de telefone: 0038612831700
  • E-mail: kozmetika@vist.si

Locais de estudo

    • Ljubljana
      • Ljubljana, Ljubljana, Eslovênia, 1000
        • Recrutamento
        • VIST - Faculty of Applied Sciences, Institute of Cosmetics
        • Contato:
        • Investigador principal:
          • Katja Žmitek, PhD
        • Subinvestigador:
          • Tina Pogačnik, MSc
        • Subinvestigador:
          • Petra Keršmanc, MSc
        • Subinvestigador:
          • Sara Jereb, MSc
        • Subinvestigador:
          • Manica Bevec, BSc

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Caucasian female volunteers aged 40 to 65 years at the time of signing the Informed Consent Form (ICF).
  • Signed ICF.
  • Fitzpatrick skin phototypes I-IV.
  • Presence of visible facial telangiectasias, primarily on the cheeks.
  • Presence of facial erythema with a baseline score <= 3 on the 5-point Clinician's Erythema Assessment (CEA) scale.
  • Stable erythema-prone facial skin for at least 3 months prior to inclusion, without clinical signs of active rosacea.
  • In good general health, as determined by medical history.
  • Body mass index (BMI) < 35.
  • Willingness and ability to comply with all study procedures and complete a subject diary; maintain usual lifestyle habits; not initiate or modify oestrogen or progesterone therapies; maintain the same cosmetic and skincare routine and comply with sun protection guidelines; avoid rejuvenation treatments; refrain from food supplements containing collagen or other protein-based supplements, MSM, or anti-inflammatory and/or antioxidant compounds with a known or potential impact on skin inflammation or vascular response; and refrain from shaving, waxing, epilating or otherwise removing hair from the forearms for the duration of the study.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Vegan diet.
  • Following a weight-loss diet or another special or restrictive diet (e.g. very-low-calorie, ketogenic or intermittent fasting), or planning to start one during the study.
  • Heavy smoking (more than 20 cigarettes per day) or frequent alcohol-induced flushing.
  • Occupational or hobby-related excessive heat exposure (e.g. chefs, sauna workers).
  • Anticipated sunbathing or solarium use, or major planned changes in sun exposure before or during the study.
  • Planned major changes during the study in skincare routine or hormonal therapy (contraception or hormone replacement therapy).
  • Significant changes in dietary habits or dietary supplementation within 3 months prior to inclusion.
  • Regular use within 3 months prior to inclusion of food supplements containing MSM, collagen or other protein-based supplements, or anti-inflammatory (e.g. bioflavonoids/rutin, curcumin, EPA) and/or antioxidant supplements with a known or potential impact on skin inflammation or vascular response.
  • Any diagnosed, uncontrolled, untreated or unstable medical condition.
  • Clinically significant history of metabolic, gastrointestinal, hepatic, renal or haematological disease.
  • Diagnosed diabetes mellitus (type 1 or type 2), or current use of glucose-lowering medication.
  • Current use, or use within 12 months prior to study entry, of medicines for weight reduction, including GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists, or planned use during the study.
  • Mental incapacity or psychiatric condition that may impair understanding of the study or compliance with study requirements.
  • Any clinically significant acute or chronic inflammatory skin disease (e.g. acne, perioral dermatitis, psoriasis, atopic dermatitis, lupus).
  • Skin pigmentation disorders at the assessment sites.
  • Active rosacea within 3 months prior to study entry (papules/pustules, frequent flushing episodes typical of rosacea, or ocular involvement).
  • Frequent vasomotor hot flushes (e.g. perimenopausal or menopausal).
  • Use of medications affecting skin or vascular reactivity (e.g. systemic corticosteroids, anticoagulants, vasodilators, antibiotics known to affect vascular response, immunomodulators, regular or long-term use of NSAIDs).
  • Use of systemic retinoids within 3 months prior to study entry.
  • Changes of skincare routine within 4 weeks prior to study entry.
  • Use of highly concentrated topical products affecting inflammatory or vascular facial responses (e.g. >15% azelaic acid, 10% vitamin C) within 4 weeks prior to study entry.
  • Invasive rejuvenation treatments (e.g. medium or deep chemical peels, ablative or vascular laser therapies) within 6 months prior to study entry.
  • Non-invasive or minimally invasive rejuvenation treatments (e.g. microneedling, mesotherapy, superficial chemical peels, radiofrequency, electrotherapy, ultrasound, IPL) within 3 months prior to study entry.
  • Tattoos, scars, birthmarks, pronounced hyperpigmentation, visible vessels, or an active skin lesion or skin disease at the volar forearm of both forearms.
  • Self-tanning products applied to the forearms, or deliberate UV exposure of the forearms (sunbathing, solarium), within 4 weeks before the first visit.
  • Known or suspected allergy to any ingredient of the investigational products.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: IP1 group

Participants will receive investigational product 1 containing collagen (10 g/ 30 mL), MSM (2.0 g/ 30 mL) and vitamin C (160 mg/ 30 mL) for 16 weeks.

Participants will test continuous administration of investigational product for 16 weeks.

Outros nomes:
  • Produto investigacional 1
Comparador Ativo: IP2 group

Participants will receive investigational product 2 containing collagen (5 g/ 30 mL), MSM (1.5 g/ 30 mL) and vitamin C (160 mg/ 30 mL) for 16 weeks.

Participants will test continuous administration of the investigational product for 16 weeks.

Outros nomes:
  • Produto investigacional 2
Comparador de Placebo: Placebo group

Placebo group participants will receive placebo syrup without active ingredients (0 mg of collagen, 0 mg of MSM and 0 mg of vitamin C), 30 mL/daily for 16 weeks.

Participants will test continuous administration of placebo product for 16 weeks.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in facial erythema (redness - average) from baseline to week 16
Prazo: From baseline to end of intervention at 16 weeks

Redness - average in arbitrary units (a.u.), Antera 3D CS multispectral imaging; each investigational product compared with placebo.

From baseline to end of intervention at 16 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in haemoglobin hyper-concentration from baseline to week 16
Prazo: From baseline to end of intervention at 16 weeks

Haemoglobin hyper-concentration (a.u.), Antera 3D CS, as a measure of facial telangiectasiae severity; each investigational product compared with placebo; also assessed at week 8.

From baseline to end of intervention at 16 weeks
Change in redness - variation from baseline to week 16
Prazo: From baseline to end of intervention at 16 weeks

Redness - variation (a.u.), Antera 3D CS, as a measure of the variability (unevenness) of facial redness; also assessed at week 8.

From baseline to end of intervention at 16 weeks
Change in skin colour (delta a*) from baseline to week 16
Prazo: From baseline to end of intervention at 16 weeks

Delta a* (CIELAB red-green axis), Antera 3D CS

From baseline to end of intervention at 16 weeks

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in dermis density from baseline to week 16
Prazo: From baseline to end of intervention at 16 weeks

Dermis intensity (0-100), 20 MHz ultrasonography (Cortex DermaLab), volar forearm

From baseline to end of intervention at 16 weeks
Change in dermis thickness from baseline to week 16
Prazo: From baseline to end of intervention at 16 weeks

Dermis thickness (µm), 20 MHz ultrasonography (Cortex DermaLab), volar forearm;

From baseline to end of intervention at 16 weeks
Change in skin elasticity (R2) from baseline to week 16
Prazo: From baseline to end of intervention at 16 weeks

Skin elasticity parameter R2, volar forearm measured with Cortex DermaLab

From baseline to end of intervention at 16 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Diretor de estudo: Katja Žmitek, PhD, Head of Reasearch Group

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

16 de novembro de 2026

Conclusão Primária (Estimado)

30 de junho de 2027

Conclusão do estudo (Estimado)

1 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de janeiro de 2026

Primeira postagem (Real)

15 de janeiro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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