Effects of Oral Collagen Drinks on Human Skin
8 de julho de 2026 atualizado por: TCI Co., Ltd.
The objective of this study is to evaluate the effect of oral collagen drink and MAXI collagen drink on human skin condition improvement.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This study is a single-center, double-blinded, parallel human trial designed to evaluate the skin beauty effect of oral collagen drink and MAXI collagen drink.
Healthy adult participants aged 18-60 years will be enrolled. Participants will be informed to consume test samples daily for 4 consecutive weeks. Skin measurement and self-assessment questionnaires will be conducted at baseline (before intake), after 1 week, and 4 weeks of consumption.
Tipo de estudo
Intervencional
Inscrição (Real)
105
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.
Locais de estudo
-
-
-
Beijing, China
- Beijing Ewish Testing Technology Co.,ltd.
-
-
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
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Healthy Chinese subjects aged 18 to 60 years, both male and female.
- Wrinkle Severity: Crow's feet graded 2-4; under-eye fine lines graded 2-5; nasolabial folds graded 1-3.
- Presence of facial skin laxity and sagging.
- Ability to undergo skin examinations and pre-treatment in the designated test areas.
- Ability to understand the trial process, participate voluntarily, and sign a written Informed Consent Form (ICF).
Exclusion Criteria:
- Pregnant or lactating women, or those planning to become pregnant in the near future.
- Highly sensitive constitution, history of allergic diseases, or history of allergies to cosmetics.
- Presence of skin diseases (e.g., psoriasis, eczema, atopic dermatitis, severe acne) or other chronic systemic diseases.
- Skin conditions in the test area such as birthmarks, hyperpigmentation, inflammation, scars, nevi (moles), or hypertrichosis (excessive hair).
- Use of anti-inflammatory drugs (e.g., oral or topical corticosteroids) within the past month.
- Use of cosmetics or other products with similar efficacy within the past 2 weeks.
- Participation in other human clinical trials for cosmetics within the past month.
- Any other conditions deemed unsuitable for participation based on clinical assessment.
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Collagen Drink
oral intake 5 g collagen daily
|
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 5 g Collagen Powder
|
|
Experimental: MAXI Collagen Drink
oral intake 15 mL MAXI collagen daily (equivalent to 5 g of deep hydrolyzed collagen net weight)
|
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 15 mL MAXI Collagen Liquid (equivalent to 5 g of deep hydrolyzed collagen net weight)
|
|
Experimental: MAXI Collagen Drink_High dose
oral intake 30 mL MAXI collagen daily (equivalent to 10 g of deep hydrolyzed collagen net weight)
|
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 30 mL MAXI Collagen Liquid (equivalent to 10 g of deep hydrolyzed collagen net weight)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The change of collagen fiber fluorescence intensity
Prazo: Change from Baseline collagen intensity at 4 weeks
|
SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to evaluate the density and quality of dermal collagen fibers.
|
Change from Baseline collagen intensity at 4 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The change of skin elasticity
Prazo: Change from Baseline skin elasticity at 4 weeks
|
Cutometer® MPA580 (CK, Germany) was utilized to measure the gross elasticity of the skin using suction method.
|
Change from Baseline skin elasticity at 4 weeks
|
|
The change of skin firmness
Prazo: Change from Baseline skin firmness at 4 weeks
|
Cutometer® MPA580 (CK, Germany) was utilized to measure skin firmness and the area under the suction curve.
|
Change from Baseline skin firmness at 4 weeks
|
|
The change of epidermal thickness
Prazo: Change from Baseline epidermal thickness at 4 weeks
|
SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to measure the depth of the epidermal layer using optical imaging.
|
Change from Baseline epidermal thickness at 4 weeks
|
|
The change of cheek skin roughness
Prazo: Change from Baseline skin roughness at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the arithmetic average roughness (Ra value) of the cheek surface.
|
Change from Baseline skin roughness at 4 weeks
|
|
The change of the Dermal-Epidermal Junction (DEJ) structures
Prazo: Change from Baseline DEJ status at 4 weeks
|
SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to assess the structural integrity and epithelial-connective tissue interface (ECTI) of the DEJ.
|
Change from Baseline DEJ status at 4 weeks
|
|
The change of nasolabial folds volume
Prazo: Change from Baseline wrinkle parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to quantify the 3D morphological changes of the nasolabial folds volume.
|
Change from Baseline wrinkle parameters at 4 weeks
|
|
The change of nasolabial folds depth
Prazo: Change from Baseline wrinkle parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to quantify the 3D morphological changes of the nasolabial folds depth.
|
Change from Baseline wrinkle parameters at 4 weeks
|
|
The change of crow's feet volume
Prazo: Change from Baseline crow's feet parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the severity of crow's feet volume.
|
Change from Baseline crow's feet parameters at 4 weeks
|
|
The change of crow's feet depth
Prazo: Change from Baseline crow's feet parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the severity of crow's feet depth.
|
Change from Baseline crow's feet parameters at 4 weeks
|
|
The change of the volume of fine lines under the eyes
Prazo: Change from Baseline fine lines at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to assess the volume of fine lines under the eyes.
|
Change from Baseline fine lines at 4 weeks
|
|
The change of the mean depth of fine lines under the eyes
Prazo: Change from Baseline fine lines at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to assess the mean depth of fine lines under the eyes.
|
Change from Baseline fine lines at 4 weeks
|
|
The change of cheek (malar) volume
Prazo: Change from Baseline cheek volume at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the 3D volume of the cheek area for lifting effects.
|
Change from Baseline cheek volume at 4 weeks
|
|
The change of jawline length
Prazo: Change from Baseline jawline parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the linear length and contour of the jawline.
|
Change from Baseline jawline parameters at 4 weeks
|
|
The change of skin pores counts
Prazo: Change from Baseline pore parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to perform 3D imaging and quantification of skin pores counts.
|
Change from Baseline pore parameters at 4 weeks
|
|
The change of skin pores volume
Prazo: Change from Baseline pore parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to perform 3D imaging and quantification of skin pores volume.
|
Change from Baseline pore parameters at 4 weeks
|
|
The change of skin hydration
Prazo: Change from Baseline skin hydration at 4 weeks
|
Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydration.
Units: arbitrary Corneometer® units 0-120.
|
Change from Baseline skin hydration at 4 weeks
|
|
The change of transepidermal water loss (TEWL)
Prazo: Change from Baseline TEWL at 4 weeks
|
Tewameter® TM300 (CK, Germany) was utilized to measure the evaporation rate of water from the skin.
Units: g/h/m^2.
|
Change from Baseline TEWL at 4 weeks
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The change of skin brightness (L*)
Prazo: Change from Baseline skin brightness (L*) at 4 weeks
|
Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin brightness (L*).
|
Change from Baseline skin brightness (L*) at 4 weeks
|
|
The change of skin individual typology angle (ITA)
Prazo: Change from Baseline skin ITA at 4 weeks
|
Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin individual typology angle (ITA).
|
Change from Baseline skin ITA at 4 weeks
|
|
The change of skin color parameters
Prazo: Change from Baseline skin redness (a*) at 4 weeks
|
Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin redness (a*).
|
Change from Baseline skin redness (a*) at 4 weeks
|
|
The change of skin color parameters
Prazo: Change from Baseline skin yellow tone (b*) at 4 weeks
|
Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin yellow tone (b*).
|
Change from Baseline skin yellow tone (b*) at 4 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: YAO PAN, Beijing Ewish Testing Technology Co.,ltd.
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 (Real)
12 de maio de 2026
Conclusão Primária (Real)
15 de junho de 2026
Conclusão do estudo (Real)
30 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
8 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de maio de 2026
Primeira postagem (Real)
26 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SECCR2025-254
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 .