Effects of Oral Collagen Drinks on Human Skin
8 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
105
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing, Porcelana
- Beijing Ewish Testing Technology Co.,ltd.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Collagen Drink
oral intake 5 g collagen daily
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consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 5 g Collagen Powder
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Experimental: MAXI Collagen Drink
oral intake 15 mL MAXI collagen daily (equivalent to 5 g of deep hydrolyzed collagen net weight)
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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)
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Experimental: MAXI Collagen Drink_High dose
oral intake 30 mL MAXI collagen daily (equivalent to 10 g of deep hydrolyzed collagen net weight)
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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)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The change of collagen fiber fluorescence intensity
Periodo de tiempo: Change from Baseline collagen intensity at 4 weeks
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SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to evaluate the density and quality of dermal collagen fibers.
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Change from Baseline collagen intensity at 4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The change of skin elasticity
Periodo de tiempo: Change from Baseline skin elasticity at 4 weeks
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Cutometer® MPA580 (CK, Germany) was utilized to measure the gross elasticity of the skin using suction method.
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Change from Baseline skin elasticity at 4 weeks
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The change of skin firmness
Periodo de tiempo: Change from Baseline skin firmness at 4 weeks
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Cutometer® MPA580 (CK, Germany) was utilized to measure skin firmness and the area under the suction curve.
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Change from Baseline skin firmness at 4 weeks
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The change of epidermal thickness
Periodo de tiempo: Change from Baseline epidermal thickness at 4 weeks
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SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to measure the depth of the epidermal layer using optical imaging.
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Change from Baseline epidermal thickness at 4 weeks
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The change of cheek skin roughness
Periodo de tiempo: Change from Baseline skin roughness at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to measure the arithmetic average roughness (Ra value) of the cheek surface.
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Change from Baseline skin roughness at 4 weeks
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The change of the Dermal-Epidermal Junction (DEJ) structures
Periodo de tiempo: Change from Baseline DEJ status at 4 weeks
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SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to assess the structural integrity and epithelial-connective tissue interface (ECTI) of the DEJ.
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Change from Baseline DEJ status at 4 weeks
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The change of nasolabial folds volume
Periodo de tiempo: Change from Baseline wrinkle parameters at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to quantify the 3D morphological changes of the nasolabial folds volume.
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Change from Baseline wrinkle parameters at 4 weeks
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The change of nasolabial folds depth
Periodo de tiempo: Change from Baseline wrinkle parameters at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to quantify the 3D morphological changes of the nasolabial folds depth.
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Change from Baseline wrinkle parameters at 4 weeks
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The change of crow's feet volume
Periodo de tiempo: Change from Baseline crow's feet parameters at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to measure the severity of crow's feet volume.
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Change from Baseline crow's feet parameters at 4 weeks
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The change of crow's feet depth
Periodo de tiempo: Change from Baseline crow's feet parameters at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to measure the severity of crow's feet depth.
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Change from Baseline crow's feet parameters at 4 weeks
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The change of the volume of fine lines under the eyes
Periodo de tiempo: Change from Baseline fine lines at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to assess the volume of fine lines under the eyes.
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Change from Baseline fine lines at 4 weeks
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The change of the mean depth of fine lines under the eyes
Periodo de tiempo: Change from Baseline fine lines at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to assess the mean depth of fine lines under the eyes.
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Change from Baseline fine lines at 4 weeks
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The change of cheek (malar) volume
Periodo de tiempo: Change from Baseline cheek volume at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to measure the 3D volume of the cheek area for lifting effects.
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Change from Baseline cheek volume at 4 weeks
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The change of jawline length
Periodo de tiempo: Change from Baseline jawline parameters at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to measure the linear length and contour of the jawline.
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Change from Baseline jawline parameters at 4 weeks
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The change of skin pores counts
Periodo de tiempo: Change from Baseline pore parameters at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to perform 3D imaging and quantification of skin pores counts.
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Change from Baseline pore parameters at 4 weeks
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The change of skin pores volume
Periodo de tiempo: Change from Baseline pore parameters at 4 weeks
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AEVA-HE (EOTECH, France) was utilized to perform 3D imaging and quantification of skin pores volume.
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Change from Baseline pore parameters at 4 weeks
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The change of skin hydration
Periodo de tiempo: Change from Baseline skin hydration at 4 weeks
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Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydration.
Units: arbitrary Corneometer® units 0-120.
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Change from Baseline skin hydration at 4 weeks
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The change of transepidermal water loss (TEWL)
Periodo de tiempo: Change from Baseline TEWL at 4 weeks
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Tewameter® TM300 (CK, Germany) was utilized to measure the evaporation rate of water from the skin.
Units: g/h/m^2.
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Change from Baseline TEWL at 4 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The change of skin brightness (L*)
Periodo de tiempo: Change from Baseline skin brightness (L*) at 4 weeks
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Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin brightness (L*).
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Change from Baseline skin brightness (L*) at 4 weeks
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The change of skin individual typology angle (ITA)
Periodo de tiempo: Change from Baseline skin ITA at 4 weeks
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Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin individual typology angle (ITA).
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Change from Baseline skin ITA at 4 weeks
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The change of skin color parameters
Periodo de tiempo: Change from Baseline skin redness (a*) at 4 weeks
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Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin redness (a*).
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Change from Baseline skin redness (a*) at 4 weeks
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The change of skin color parameters
Periodo de tiempo: Change from Baseline skin yellow tone (b*) at 4 weeks
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Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin yellow tone (b*).
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Change from Baseline skin yellow tone (b*) at 4 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: YAO PAN, Beijing Ewish Testing Technology Co.,ltd.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de mayo de 2026
Finalización primaria (Actual)
15 de junio de 2026
Finalización del estudio (Actual)
30 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SECCR2025-254
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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