Effects of Oral Collagen Drinks on Human Skin
8. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
105
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Beijing, Kina
- Beijing Ewish Testing Technology Co.,ltd.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The change of collagen fiber fluorescence intensity
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The change of skin elasticity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The change of skin brightness (L*)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: YAO PAN, Beijing Ewish Testing Technology Co.,ltd.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. mai 2026
Primær fullføring (Faktiske)
15. juni 2026
Studiet fullført (Faktiske)
30. juni 2026
Datoer for studieregistrering
Først innsendt
8. mai 2026
Først innsendt som oppfylte QC-kriteriene
18. mai 2026
Først lagt ut (Faktiske)
26. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SECCR2025-254
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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