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Effects of Oral Collagen Drinks on Human Skin

18. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

99

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina
        • Rekruttering
        • Beijing Ewish Testing Technology Co.,ltd.
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Collagen Drink
oral intake 5 g collagen daily
Kosttilskud: Collagen Drink
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 5 g Collagen Powder
Eksperimentel: MAXI Collagen Drink
oral intake 15 mL MAXI collagen daily (equivalent to 5 g of deep hydrolyzed collagen net weight)
Kosttilskud: MAXI Collagen Drink
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)
Eksperimentel: MAXI Collagen Drink_High dose
oral intake 30 mL MAXI collagen daily (equivalent to 10 g of deep hydrolyzed collagen net weight)
Kosttilskud: MAXI Collagen Drink_High dose
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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change of collagen fiber fluorescence intensity
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change of skin elasticity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change of skin brightness (L*)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

TCI Co., Ltd.

Efterforskere

  • Ledende efterforsker: YAO PAN, Beijing Ewish Testing Technology Co.,ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. maj 2026

Primær færdiggørelse (Anslået)

15. juni 2026

Studieafslutning (Anslået)

30. juni 2026

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SECCR2025-254

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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