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Effects of Oral Collagen Drinks on Human Skin

18. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

99

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
      • Beijing, China
        • Rekrutierung
        • Beijing Ewish Testing Technology Co.,ltd.
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Collagen Drink
oral intake 5 g collagen daily
Nahrungsergänzungsmittel: Collagen Drink
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)
Nahrungsergänzungsmittel: 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)
Experimental: MAXI Collagen Drink_High dose
oral intake 30 mL MAXI collagen daily (equivalent to 10 g of deep hydrolyzed collagen net weight)
Nahrungsergänzungsmittel: 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)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The change of collagen fiber fluorescence intensity
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The change of skin elasticity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The change of skin brightness (L*)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

TCI Co., Ltd.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Mai 2026

Primärer Abschluss (Geschätzt)

15. Juni 2026

Studienabschluss (Geschätzt)

30. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

8. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SECCR2025-254

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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