- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07605871
Effects of Oral Collagen Drinks on Human Skin
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ping Lin
- Numer telefonu: +886-02-87977811
- E-mail: candice.lin@tci-bio.com
Lokalizacje studiów
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Beijing, Chiny
- Rekrutacyjny
- Beijing Ewish Testing Technology Co.,ltd.
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Kontakt:
- PAN YAO
- Numer telefonu: +86-13522777985
- E-mail: Panyao@btbu.edu.cn
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny 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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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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The change of collagen fiber fluorescence intensity
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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The change of skin elasticity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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The change of skin brightness (L*)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: YAO PAN, Beijing Ewish Testing Technology Co.,ltd.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SECCR2025-254
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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