- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07605871
Effects of Oral Collagen Drinks on Human Skin
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Beijing, Kina
- Beijing Ewish Testing Technology Co.,ltd.
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Collagen Drink
oral intake 5 g collagen daily
|
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 5 g Collagen Powder
|
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Experimentell: MAXI Collagen Drink
oral intake 15 mL MAXI collagen daily (equivalent to 5 g of deep hydrolyzed collagen net weight)
|
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)
|
|
Experimentell: MAXI Collagen Drink_High dose
oral intake 30 mL MAXI collagen daily (equivalent to 10 g of deep hydrolyzed collagen net weight)
|
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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change of collagen fiber fluorescence intensity
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change of skin elasticity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
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The change of the Dermal-Epidermal Junction (DEJ) structures
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Change from Baseline crow's feet parameters at 4 weeks
|
|
The change of crow's feet depth
Tidsram: 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.
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Change from Baseline crow's feet parameters at 4 weeks
|
|
The change of the volume of fine lines under the eyes
Tidsram: Change from Baseline fine lines at 4 weeks
|
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
Tidsram: 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.
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Change from Baseline fine lines at 4 weeks
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The change of cheek (malar) volume
Tidsram: 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
|
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The change of jawline length
Tidsram: 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
Tidsram: Change from Baseline pore parameters at 4 weeks
|
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
|
|
The change of skin pores volume
Tidsram: Change from Baseline pore parameters at 4 weeks
|
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
Tidsram: 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.
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Change from Baseline skin hydration at 4 weeks
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The change of transepidermal water loss (TEWL)
Tidsram: 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.
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Change from Baseline TEWL at 4 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change of skin brightness (L*)
Tidsram: 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)
Tidsram: 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
Tidsram: Change from Baseline skin redness (a*) at 4 weeks
|
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
Tidsram: 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
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: YAO PAN, Beijing Ewish Testing Technology Co.,ltd.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SECCR2025-254
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