Effects of Oral Collagen Drinks on Human Skin
2026年7月8日 更新者：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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
105
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Beijing、中国
- Beijing Ewish Testing Technology Co.,ltd.
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The change of collagen fiber fluorescence intensity
時間枠：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.
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Change from Baseline collagen intensity at 4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The change of skin elasticity
時間枠：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.
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Change from Baseline skin elasticity at 4 weeks
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The change of skin firmness
時間枠：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
|
|
The change of epidermal thickness
時間枠：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
時間枠：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
時間枠：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.
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Change from Baseline DEJ status at 4 weeks
|
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The change of nasolabial folds volume
時間枠：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.
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Change from Baseline wrinkle parameters at 4 weeks
|
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The change of nasolabial folds depth
時間枠：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.
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Change from Baseline wrinkle parameters at 4 weeks
|
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The change of crow's feet volume
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The change of skin brightness (L*)
時間枠：Change from Baseline skin brightness (L*) at 4 weeks
|
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)
時間枠：Change from Baseline skin ITA at 4 weeks
|
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
時間枠：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
時間枠：Change from Baseline skin yellow tone (b*) at 4 weeks
|
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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：YAO PAN、Beijing Ewish Testing Technology Co.,ltd.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月12日
一次修了 (実際)
2026年6月15日
研究の完了 (実際)
2026年6月30日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月10日
QC基準を満たした最後の更新が送信されました
2026年7月8日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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