プレミアム リバイタライジング エリクサーの頭皮ケア効果評価
プレミアムリバイタライジングエリクサーの頭皮スキンケア効果の評価
The study aims to evaluate the efficacy of the Premium Revitalizing Elixir on human scalp skin. A total of 60 healthy adults, aged 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning will be recruited and randomly assigned into five groups receiving different formulations. Participants will use the product once daily for 56 days, and their scalp conditions will be assessed through skin texture tests at multiple time points. Key parameters such as sebum content, overall hair loss, hair density, scalp condition, and hair length will be measured. A self-assessment and assessment by a hair specialist on hair and scalp condition will also be provided at the end of the study (Day 56).
調査の概要
状態
詳細な説明
This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.
This study aims to enroll 60 healthy adults aged from 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning.
Inclusion criteria include healthy adults defined as individuals without chronic diseases, significant illnesses (including cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant), or allergic constitutions, and who are not currently taking any medication or using any scalp care products.
Exclusion criteria include individuals who are pregnant or breastfeeding, as well as males or females with chronic diseases, significant illnesses, or allergic constitutions, currently using scalp care products, students or employees affiliated with the principal investigator, individuals with scalp wounds, those who have participated in cosmetic product testing, and those who have undergone scalp aesthetic treatments within the past three months.
The participants will be randomly assigned into five groups, with 12 individuals in each group. Group 1 uses Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with 0.1% caffeine and panthenol); Group 3 uses Base + IGF-1 & FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles; Group 5 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles + IGF-1 & FGF-7 (each growth factor at twice the concentration than that in Group 3). Before using the test product, all 60 participants undergo the first scalp skin texture test. After 14 days of using the test product, a second scalp skin texture test is conducted; after 28 days of use, a third test is performed; after 42 days of use, a fourth test is conducted; and after 56 days of use, a fifth test is carried out. The scalp skin texture tests include measurements of skin (1) sebum content, (2) overall hair loss, (3) hair density, (4) scalp condition, (5) hair length, and other parameters. The Sebumeter® SM815 probe of the MPA580 device and the ScalpX Intelligent Scalp Diagnostic System will be used to measure the parameters of the study. On Day 56, the participants will be asked to fill out a self-assessment form and a hair specialist will also assess the hair and scalp condition at the end of the study.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Taichung、台湾、433304
- Hungkuang University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy adults of any gender from the age of 18 to 60 years (inclusive).
- Having symptoms of alopecia, baldness, or self-identified with hair thinning.
- Absence of chronic diseases, major illnesses, or allergies.
- Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant
Exclusion Criteria:
- Currently taking any medication or using any scalp care products
- Pregnant or breastfeeding
- Chronic diseases, significant illnesses, or allergic constitutions
- Currently using scalp care products
- Students or employees affiliated with the principal investigator,
- Individuals with scalp wounds
- Participated in cosmetic product testing
- Undergone scalp aesthetic treatments within the past three months.
研究計画
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Group 1: Placebo control
Base formula without caffeine and panthenol |
Placebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
|
実験的：Group 2: Base formula only
Base formula consisting of active ingredients 0.1% caffeine and panthenol (vitamin B5). |
Base formula consisting of active ingredients 0.1% caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
|
実験的：Group 3: Base formula plus IGF-1 & FGF-7.
Base formula plus insulin growth factor-1 (IGF-1, 250 ng/mL) and fibroblast growth factor-7 (FGF-7, 150 ng/mL) |
Base formula plus insulin growth factor-1 (IGF-1, 250 ng/mL) and fibroblast growth factor-7 (FGF-7, 150 ng/mL). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
|
実験的：Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles (1E9 particles/mL) |
Base formula plus Centella asiatica and ginger extracellular vesicles (1E9 particles/mL). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
|
実験的：Group 5: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7.
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles (both 1E9 particles/mL), insulin growth factor-1 (IGF-1, 500 ng/mL) and fibroblast growth factor-7 (FGF-7, 300 ng/mL) |
Base formula plus Centella asiatica and ginger extracellular vesicles (both 1E9 particles/mL), insulin growth factor-1 (IGF-1, 500 ng/mL) and fibroblast growth factor-7 (FGF-7, 300 ng/mL). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. |
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 |
|---|---|---|
|
Sebum Content
時間枠：Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
Assess oil levels on the scalp at standardized scalp sites (left, right, and vertex). Measured with C+K Multi Probe Adaptor MPA580 system using the Sebumeter® SM815 probe based on the grease spot photometry method with the sebum measurement cassette tape. |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
|
Hair length
時間枠：Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
Hair length (cm): Measured manually with ruler at standardized scalp sites (left, right, and vertex). |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
|
Hair density
時間枠：Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
Hair density (number of hairs/cm-square): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex). |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
|
Hair thickness
時間枠：Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex). |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
|
|
Hair loss
時間枠：Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
|
Hair loss: Assessed by the standardized hair combing test by counting the number of hairs shed after the participants' hair was combed over a clean surface for 60 strokes. |
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant self-assessment
時間枠：Day 56 (End of the study period)
|
Participants will be asked to fill out an assessment form with score from 0 to 4 for each of the hair and scalp condition evaluated. |
Day 56 (End of the study period)
|
|
Hair specialist assessment
時間枠：Day 56 (End of the study)
|
A hair specialist will assess the hair and scalp condition of the participant and assign a score from 0 to 4 for each of the evaluated items as well as assign a score of Global Aesthetic Improvement Scale (GAIS) from -1 to 3. |
Day 56 (End of the study)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-090-A
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
米国FDA規制機器製品の研究
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