Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Aging
Efficacy Evaluation of a Botanical Extract in Simple Skincare Formulations for Anti-Ageing: A Single Center, Double-Blinded, Placebo-Controlled, Randomized, Split-Face Study
Przegląd badań
Status
Warunki
Szczegółowy opis
This is a single-center, double-blinded, placebo-controlled, split-face, prospective clinical study designed to evaluate the anti-ageing efficacy and safety of a botanical extract. 66 subjects with dry skin on both sides of their faces were recruited. A split-face design is utilized in this study. Test products are applied topically twice daily for 56 days.
The primary objective is to assess the skin anti-ageing efficacy (instrumental evaluations including skin tone & wrinkles, and clinical gradings on signs of ageing) of the active botanical extract compared to a placebo. The secondary objective is to investigate potential mechanisms via untargeted proteomics.
Instrumental evaluations and clinical scorings are performed at Baseline, Day 28, and Day 56. Non-invasive D-Squame tape-stripping samplings for proteomics analysis are collected at Baseline and Day 56.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Shanghai, Chiny
- L'OREAL R&I China
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Chinese female subjects aged 35 to 60 years (inclusive) in good general health based on subjective self-report and investigator assessment.
- Fitzpatrick skin type II, III, or IV.
- Self-reported dry skin type.
- Meets specified skin criteria assessed by investigator: Crow's feet wrinkle grade between 3 and 5 (inclusive), with priority given to subjects with a side-to-side difference ≤ 0.5 in grade.
- Facial trans-epidermal water loss (TEWL) ≥ 6 g/m²·h as measured by Vapometer.
- Facial stratum corneum hydration level between 20 and 45 (inclusive) as measured by Corneometer.
- Willing to avoid excessive sun exposure throughout the study period.
- Females of childbearing potential (FCBP) must agree to use highly effective contraception methods or remain abstinent from 1 month prior to study start through study completion; or postmenopausal females.
- FCBP must have a negative urine pregnancy test at screening.
- Willing to undergo tape-stripping procedures for stratum corneum sampling.
- No other dermatological conditions deemed unsuitable for participation (e.g., facial tattoos, scars).
- Willing to sign Informed Consent Form (ICF) and Image Authorization Form.
- Able and willing to comply with all study procedures and visit schedules.
Exclusion Criteria:
- Current pregnancy, breastfeeding, or planning to become pregnant.
- Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products).
- History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.).
- Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis).
- Known allergies to cosmetics, personal care products, or their ingredients.
- Excessive UV exposure or frequent sauna/water sports usage.
- Use of antihistamines, antibiotics, corticosteroids, or NSAIDs within relevant washout periods.
- Participation in any other clinical trial within the past 30 days.
- Planned surgical or invasive procedures during the study period.
- Individuals deprived of liberty by judicial or administrative order.
- Subjects who cannot be reached by telephone in case of an emergency.
- Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Experimental: 0.05% Active Formulation
Formulation with 0.05% botanic extract
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Topical skincare formulation containing Botanical Extract (Concentration 1, 0.05%).
Applied topically twice daily for 56 days
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Komparator placebo: Placebo: Vehicle control 1
Applying the placebo formula without active ingredient
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Topical skincare formulation base (identical to Active Formulation 1 but without the active botanical extract).
Applied topically twice daily for 56 days.
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Eksperymentalny: Experimental: 0.14% Active Formulation
Formulation with 0.14% botanic extract
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Topical skincare formulation containing Botanical Extract (Concentration 2, 0.14%).
Applied topically twice daily for 56 days.
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Komparator placebo: Placebo: Vehicle Control 2
Applying the placebo formula without active ingredient
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Topical skincare formulation base (identical to Active Formulation 2 but without the active botanical extract).
Applied topically twice daily for 56 days.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Instrumental Evaluation of Skin Tone, Elasticity, and Wrinkles
Ramy czasowe: Baseline, Day 28, Day 56
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Evaluation of skin color/tone using Colorimeter (CL400), skin elasticity using Cutometer (MPA 580), and crow's feet wrinkles using PRIMOS CR (Canfield Scientific)
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Baseline, Day 28, Day 56
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Clinical Scoring of Facial Ageing Signs
Ramy czasowe: Baseline, Day 28, and Day 56
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Dermatological grading of crow's feet wrinkles, forehead wrinkles, fine lines on forehead, inter-ocular wrinkles, underneath eye wrinkles, visual smoothness, tactile smoothness, firmness, and skin elasticity using standard clinical visual/tactile grading scales. crow's feet(0-6, the higher the worse), forehead wrinkles(0-8, the higher the worse), fine lines on the forehead(0-7,the higher the worse), inter-ocular wrinkles(0-7, the higher the worse), underneath eye wrinkles(0-9, the higher the worse),smoothness(Visual)(0-9,the higher the worse), smoothness(tactile)(0-9,the higher the worse), firmness(0-9,the higher the worse), skin elasticity(0-9,the higher the worse) |
Baseline, Day 28, and Day 56
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Trans-epidermal water loss(TEWL)
Ramy czasowe: Baseline, Day 28, Day 56
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trans-epidermal water loss using Vapometer (Vapometer, Delfin)
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Baseline, Day 28, Day 56
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Skin Hydration Index
Ramy czasowe: Baseline, Day 28, Day 56
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Hydration Index using Corneometer(Corneometer CM 825, Courage-Khazaka)
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Baseline, Day 28, Day 56
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Epidermal Proteomic Profile Changes
Ramy czasowe: Baseline and Day 56
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Characterization and untargeted proteomics analysis of epidermal biomarkers obtained via non-invasive tape-stripping (D-Squame) sampling
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Baseline and Day 56
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
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
Inne numery identyfikacyjne badania
- ACR_EV_25-11289_01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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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