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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Shanghai, Kina
- L'OREAL R&I China
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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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Placebo komparator: 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.
|
|
Eksperimentell: 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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Placebo komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Instrumental Evaluation of Skin Tone, Elasticity, and Wrinkles
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Trans-epidermal water loss(TEWL)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ACR_EV_25-11289_01
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