Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Aging

N/AActive Not RecruitingNCT07780799

L'Oreal66 enrolled

Overview

This is a single-center, double-blinded, placebo-controlled, split-face, prospective clinical study to evaluate the anti-ageing efficacy and safety of a topical cosmetic formulation containing a botanical extract. 66 female subjects with dry skin were recruited. The study compares the anti-ageing benefits of a formula containing the botanical active extract versus a placebo over a 8-week application period.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Aging Dry Skin

Interventions

Cosmetic Topical Formulation 1OTHER

Topical skincare formulation containing Botanical Extract (Concentration 1, 0.05%). Applied topically twice daily for 56 days

Cosmetic Base of Topical Formulation 1OTHER

Topical skincare formulation base (identical to Active Formulation 1 but without the active botanical extract). Applied topically twice daily for 56 days.

Cosmetic Topical Formulation 2OTHER

Topical skincare formulation containing Botanical Extract (Concentration 2, 0.14%). Applied topically twice daily for 56 days.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Chinese female subjects aged 35 to 60 years (inclusive) in good general health based on subjective self-report and investigator assessment. 2. Fitzpatrick skin type II, III, or IV. 3. Self-reported dry skin type. 4. 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. 5. Facial trans-epidermal water loss (TEWL) ≥ 6 g/m²·h as measured by Vapometer. 6. Facial stratum corneum hydration level between 20 and 45 (inclusive) as measured by Corneometer. 7. Willing to avoid excessive sun exposure throughout the study period. 8. 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. 9. FCBP must have a negative urine pregnancy test at screening. 10. Willing to undergo tape-stripping procedures for stratum corneum sampling. 11. No other dermatological conditions deemed unsuitable for participation (e.g., facial tattoos, scars). 12. Willing to sign Informed Consent Form (ICF) and Image Authorization Form. 13. Able and willing to comply with all study procedures and visit schedules. Exclusion Criteria: 1. Current pregnancy, breastfeeding, or planning to become pregnant. 2. Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products). 3. History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.). 4. Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis). 5. Known allergies to cosmetics, personal care products, or their ingredients. 6. Excessive UV exposure or frequent sauna/water sports usage. 7. Use of antihistamines, antibiotics, corticosteroids, or NSAIDs within relevant washout periods. 8. Participation in any other clinical trial within the past 30 days. 9. Planned surgical or invasive procedures during the study period. 10. Individuals deprived of liberty by judicial or administrative order. 11. Subjects who cannot be reached by telephone in case of an emergency. 12. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation.

Locations (1)

L'OREAL R&I China

Shanghai, China

Outcomes

Primary Outcomes

Instrumental Evaluation of Skin Tone, Elasticity, and Wrinkles

Evaluation of skin color/tone using Colorimeter (CL400), skin elasticity using Cutometer (MPA 580), and crow's feet wrinkles using PRIMOS CR (Canfield Scientific)

Time frame: Baseline, Day 28, Day 56

Clinical Scoring of Facial Ageing Signs

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)

Time frame: Baseline, Day 28, and Day 56

Secondary Outcomes

Trans-epidermal water loss(TEWL)

trans-epidermal water loss using Vapometer (Vapometer, Delfin)

Time frame: Baseline, Day 28, Day 56

Skin Hydration Index

Hydration Index using Corneometer(Corneometer CM 825, Courage-Khazaka)

Time frame: Baseline, Day 28, Day 56

Epidermal Proteomic Profile Changes

Characterization and untargeted proteomics analysis of epidermal biomarkers obtained via non-invasive tape-stripping (D-Squame) sampling

Time frame: Baseline and Day 56

Data from ClinicalTrials.gov

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