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

NCT07780799 · tracked via the Priya Life Science China tracker

Sponsor

L'Oreal

Phase

Not applicable

Started

2025-10-11

Last updated

2026-08-24

Condition(s) studied

AgingDry Skin

Investigational drug(s) / intervention(s)

Cosmetic Topical Formulation 1Cosmetic Base of Topical Formulation 1Cosmetic Topical Formulation 2Cosmetic Base of Topical Formulation 2

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

Cosmetic Base of Topical Formulation 1: 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 2: Topical skincare formulation containing Botanical Extract (Concentration 2, 0.14%). Applied topically twice daily for 56 days.

Cosmetic Base of Topical Formulation 2: Topical skincare formulation base (identical to Active Formulation 2 but without the active botanical extract). Applied topically twice daily for 56 days.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

35 Years

Max age

60 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Instrumental Evaluation of Skin Tone, Elasticity, and Wrinkles — Baseline, Day 28, Day 56
Evaluation of skin color/tone using Colorimeter (CL400), skin elasticity using Cutometer (MPA 580), and crow's feet wrinkles using PRIMOS CR (Canfield Scientific)
Clinical Scoring of Facial Ageing Signs — Baseline, Day 28, and Day 56
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)

Trial sites (1)

Facility	City	Region	Status
L'OREAL R&I China	Shanghai	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07780799 on ClinicalTrials.gov ↗ ← All trials in China