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

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.

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.