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

NCT07780799 | Active Not Recruiting

• 1 other identifier: ACR_EV_25-11289_01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Dry Skin

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Baseline, Day 28, and Day 56

Secondary Outcomes (3)

• Trans-epidermal water loss(TEWL)

  Baseline, Day 28, Day 56

• Skin Hydration Index

  Baseline, Day 28, Day 56

• Epidermal Proteomic Profile Changes

  Baseline and Day 56

Study Arms (4)

Experimental: 0.05% Active Formulation

EXPERIMENTAL

Formulation with 0.05% botanic extract

Other: Cosmetic Topical Formulation 1

Placebo: Vehicle control 1

PLACEBO COMPARATOR

Applying the placebo formula without active ingredient

Other: Cosmetic Base of Topical Formulation 1

Experimental: 0.14% Active Formulation

EXPERIMENTAL

Formulation with 0.14% botanic extract

Other: Cosmetic Topical Formulation 2

Placebo: Vehicle Control 2

PLACEBO COMPARATOR

Applying the placebo formula without active ingredient

Other: Cosmetic Base of Topical Formulation 2

Interventions

Cosmetic Topical Formulation 1 OTHER

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

Experimental: 0.05% Active Formulation

Cosmetic Base of Topical Formulation 1 OTHER

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

Placebo: Vehicle control 1

Cosmetic Topical Formulation 2 OTHER

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

Experimental: 0.14% Active Formulation

Cosmetic Base of Topical Formulation 2 OTHER

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

Placebo: Vehicle Control 2

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

L'OREAL R&I China

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 24, 2026
• Study Start: October 11, 2025
• Primary Completion: December 29, 2025
• Study Completion (Estimated): September 25, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)