Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Barrier Repair

NCT07645339 · tracked via the Priya Life Science China tracker

Sponsor

L'Oreal

Phase

Not applicable

Started

2025-10-13

Last updated

2026-11-09

Condition(s) studied

Impaired Barrier

Investigational drug(s) / intervention(s)

Cosmetic Topical Product ACosmetic Topical Product BVehicle

Cosmetic Topical Product A: Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days.

Cosmetic Topical Product B: Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days.

Vehicle: Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days.

Study summary

This is a single-center, double-blinded, placebo-controlled, prospective clinical study designed to evaluate the skin barrier repair efficacy and local tolerance of topical cosmetic formulations containing a botanical extract. Skin barrier challenge is induced via standardized tape stripping on the volar forearm of healthy subjects. The study will evaluate and compare the repair kinetics of two concentrations of the active formulation, a vehicle, and an untreated control zone over a 14-day application period.

Eligibility

Sex

FEMALE

Min age

35 Years

Max age

60 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. Chinese women aged 35 to 60 years in good general health. 2. Self-reported dry skin type. 3. a hydration index \< 35 and a trans-epidermal water loss (TEWL) ≥ 6g.m-2.h-1 on both anterior sides of the forearms at screening. 4. Willingness to avoid excessive sun exposure and comply with all study procedures including tape stripping and biosampling. 5. Bilateral forearms clear of scars, wounds, or significant pigment spots. 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. 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 the relevant washout periods. 8. Participation in any other clinical trial within the past 30 days.

Primary outcome measure(s)

Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH) — Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
Dermatological grading of erythema, dryness, roughness, edema, desquamation and post-inflammatory hyperpigmentation using standard clinical scales
Hydration — Baseline, Tafter (right after tape stripping), Timm (immediately after 1st product application), T1h(1 hour after 1st product application), T3h(3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
Hydration index measured using Corneometer
TEWL — Baseline, post-stripping (Tafter), immediately post-first application (Timm), 1 hour post-first application (T1h), 3 hours post-first application (T3h), Day 1, Day 3, Day 7, and Day 14.
Trans-epidermal water loss using Vapometer

Trial sites (1)

Facility	City	Region	Status
L'OREAL	Shanghai	China

More L'Oreal trials in China

Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Aging Active, not recruiting

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 NCT07645339 on ClinicalTrials.gov ↗ ← All trials in China