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

N/AActive Not RecruitingNCT07645339

L'Oreal35 enrolled

Overview

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.

Healthy female subjects will undergo a standardized skin barrier challenge (tape-stripping) on designated zones of their volar forearms at baseline. Formulations containing different concentrations of a botanical extract (Active Formulation A and Active Formulation B), a vehicle control, and an untreated control will be assigned to the randomized zones. Products will be applied topically twice daily for 14 days. Skin barrier repair efficacy will be assessed using clinical gradings and instrumental measurements, including Trans-Epidermal Water Loss (TEWL) and skin hydration. Local tolerance will be evaluated via clinical grading. Non-invasive skin surface biomaterial collection may be performed at designated time points for skin proteomics and lipidomics analysis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Impaired Barrier

Interventions

Cosmetic Topical Product AOTHER

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

Cosmetic Topical Product BOTHER

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

VehicleOTHER

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

Eligibility

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

Medical Language ↔ Plain English

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.

Locations (1)

L'OREAL

Shanghai, China

Outcomes

Primary Outcomes

Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)

Dermatological grading of erythema, dryness, roughness, edema, desquamation and post-inflammatory hyperpigmentation using standard clinical scales

Time frame: Baseline, Tafter, T3h, Day 1, Day 3, Day 7, and Day 14

Hydration

Hydration index measured using Corneometer

Time frame: Baseline, Tafter, Timm, T1h, T3h, Day 1, Day 3, Day 7, and Day 14

TEWL

Trans-epidermal water loss using Vapometer

Time frame: 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.

Secondary Outcomes

Skin Structural Changes

Non-invasive evaluation of epidermis and dermis thickness/density using high-frequency ultrasound

Time frame: Baseline, Day 3, Day 7, and Day 14

Epidermal Proteomic and Lipidomic Profile

Characterization of stratum corneum biomarkers obtained via non-invasive tape-stripping samplings.

Time frame: Baseline, Day 7

Data from ClinicalTrials.gov

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