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

A Single-Center, Double-Blinded, Randomized, Placebo-Controlled, Prospective Study to Evaluate the Efficacy and Safety of a Botanical Extract in Skincare Formulations for Skin Barrier Repair on Healthy Volunteers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Impaired Barrier
• Intervention / Treatment: Other: Cosmetic Topical Product A; Other: Cosmetic Topical Product B; Other: Vehicle

Detailed Description

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
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • L'OREAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Formulation A; Zones applying 0.24% active formulation	Other: Cosmetic Topical Product A; Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days.
Experimental: Active Formulation B; Zones applying 0.05% active formulation	Other: Cosmetic Topical Product B; Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days.
Placebo Comparator: Vehicle Control; Zones applying the formulation base without active extract	Other: Vehicle; Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days.
No Intervention: Untreated Zone; Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)	Dermatological grading of erythema, dryness, roughness, edema, desquamation and post-inflammatory hyperpigmentation using standard clinical scales	Baseline, Tafter, T3h, Day 1, Day 3, Day 7, and Day 14
Hydration	Hydration index measured using Corneometer	Baseline, Tafter, Timm, T1h, T3h, Day 1, Day 3, Day 7, and Day 14
TEWL	Trans-epidermal water loss using Vapometer	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Structural Changes	Non-invasive evaluation of epidermis and dermis thickness/density using high-frequency ultrasound	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.	Baseline, Day 7

Collaborators and Investigators

• Sponsor: L'Oreal

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Actual): November 3, 2025
• Study Completion (Estimated): July 25, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ACR_EV_25-11289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No