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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Formulation A | Experimental | Zones applying 0.24% active formulation |
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| Active Formulation B | Experimental | Zones applying 0.05% active formulation |
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| Vehicle Control | Placebo Comparator | Zones applying the formulation base without active extract |
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| Untreated Zone | No Intervention | Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic Topical Product A | Other | Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days. |
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| 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 (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14 |
| Hydration | Hydration index measured using Corneometer | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L'OREAL | Shanghai | China |
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| Cosmetic Topical Product B | Other | Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days. |
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| Vehicle | Other | Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days. |
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Characterization of stratum corneum biomarkers obtained via non-invasive tape-stripping samplings.
| Baseline, Day 7 |