Impaired Barrier
Conditions
Brief 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.
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.
Interventions
OTHERCosmetic Topical Product B
Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days.
OTHERVehicle
Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days.
OTHERCosmetic Topical Product A
Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days.
Sponsors
L'Oreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Structural Changes | Baseline, Day 3, Day 7, and Day 14 | Non-invasive evaluation of epidermis and dermis thickness/density using high-frequency ultrasound |
| Epidermal Proteomic and Lipidomic Profile | Baseline, Day 7 | Characterization of stratum corneum biomarkers obtained via non-invasive tape-stripping samplings. |
Countries
China
Outcome results
None listed