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
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.
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