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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Chinese women aged 35 to 60 years in good general health.
- •Self-reported dry skin type.
- •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.
- •Willingness to avoid excessive sun exposure and comply with all study procedures including tape stripping and biosampling.
- •Bilateral forearms clear of scars, wounds, or significant pigment spots.
排除标准
- •Current pregnancy, breastfeeding, or planning to become pregnant.
- •Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products).
- •History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.).
- •Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis).
- •Allergies to cosmetics, personal care products, or their ingredients.
- •Excessive UV exposure or frequent sauna/water sports usage.
- •Use of antihistamines, antibiotics, corticosteroids, or NSAIDs within the relevant washout periods.
- •Participation in any other clinical trial within the past 30 days.
研究组 & 干预措施
Active Formulation A
Zones applying 0.24% active formulation
干预措施: Cosmetic Topical Product A (Other)
Active Formulation B
Zones applying 0.05% active formulation
干预措施: Cosmetic Topical Product B (Other)
Vehicle Control
Zones applying the formulation base without active extract
干预措施: Vehicle (Other)
Untreated Zone
Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics
结局指标
主要结局
Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)
时间窗: 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
时间窗: 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
次要结局
未报告次要终点