Inducing Redness Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in erythema index by Mexameter® MX 18 (
研究概览
简要总结
This clinical study employs a single-center, split-face, randomized, and on-site controlled design to compare two methods for inducing skin redness (50% Glycolic Acid application and tape stripping) on the face and forearm in a minimum of 40 healthy female subjects. The study involves instrumental measurements (erythema index and a* value), photographic analysis, and expert clinical grading at multiple time points (baseline, 10min, 30min, 1h, 2h, and 4h after induction) to evaluate and compare the efficacy and response profiles of both irritation models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Chinese female whose age range from 18 to 60 years old;
- •Be in general good health and good mental state;
- •Have no any broken, scars, birthmarks and other imperfections on the test area;
- •Redness/erythema ≥ grade 2 after modelling inducing (to ensure the consistency of the baseline for comparison);
- •Haven't applied Alpha hydroxyl acid in the past 3 months;
- •Not currently be participating in any other study involving the test area (Face and Forearm);
- •Not have participated in any other study involving the test area in the past one month;
- •Be willing to read, understand and able to sign the Informed Consent Form and Photo Release From;
- •Be willing to comply with all study protocol requirements.
排除标准
- •Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;
- •Having used antihistamine drugs in the past 1 week or immunosuppressants in the past 1 month;
- •Take anti-allergic drug/injections in the past 1 month;
- •Presently have allergies, allergic dermatitis or skin disease;
- •Have sensitivity or even allergy to topical products, ingredients or fragranced products;
- •Have history of allergies;
- •Have history of suffering from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
- •Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;
- •Has a chronic medical condition that may interfere with testing (e.g., asthma, insulin-dependent diabetes, lupus, rheumatoid arthritis or other immune/auto-immune diseases);
- •Have used any scrubs or peeling product (regardless of method) or self-tanning products or oil control products in the past 3 days;
- •Have received cosmetic medical procedures on the face (such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures or home use medical devices, etc.) in the past 1 month;
- •Have excessive sun exposure or ultraviolet light in the past 1 month;
- •Have applied ortho-hydroxybenzoic acid, hydroquinone in the past 3 months; or used prescriptions (such as antibiotic, retinoids, alpha hydroxyl acid and steroid), oral contraceptives (such as Diane 35®，Jasmine®， Holgyeme®，Syndi 35®，Regulon®);
- •Avoid providing emergency contact;
- •Subjects that are not compliant to the selection criteria or not proper for participation as determined by Principal Investigator;
- •An employee of the cosmetic companies or Shanghai China-Norm Quality technical service Co., Ltd.
结局指标
主要结局
Change in erythema index by Mexameter® MX 18 (
时间窗: From baseline to 4-hour after inducing
Change in a* value by Chromameter CM26dG
时间窗: From baseline to 4-hour after inducing
The a\*value is a parameter in the CIELAB color space (also known as Lab) that quantifies a color's position along the red-green axis .
Facial Erythema Severity via VISIA-CRP Imaging
时间窗: From baseline to 4-hour after inducing
Forearm Erythema Intensity via Cross-Polarized Light Imaging
时间窗: From baseline to 4-hour inducing
Change in erythema index by Mexameter® MX 18 (
时间窗: From baseline to 4-hour after inducing
Change in a* value by Chromameter CM26dG
时间窗: From baseline to 4-hour after inducing
The a\*value is a parameter in the CIELAB color space (also known as Lab) that quantifies a color's position along the red-green axis .
Facial Erythema Severity via VISIA-CRP Imaging
时间窗: From baseline to 4-hour after inducing
Forearm Erythema Intensity via Cross-Polarized Light Imaging
时间窗: From baseline to 4-hour inducing
次要结局
未报告次要终点