Clinical-Instrumental Evaluation of the Efficacy of Two Cosmetic Products in Comparison: Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
This study evaluates the repairing efficacy of a cosmetic cream containing Picea abies extract compared to a placebo (cream without extract) and a benchmark product. The trial involves 60 healthy subjects (aged 18-60) with atopy-prone and sensitive skin.
Over a 21-day period, the primary objective is to measure improvements in skin barrier function via transepidermal water loss (TEWL) and skin moisturization. A dermatologist will also assess soothing effects by evaluating skin dryness, redness, and itching sensations. Secondary objectives include measuring skin inflammation markers (TNFα, TSLP, and TARC) and subject-perceived efficacy through self-assessment questionnaires.
详细描述
This is a multi-site, randomized, placebo-controlled, and benchmark-controlled clinical trial designed to evaluate the repairing and soothing efficacy of a cosmetic cream containing Picea abies extract. The study is conducted on 60 healthy male and female subjects (66 enrolled to account for a 10% dropout rate) aged 18 to 60 years who exhibit atopy-prone and sensitive skin.
Subjects are randomized into three parallel groups (N=20 per group):
Test Product: Atopic cream with Picea abies extract.
Placebo: Atopic cream without Picea abies extract.
Benchmark: A commercially available reference cream.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 18 to 60 years.
- •Caucasian ethnicity.
- •Subjects with atopy-prone skin on cheekbones and forearms, characterized by sensitive/reactive skin, redness, or itching.
- •Transepidermal water loss (TEWL) thresholds at screening: Cheekbones ≥ 20 g/m^2/h and Forearms ≥10 g/m^2/h.
- •Stable pharmacological therapy for at least one month without planned changes.
- •Subjects aware of study procedures and having signed an informed consent form.
排除标准
- •Acute or chronic diseases liable to interfere with study data or subject safety.
- •Participation in other clinical trials or insufficient washout period (14 days).
- •Known hypersensitivity or allergy to any ingredients in the test products.
- •Use of pharmacological treatments considered incompatible with the study requirements.
- •Presence of skin diseases that could interfere with instrumental measurements.
- •Pregnant or breastfeeding women, or women of childbearing potential unwilling to use precautions to avoid pregnancy.