Evaluation of the Scalp Skin Care Effects of Premium Scalp Revitalizing Essence、Premium Scalp Revitalizing Essence 2、Premium Scalp Revitalizing Essence 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sebum Content
研究概览
简要总结
The study aims to evaluate the efficacy of the Premium Scalp Revitalizing Essence on human scalp skin. A total of 60 healthy adults, aged 18 to 60, will be recruited and randomly assigned into five groups receiving different formulations. Participants will use the product once daily for 56 days, and their scalp conditions will be assessed through skin texture tests at multiple time points. Key parameters such as sebum content, overall hair loss, hair density, scalp condition, and hair length will be measured.
详细描述
This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.
Sixty healthy adults aged from 18 to 60 will be recruited and randomly assigned into five groups, with 12 individuals in each group. Group 1 uses Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with caffeine and panthenol); Group 3 uses Base + IGF-1 & FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles; Group 5 uses Base + Centella Asiatica Exosome + IGF-1 & FGF-7. Before using the test product, all 60 participants undergo the first scalp skin texture test. After 14 days of using the test product, a second scalp skin texture test is conducted; after 28 days of use, a third test is performed; after 42 days of use, a fourth test is conducted; and after 56 days of use, a fifth test is carried out. The scalp skin texture tests include measurements of skin (1) sebum content, (2) overall hair loss, (3) hair density, (4) scalp condition, (5) hair length, and other parameters. The Sebumeter® SM815 probe of the MPA580 device and the ScalpX Intelligent Scalp Diagnostic System will be used to measure the parameters of the study.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults of any gender from the age of 18 to 60 years (inclusive).
- •Absence of chronic diseases, major illnesses, or allergies.
- •Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coro-nary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant
排除标准
- •Currently taking any medication or using any scalp care products
结局指标
主要结局
Sebum Content
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Assess oil levels on the scalp at standardized scalp sites (left, right, and vertex). Measured with C+K Multi Probe Adaptor MPA580 system using the Sebumeter® SM815 probe based on the grease spot photometry method with the sebum measurement cassette tape. The change in light transmission corresponds to the amount of sebum on the tape and is displayed on a scale from 0 to 350 units.
Sebum Content
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Assess oil levels on the scalp at standardized scalp sites (left, right, and vertex). Measured with C+K Multi Probe Adaptor MPA580 system using the Sebumeter® SM815 probe based on the grease spot photometry method with the sebum measurement cassette tape. The change in light transmission corresponds to the amount of sebum on the tape and is displayed on a scale from 0 to 350 units.
Hair length
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair length (cm): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Hair density
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair density (number of hairs/cm-square): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Hair thickness
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Hair loss
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair loss: Assessed by the standardized hair combing test by counting the number of hairs shed after the participants' hair was combed over a clean surface for 60 strokes.
次要结局
未报告次要终点
研究者
Tsong-Min Chang
Vice President
Hungkuang University