Efficacy Validation of Deep Microspicule Cream for Anti-aging and Whitening on Mature Skin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Skin Hydration,Transepidermal Water Loss (TEWL),Skin Elasticity,Erythema Index,Skin Color
研究概览
简要总结
This study is a single-center, prospective, split-face self-controlled pilot trial designed to evaluate the anti-aging and whitening efficacy of the "Deep Microspicule Cream" (containing patented crystal microspicules encapsulating Penghu seaweed extract) on mature skin.
详细描述
This study is a single-center, prospective, split-face self-controlled pilot trial.
10 healthy participants aged 40-65 who present signs of skin aging or hyperpigmentation will be enrolled.
Intervention Side (Active): Participants will apply a green-bean-sized amount of Deep Microspicule Cream on the assigned side, gently massaging to let the microspicules roll on the skin, followed by the application of Deep Essence to dissolve the microspicules.
Control Side: Participants will apply Deep Essence only. The applications are performed 3 times per week at bedtime. Clinical evaluations and instrument measurements are scheduled at Day 0 (baseline), Day 14, and Day 28. On assessment days, participants must cleanse their faces and rest in a controlled environment for 25-30 minutes without applying any cosmetics before undergoing non-invasive skin assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants aged 40-65 years.
- •Presence of at least one facial aging or hyperpigmentation feature (e.g., eye area sagging, eye bags, crow's feet, fine lines, freckles, sun spots, uneven skin tone, or dullness).
- •Willing to complete 3 study visits within 4 weeks, comply with instrumental measurements, and maintain product logs.
- •Willing to sign the Informed Consent Form (ICF).
排除标准
- •Received facial aesthetic treatments (e.g., lasers, chemical peels, microneedling, energy-based therapies) within 4 weeks.
- •Used topical/oral retinoic acid or strong whitening creams (e.g., high-concentration hydroquinone) within 4 weeks.
- •Severe sensitive skin, active atopic dermatitis, or obvious facial skin lesions/infections.
- •Facial salon or exfoliation treatments more frequent than once every 2 weeks.
- •Known allergy to seaweed-derived ingredients or product preservative systems.
- •Uncontrolled systemic diseases (e.g., diabetes, kidney/liver/cardiovascular diseases, severe infections, endocrine disorders, or cancer).
- •Pregnant, lactating, or planning to become pregnant.
- •Deemed unsuitable for participation by the investigator.
结局指标
主要结局
Skin Hydration,Transepidermal Water Loss (TEWL),Skin Elasticity,Erythema Index,Skin Color
时间窗: Baseline (Day 0), Day 14, Day 28
"Using the Cutometer® MPA 580 to sequentially measure skin hydration, transepidermal water loss (TEWL), skin elasticity, erythema index, and skin color."
次要结局
- skin texture smoothness, visual radiance (glossiness), and skin firmness(Baseline (Day 0), Day 14, Day 28)