The Effectiveness of Epidermal Growth Factor Serum for the Improvement of Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles at the Institute of Dermatology: a Single-centered Pilot Study With a One-group Before-and-after Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Facial Skin Hydration
研究概览
简要总结
EGF is a polypeptide that promotes cell differentiation and collagen production while decreasing melanin production. This study is designed to study its effectiveness in improving the texture and appearance of facial skin after daily topical application. We hypothesized that EGF would improve facial skin hydration, elasticity, pigmentation, and wrinkles.
详细描述
All patients gave written informed consent for epidermal growth factor serum application on the face. The pilot study enrolls thirty patients compared to pre and post-serum used to evaluate facial skin hydration, transepidermal water loss, elasticity, pigmentation, and wrinkles measured by corneometer, tewameter, cutometer, visioscan, and mexameter respectively on day 0, then 8, 12, and 16 weeks. The study evaluates subject satisfaction and side effects after serum application as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Mild to moderate facial skin condition, as measured by 1-2 points on the hyperpigmentation status scale or 2-3 points on the wrinkle severity grading scale.
排除标准
- •Use of lotions or skin care products containing ingredients such as vitamin A/C, hydroquinone, or anti-aging agents.
- •Sunbathing
- •Hypersensitivity to serum components
- •Pregnancy and breast-feeding
- •Active skin diseases such as eczema or atopic dermatitis at the application site
研究组 & 干预措施
Epidermal Growth Factor Serum Application
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
干预措施: Epidermal Growth Factor (Drug)
结局指标
主要结局
Facial Skin Hydration
时间窗: 4 months (Baseline, Week 8, Week 12, Week 16)
Facial skin hydration was measured using a Corneometer, which provides readings in arbitrary units (a.u.). Measurements were taken at baseline (Day 0), Week 8, Week 12, and Week 16 under standardized environmental and procedural conditions to ensure reliability and accuracy. Higher values indicate better skin hydration, while lower values indicate increased dryness.
Transepidermal Water Loss
时间窗: 4 months
measured by tewameter on day 0, then at 8, 12, and 16 weeks.
Facial Skin Elasticity (R2 Parameter Via Cutometer)
时间窗: Baseline, Week 8, Week 12, Week 16
Skin elasticity was assessed using a Cutometer with the R2 parameter (Ua/Uf), which measures gross elasticity. R2 values range from 0 to 1.0, with higher values indicating better skin elasticity. Measurements were collected under standardized conditions at Baseline (Day 0), Week 8, Week 12, and Week 16.
Facial Skin Wrinkles
时间窗: 4 months
Visioscan measurements were taken at baseline, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale.
Facial Melanin Index
时间窗: 4 months
Facial pigmentation was assessed using the Mexameter, which measures melanin content via light absorption and reflection. The device reports values on a scale from 0 to 999, where higher values represent greater melanin concentration. Measurements were collected at standardized facial sites at Baseline, Week 8, Week 12, and Week 16. Higher scores indicate worse pigmentation.
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
时间窗: 4 months
Facial skin appearance was evaluated using the Subject Global Aesthetic Improvement Scale (SGAIS), a 5-point scale where higher scores indicate greater improvement. Scores were assigned by two board-certified dermatologists who assessed photographs taken by the Visia-CR imaging system at Baseline, Week 8, Week 12, and Week 16. SGAIS scoring definition: 1 = Worse, 2 = Mild improvement (\<25%), 3 = Moderate (25-49%), 4 = Much improved (50-74%), 5 = Very much improved (≥75%).
次要结局
- Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation(4 months)
- Adverse Events(4 months)
研究者
Supawee Phanmamuang, MD
Resident of Dermatology
Institute of Dermatology, Thailand