The Effectiveness of a Whitening and Anti-Aging Bilayering Serum and Cream Containing Gamma-Aminobutyric Acid (GABA) 3%, Dimethylaminoethanol (DMAE) 2%, Cysteamine 2.5%, and Bakuchiol 1%
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Skin Luminance (L*) as measured by Chromameter.
研究概览
简要总结
This study aims to evaluate the clinical efficacy and safety of a multi-functional bilayering skincare regimen-consisting of a serum and cream-for improving skin brightness and reducing wrinkles. The formulation combines four active ingredients: Gamma-Aminobutyric Acid (GABA) 3%, Dimethylaminoethanol (DMAE) 2%, Cysteamine 2.5%, and Bakuchiol 1%. In an 8-week, double-blind, randomized, placebo-controlled trial involving 44 female subjects with Fitzpatrick skin types III-V, investigators will assess changes in skin brightness (L-value), wrinkle scores, pore counts, and melanin/erythema indices using standardized imaging and measurement tools. The primary goal is to determine if this specific combination therapy significantly enhances skin whitening and anti-aging outcomes compared to a placebo.
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, Investigator, Outcomes Assessor)
盲法说明
The active products and placebo were provided in identical packaging, labeled with unique codes. Neither the participants nor the investigators knew which group received the active bilayering formulation until the completion of the 8-week study and data analysis
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females aged 30-50 years.
排除标准
- •History of hypersensitivity to GABA, DMAE, Cysteamine, or Bakuchiol.
- •Recent facial aesthetic procedures (e.g., laser, chemical peel) within the last 3 months.
研究组 & 干预措施
Bilayering Treatment Group
Participants apply a serum of GABA 3% and DMAE 2% followed by a cream containing Cysteamine 2.5% and Bakuchiol 1% to the face twice daily for 8 weeks. to the face twice daily for 8 weeks.
干预措施: GABA (Drug)
Bilayering Treatment Group
Participants apply a serum of GABA 3% and DMAE 2% followed by a cream containing Cysteamine 2.5% and Bakuchiol 1% to the face twice daily for 8 weeks. to the face twice daily for 8 weeks.
干预措施: DMAE (Drug)
Bilayering Treatment Group
Participants apply a serum of GABA 3% and DMAE 2% followed by a cream containing Cysteamine 2.5% and Bakuchiol 1% to the face twice daily for 8 weeks. to the face twice daily for 8 weeks.
干预措施: Cysteamine (Drug)
Bilayering Treatment Group
Participants apply a serum of GABA 3% and DMAE 2% followed by a cream containing Cysteamine 2.5% and Bakuchiol 1% to the face twice daily for 8 weeks. to the face twice daily for 8 weeks.
干预措施: Bakuchiol (Drug)
Placebo Control Group
Participants apply a placebo serum and cream, identical in appearance, fragrance, and texture to the active products but without the active ingredients (GABA, DMAE, Cysteamine, and Bakuchiol), twice daily for 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change in Skin Luminance (L*) as measured by Chromameter.
时间窗: Baseline (Day 0) and Week 8 (Day 56).
Skin color is assessed using the CIE Lab\* system. The L\* parameter specifically measures luminance/brightness on a scale of 0 (black) to 100 (white). An increase in L\* value indicates an improvement in skin lightness
Percentage change in skin wrinkles as assessed by Skin Analyzer.
时间窗: (Day 0) and Week 8 (Day 56).
The Skin Analyzer evaluates the depth and area of facial wrinkles through digital imaging, providing a percentage value of the analyzed area. A lower percentage indicates a reduction in wrinkle appearance.
次要结局
未报告次要终点
研究者
Widya Widita
MD, Dermatologist
Hasanuddin University