A single-arm, open-label clinical study to evaluate the efficacy and safety of the Baypure Clearing Serum in improving skin pigmentation, dark spots, hydration, and overall skin Parameters
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1. change in Skin Pigmentation
研究概览
简要总结
This is an open-label, single-arm study.
Participants will apply the Clearing Serum twice daily for 28 days.
Assessments will be performed at baseline (Day 0), Day 14, and Day 28.
Instrumental Assessments: [Comparing data of D14 and baseline, same Day 28 and
baseline]
• Skin Pigmentation: Mexameter – Melanin Index (Day 0, 14, 28)
• Skin Color: Colorimeter (Day 0, 14, 28) [Also, could be marker for Tanning]
• Skin Hydration: Corneometer (Day 0, 14, 28)
• Skin Barrier Function: TEWAmeter (Day 0, 14, 28)
• Dark Spots: Visioface (Day 0, 14, 28)
• Visioscan Imaging: Day 0 and 28
• HD Photography: DSLR, Day 0 and 28
Dermatologist Evaluation (5-point ordinal scale):
• Even Skin Tone (Day 0, 14, 28)
• Acne Scars (Day 0, 14, 28)
• Smoothness (Day 0, 14, 28)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, 18–45 years old
- •Visible pigmentation or dark spots
- •Willing to provide written informed consent
- •Women of childbearing potential must have a negative urine pregnancy test
- •Able and willing to comply with study procedures.
排除标准
- •Pregnant or breastfeeding women
- •History of systemic or skin cancers within the last 5 years
- •Open sores or lesions in the treatment area
- •Participation in another interventional trial within the past 90 days
- •Use of immunosuppressive or immunomodulatory medications
- •Any dermatological or systemic condition that may interfere with study results.
结局指标
主要结局
1. change in Skin Pigmentation
时间窗: At t0, t30min, t14days, t28days
2. change in Skin Color
时间窗: At t0, t30min, t14days, t28days
3. change in Skin Hydration
时间窗: At t0, t30min, t14days, t28days
4. change in TEWL
时间窗: At t0, t30min, t14days, t28days
5. change in Dark Spots
时间窗: At t0, t30min, t14days, t28days
6. change in Visioscan Imaging
时间窗: At t0, t30min, t14days, t28days
次要结局
- SGA(At t28days)
研究者
Dr Robin Chugh
CCFT Laboratories