CTRI/2025/07/090872尚未招募Phase 3 4
Evaluation of an Under-Eye Cream: Open-label Single Arm Interventional Prospective Study
Silphion Research Private Limited1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月30日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in the pigmentary, vascular or mixed type of peri orbital hyperpigmentation
研究概览
简要总结
This open-label, single-arm, 16-week clinical trial evaluates an under-eye cream containing retinol and pycnogenol in 30 participants aged 18–60 with visible under-eye pigmentation. The cream is applied nightly, alongside daily SPF 40 sunscreen. Assessments include clinical photos, Reveal® imaging, and Dermalab biophysical measurements every 4 weeks. Participants will avoid other under-eye treatments, and adverse events will be monitored and managed. Data will be securely stored with participant confidentiality maintained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •18–60 years 2)Visible under-eye pigmentation 3)Consent to participate 4)Comply with follow-up schedule.
排除标准
- •Recent use of topical depigmenting agents on the face(past 4 weeks) 2)Known allergy to any ingredient in the cream Ongoing dermatological or systemic illness affecting the face 3)Pregnant or lactating women.
结局指标
主要结局
Improvement in the pigmentary, vascular or mixed type of peri orbital hyperpigmentation
时间窗: Day 0, Week 4,8,12 & 16
次要结局
- To evaluate participant-reported outcomes, including self-assessed wrinkle improvement and satisfaction with the appearance of their under-eye area.
研究者
Dr.T. Vanathi
Render Skin and Hair
研究点 (1)
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