Exploring the Physiological Effects of Topical Kumkumadi Taila on Cutaneous Microcirculation and Melanogenesis in Hyperpigmentation: A Dermatoscopic Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in cutaneous microcirculation parameters (vessel density, morphology) within and around hyperpigmented lesions assessed via dermatoscopy at baseline, 8 weeks, and 12 weeks.
研究概览
简要总结
This single-center, prospective, post-marketing surveillance study aims to investigate the physiological effects of topically applied Kumkumadi Taila, a classical Ayurvedic medicine with a long history of use for hyperpigmentation.
The study will enroll 200 participants with clinically diagnosed hyperpigmentation (melasma, post-inflammatory hyperpigmentation, or solar lentigines).
Participants will apply Kumkumadi Taila topically for 8 weeks, with follow-up assessments at 8 and 12 weeks.
- The primary outcomes are changes in cutaneous microcirculation (vessel density and morphology) and melanin distribution patterns, as assessed through non-invasive dermatoscopy.
- Secondary outcomes include subjective improvements in hyperpigmentation, as measured by the Melasma Area and Severity Index (MASI).
The study has been approved by the Institutional Ethics Committee (IEC) of Parul Institute of Ayurved, Parul University, Vadodara, Gujarat.
This research will contribute novel insights into the physiological basis of Kumkumadi Taila’s traditional use in managing hyperpigmentation and potentially inform future applications.
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
- •Skin Type : Fitzpatrick skin types III-VI (to ensure relevance to individuals prone to hyperpigmentation).
- •Hyperpigmentation Diagnosis: Clinically diagnosed with one of the following types of hyperpigmentation: Melasma, Post-inflammatory hyperpigmentation, Solar lentigines (sun spots).
排除标准
- •Pregnancy or Lactation: Pregnant or breastfeeding women (due to potential hormonal influences on pigmentation).
- •Active Skin Infections: Presence of active skin infections or inflammatory conditions (e.g., eczema, psoriasis) at the study site (to avoid confounding the assessment of hyperpigmentation).
结局指标
主要结局
Changes in cutaneous microcirculation parameters (vessel density, morphology) within and around hyperpigmented lesions assessed via dermatoscopy at baseline, 8 weeks, and 12 weeks.
时间窗: Baseline, 8 weeks, and 12 weeks.
Alterations in melanin distribution patterns within hyperpigmented lesions as observed through dermatoscopy at baseline, 8 weeks, and 12 weeks.
时间窗: Baseline, 8 weeks, and 12 weeks.
次要结局
- Subjective assessment of hyperpigmentation improvement using the Melasma Area and Severity Index (MASI) questionnaire at baseline, 8 weeks, and 12 weeks(Baseline, 8 weeks, and 12 weeks.)
研究者
Dr Smita Chatrabhuji
Parul Institute of Ayurved