A Single-Centre, Randomized Placebo-Controlled Study to Assess the Skin Tone Enhancement Benefits of the Pearl Tomato® in Healthy Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1) Overall hyperpigmentation, skin tone, tactile smoothness, brightness, and radiance.
研究概览
简要总结
The skin is the largest organ of the human body, and its appearance can be influenced by various internal and external factors. Skin tone enhancement, often referred to as skin brightening or lightening, has become a significant focus in dermatological research and the cosmetic industry. The pursuit of even skin tone and reduction of hyperpigmentation is driven by both aesthetic desires and clinical needs. Recently, there has been a growing interest in natural and safer alternatives for skin tone enhancement. Pre-clinical studies have elucidated the promising potential of Pearl Tomato extract in skincare formulations. Research conducted by Vesta Nutra has demonstrated the efficacy of Pearl Tomato as a melanin inhibitor and depigmentation agent. Pearl Tomato exhibited high melanin inhibition activity against UV- and Forskolin-induced melanin synthesis, as well as mushroom tyrosinase, an enzyme crucial for melanin production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Indian male and female participants aged 18-50 years.
- •Fitzpatrick Skin Types I-IV.
- •Presence of visible facial dark spots and pigmentation.
- •Healthy face skin free of eczema, wounds, and inflammatory scars.
- •Willing to comply with study requirements.
排除标准
- •Participants with chronic dermatosis or cutaneous hypersensitivity.
- •Clinically significant systemic or cutaneous disease, chronic illness, or recent major surgery.
- •Allergy or sensitivity to specified products or substances.
- •Pregnant or breastfeeding women, or use of hormonal birth control.
- •Recent participation in another clinical trial.
- •Current medication influencing study interpretation.
- •Unwillingness to discontinue other facial products.
结局指标
主要结局
1) Overall hyperpigmentation, skin tone, tactile smoothness, brightness, and radiance.
时间窗: Day 0, Day 15, Day 30, Day 60 & Day 90
2) Improvement in skin brightness and investigator’s assessment on skin brightness, tone, smoothness, glow ,radiance, colour.
时间窗: Day 0, Day 15, Day 30, Day 60 & Day 90
3) Measurement of skin tone , UV pigmentation, dark spots, pores and wrinkles.
时间窗: Day 0, Day 15, Day 30, Day 60 & Day 90
4) Skin colour assessment using Colori Probe.
时间窗: Day 0, Day 15, Day 30, Day 60 & Day 90
5) TEWL, Elasticity, and Hydration assessments using DermaLab Probes.
时间窗: Day 0, Day 15, Day 30, Day 60 & Day 90
6) Change in tyrosinase biomarker level.
时间窗: Day 0, Day 15, Day 30, Day 60 & Day 90
次要结局
- 1. Record any change in vital signs (blood pressure, pulse rate, body temperature).(2. Record any change in CBS parameters, Liver Function Test (LFT), Renal Function Test (RFT) parameters and RBS.)
研究者
Dr Sohandas Shetty
TrialGuna Private Limited