CTRI/2024/07/071534已完成Post Marketing Surveillance
A Clinical Study to Evaluate the Brightening Potential of The Derma Co 15 percent Vitamin C Intense Brightening Ampoule Kit on Healthy Human Subjects
Honasa Consumer Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年8月10日最近更新:
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Change in Lightness
研究概览
简要总结
Single-arm clinical study to evaluate the Brightening Potential of The Derma Co 15% Vitamin C Intense Brightening Ampoule Kit
1. The Derma Co 15% Vitamin C Intense Brightening Ampoule Kit
The products will be tested on 32 human volunteers.
Assessment would Notice the improvement in Skin brightening, Melanin content, and skin Lightness with follow-up visits on Day 0, and Day 7.
The study is done as per BIS standard 4011
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
入选标准
- •1.Gender: Male or Female with age 18-45, with male:female (80:20) ratio with normal , oily (avoid acne and too much oily skin) and combination skin.
- •3 to 4 candidates with Sensitive skin.
- •Subjects willing to give written informed consent
- •Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 4.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 5.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 6.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
1. Change in Lightness
时间窗: At 0, 30 min, 7days
2. Change in melanin
时间窗: At 0, 30 min, 7days
3. Gloss by glossymeter
时间窗: At 0, 30 min, 7days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
Loading locations...
相似试验
尚未招募
Unknown
Skin Brightening activity of Vitamin C Microneedle Serum ShotCTRI/2025/09/094700Honasa Consumer Limited –(Brand – The Derma Co.)36
尚未招募
4 期
Effect of Regular Sunscreen Use on Skin Lightening IndexCTRI/2026/01/101810SILPHION RESEARCH PRIVATE LIMITED30
已完成
不适用
Study to Check Safety and Effectiveness of Skin Care ProductsCTRI/2025/09/094884ITC LIMITED90
已完成
Unknown
Anti-pigmentation and brightening activity of Plum Vitamin C SerumCTRI/2025/02/080649Pureplay Skin Science Pvt Ltd32
已完成
不适用
Evaluation of Hydrating Cream Effect on Subjects With Dry Skin.NCT07393191Lacer S.A.35