A Clinical study to Evaluate the efficacy of TomaGlow Brightening Cream for skin Brightening
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Change in Skin Gloss
研究概览
简要总结
| An open label one arm study to check Saftey and tolerability for Skin brightness |
Assessment Points:
Skin Gloss by Glossymeter (T0, T30min, Day 14, and Day 28)
Skin Pigmentation by Mexameter Face(Melanin Index) (T0, Day 14, and Day 28)
Skin Hydration by Corneometer (T0, T30min, Day 14, and Day 28)
Dark Spots by Visioface (T0, Day 14, and Day 28)
Skin discoloration by Chromameter as L value in L*a*b space (T0, Day 14, and Day 28)
Skin Barrier by TEWAMETER (T0, Day 14, and Day 28)
Test Duration-28 Days, Volunteers-36
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
入选标准
- •1.Gender Male and Female 30 Female and 6 males.
- •2.Subject having dull or dehydrated skin with pigmentation 3.Non-pregnant, non-lactating female.
- •4.Age between 18 to
- •5.Subject willing to give written informed consent 6.Women of child bearing potential must have a negative urine pregnancy test 7.Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
- •8.Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •1.Subjects who are pregnant, breast feeding, or planning to become pregnant during the study 2.Volunteers with skin conditions such as eczema, psoriasis, etc 3.Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
- •4.Have open sore or open lesions in the treatment area.
- •5.Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •6.Have participated in any interventional clinical trial in the previous 30 days.
- •7.Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
- •8.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
- •9.Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
结局指标
主要结局
1. Change in Skin Gloss
时间窗: At Day 0, Day 14, 28 Day
2. Change in Hydration
时间窗: At Day 0, Day 14, 28 Day
3. Change in Skin Lightness
时间窗: At Day 0, Day 14, 28 Day
4. Change in Melanin Index
时间窗: At Day 0, Day 14, 28 Day
5. Change in Smoothness and Skin Even Tone
时间窗: At Day 0, Day 14, 28 Day
6. Change in Dark Spots
时间窗: At Day 0, Day 14, 28 Day
7. Change in TEWL
时间窗: At Day 0, Day 14, 28 Day
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories