CTRI/2025/10/096695尚未招募Unknown
A Clinical Study To Evaluate The Efficacy Of Neutriderm KS Cream For Scars, Acne Scars And Stretch Marks
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Change in Skin Elasticity
研究概览
简要总结
A Single Blind clinical study.
Each participant entering the trial will be assigned to a regimen of investigational product.
Gender: Male and Female aged between18-50, Volunteers-36
Baseline Measurements:
- Skin Elasticity (Cutometer): (0, 30, 60 days and 90 Days)
- TEWL (Tewameter): (0, 30, 60 days and 90 Days)
- Skin Hydration (Corneometer): (0, 30, 60 days and 90 Days)
- Skin Color (Colorimeter): (0, 30, 60 days and 90 Days)
- Visible Height and Number of Scars: (0, 30, 60 days and 90 Days)
- Dermatological Evaluations (0-4 Scale):
o Redness
o Even Skin Tone
o Smoothness
o Skin Texture
o Softness
- HD Imaging with DSLR: (0, 30, 60 days and 90 Days)
- SGA
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
- •Gender: Male and Female aged between18-
- •Non-pregnant, non-lactating female
- •Subject has Scar, Acne mark and Stretch marks.
- •Subject willing to give written informed consent
- •Women of child bearing potential must have a negative urine pregnancy test.
- •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.
- •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
- •Subjects who are pregnant, breast feeding, or planning to become pregnant during the study
- •Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
- •Have open sore or open lesions in the treatment area
- •Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 30 days.
- •Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
- •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 Elasticity
时间窗: At T0, 30days, 60 days and 90 Days
2. change in height
时间窗: At T0, 30days, 60 days and 90 Days
3. Change in Skin Color
时间窗: At T0, 30days, 60 days and 90 Days
4. Change in skin hydration
时间窗: At T0, 30days, 60 days and 90 Days
5. Change in TEWL
时间窗: At T0, 30days, 60 days and 90 Days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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