跳至主要内容
临床试验/CTRI/2025/10/096695
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

UAS Pharmaceuticals Pty Ltd1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年11月8日

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

申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr Robin Chugh

CCFT Laboratories

研究点 (1)

Loading locations...

相似试验