跳至主要内容
临床试验/CTRI/2025/09/094362
CTRI/2025/09/094362尚未招募Unknown

A Clinical study to Evaluate the effectiveness of Reginald men Apollo Facewash for skin brightening and hydration

Btm Ventures Private Limited1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年9月18日

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
4. Change in TEWL

研究概览

简要总结

A single blind one arm study.

Each participant entering the trial will be assigned to a regimen of investigational product with the below assessments.

-       Skin Gloss by Glossymeter (T0, T30min, T14Days, T28days)

-       Skin Colour by Chromameter (T0, T14Days, T28days)

-       Skin Pigmentation by Mexameter (T0 , T14days, T28 days)

-       Skin Hydration with Corneometer (T0, T30min,T14days,T28days)

-       TEWL for moisture barrier (T0, T30min,T14days,T28days)

-       Dermat evaluation on a 5 point ordinal scale would be used for the blemishes (T0,T14and T28)

-       Dermat evaluation on a 5 point ordinal scale would be used for the pore cleanliness post dermascope (T0, T14, T28)

-       HD Imaging with DSLR or Visioscan (T0 and T28)

-       Dermascopy Images ( T0 and T28day)

-       Subject’s Self Assessments. (T28 only)

Male and Female with age 18-45 (80:20), Volunteers-36

Assessment Time: T0min, T+30 mins, T+14days, T+28 days

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)

入选标准

  • Gender: Male and Female with age 18-45 (80:20) 2) Subjects with mild blemishes and dull skin.
  • Subjects willing to give written informed consent 4) 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.

排除标准

  • 1.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
  • 2.Have open sores or open lesions in the treatment area(s).
  • 3.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
  • 4.Have participated in any interventional clinical trial in the previous 90 days.
  • 5.Have a known sensitivity to any of the constituents of the test product including sensitivities.
  • Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
  • Have not skin related issues.

结局指标

主要结局

4. Change in TEWL

时间窗: At T0mins , T30mins, Day14 and T28days

5. Change in Skin discoloration

时间窗: At T0mins , T30mins, Day14 and T28days

6. Change in Skin Pigmentation

时间窗: At T0mins , T30mins, Day14 and T28days

3. Change in Skin hydration

时间窗: At T0mins , T30mins, Day14 and T28days

1. Change in skin brightness

时间窗: At T0mins , T30mins, Day14 and T28days

2. Change in Skin Softness

时间窗: At T0mins , T30mins, Day14 and T28days

次要结局

  • SGA(At 28days)

研究者

发起方
Btm Ventures Private Limited
申办方类型
Pharmaceutical industry-Indian
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