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临床试验/CTRI/2025/09/094699
CTRI/2025/09/094699尚未招募Unknown

A Clinical study to Evaluate the Efficacy and Tolerance of Reginald Men Zeus Lip Serum/Balm on Human Lips

Btm Ventures Private Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年9月23日最近更新:
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试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
1. Change in hydration
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A clinical study to check the efficacy and tolerance ability

Test Product: Reginald Men Zeus Lip Serum/Balm Dose: Gently use the Reginald men Zeus Lip Serum/Balm twice a day for 4 weeks. Route of Administration: Topical Duration: 28days Assessments: 1. Change in hydration

  1. Change in Melanin 

  2. DSLR imaging 4. Visual Grading 5. Dermascope imaging Male and Female with age 18-45 (80:20)

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)Presence of visible lip dryness, dullness or pigmentation.
  • •Subjects willing to give written informed consent 4)Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
  • •Signed informed consent form.

排除标准

  • •Pregnant or nursing mothers
  • •Current dermatological treatments on the lips.
  • •Active cold sores, infections, open wounds, or trauma to the lips.
  • •4.Tolerance rating included in the past-treatment questionnaire.
  • •5.volunteers to report and discomfort or adverse events during the study period 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 7.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).

结局指标

主要结局

1. Change in hydration

时间窗: At t0, t30min, t28days

2. Change in Melanin

时间窗: At t0, t30min, t28days

3. DSLR imaging

时间窗: At t0, t30min, t28days

4. Visual Grading

时间窗: At t0, t30min, t28days

5. Dermascope imaging

时间窗: At t0, t30min, t28days

次要结局

  • SGA(t28days)

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)

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