跳至主要内容
临床试验/CTRI/2025/06/089375
CTRI/2025/06/089375尚未招募不适用

A monocentric, single group, 4 week trial to evaluate the skin anti-ageing benefits of a serum in women and its in use tolerance.

Earthy Biome1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年6月30日

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
1. 3D Imaging for wrinkles, fine lines and texture.

研究概览

简要总结

Improvement in overall facial skin appearance is most rapidly achieved through enhanced

moisturization. Moisturization occurs by increasing the water content of the epidermis, thereby

improving skin texture and reducing the appearance of fine lines and superficial wrinkles. The

skin naturally achieves hydration through dermal glycosaminoglycans (GAGs) such as hyaluronic

acid

PlumpX serum majorly consist of a complex of hyaluronates and rice extract which claim to have

the benefits of skin hydration and prevention of Transepidermal water loss. In addition it also

contains Lactobacillus/Soybean Ferment Extract which adds on to the effect of the hyaluronates.

The objective of this study is to validate the claim of the ability of this facial serum to deliver

skin benefits by promoting skin plumpness and hydration while minimizing fine lines/wrinkles and

improving the overall facial appearance

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Voluntary women from 35 years to 65 years of age.
  • Volunteers with mild to moderate wrinkles in crow’s feet area.
  • Having apparently healthy skin on test area.
  • Willingness to discontinue the use of other cosmetic products on face during the course of the study.
  • Willing to avoid unusual sun exposure as far as possible for the entire study duration.
  • Accepting not to use products with the same end benefit during the entire study duration.
  • Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
  • Ready to provide consent, having been informed orally and in writing of all information concerning the study procedures and study objectives.

排除标准

  • Female who is pregnant by UPT or lactating.
  • Any cutaneous conditions on test site (scars, moles, papules etc).
  • Participants hypersensitive to any of the components of the test product.
  • Participants having any hard damage to skin (e.g., excessive sunburn or suntan).
  • Participants on any systemic medical treatment which may interfere with the performance of the study treatment (presently or in the past 1 month).
  • Participant in an exclusion period or participating in any clinical trial within 30 days prior to screening.

结局指标

主要结局

1. 3D Imaging for wrinkles, fine lines and texture.

时间窗: Day 0, Day 30

2. Skin elasticity and firmness using CutoMeter.

时间窗: Day 0, Day 30

4. Self-assessment for product efficacy.

时间窗: Day 0, Day 30

3. Skin radiance using Glossmeter.

时间窗: Day 0, Day 30

次要结局

  • 1. Clinical evaluation for in-use skin tolerance.(2. Self-assessment questionnaire for in use tolerance.)

研究者

发起方
Earthy Biome
申办方类型
Other [Cosmetic company]

研究点 (1)

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