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临床试验/NCT06706050
NCT06706050已完成1 期

Clinical Evaluation of Lactobarriome 5% Cream's Efficacy on Dry Skin for Improving Skin Hydration and Transepidermal Water Loss, Relieving Pruritus, and Altering the Skin Microbiome

Ho-Yeon Song1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年5月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Improvement of skin hydration and transepidermal water loss, and relieving pruritus

研究概览

简要总结

The purpose of this clinical trial is to assess the skin hydration and transepidermal water loss improvement, pruritus relief, and microbiome alteration effects of a Lactobacillus sp. product (Lactobarriome 5% cream) compared to a placebo cream to prove the skin improvement effects of Lactobarriome 5%, which is a nature-friendly material derived from intravaginal microflora that can replace chemical components commonly used as ingredients for existing cosmetics.

The impact of Lactobarriome 5% cream, formulated with LP51 culture filtrate, on dry skin was assessed through a 4-week double-blind clinical trial. Participants were selected based on predefined inclusion and exclusion criteria. Using a simple randomization method, participants were assigned to either the experimental group (receiving the test formulation) or the control group (receiving a placebo). The products were applied twice daily-morning and evening-to a 3 cm area on both the proximal and distal sides of the designated arm's crook. Clinical evaluations were conducted at baseline, as well as after 2 weeks and 4 weeks of product use. These assessments included visual inspections, subjective pruritus evaluations, skin hydration levels, and transepidermal water loss (TEWL) measurements, all performed by a skincare professional. Furthermore, magnified images were captured using a Folliscope, and skin samples were collected to analyze microbial changes post-treatment. Before application, the designated arm was washed with water and allowed to rest for 30 minutes under controlled conditions (22±2°C, 50±10% relative humidity).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 61 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy participants, including men and women, aged 19-70
  • Without acute or chronic diseases (excluding atopic dermatitis)
  • Individuals suffering from dry skin and itchiness in the test area (crook of the arm)
  • Those with objectively proven skin barrier damage demonstrated by a transepidermal water loss (TEWL) value of ≥12 g/h/m² and a skin hydration value below 35 (Corneometer measurement)
  • Individuals who provided voluntary informed consent
  • Those who agreed to comply with study visits and observations

排除标准

  • Individuals with active skin diseases requiring treatment
  • Those with an ESIF score >6
  • Individuals with a history of antibiotic, steroid, immunosuppressant, antihistamine, or retinoid use, or phototherapy within the last 4 weeks
  • Individuals who used skin disease-related supplements or moisturizers within 2 weeks
  • Those participating in other clinical trials within the last 4 weeks
  • Individuals with frequent exposure to UV light
  • Pregnant or lactating women
  • Those planning pregnancy during the trial period
  • Any other factors deemed unsuitable by the investigator

研究组 & 干预措施

Arm 1: LP-51

Experimental

test substance was applied on participants

干预措施: Microbiome Therapeutic LP-51 (Biological)

Arm 2: Placebo

Placebo Comparator

cream without active substance (M23004-03) was applied on the participants

干预措施: placebo cream (M23004-03) (Other)

结局指标

主要结局

Improvement of skin hydration and transepidermal water loss, and relieving pruritus

时间窗: From enrollment to the end of treatment at 4 weeks

A 4-week double-blind clinical trial involving 43 participants suffering from xerosis was conducted to evaluate the therapeutic potential of Microbiome therapeutic LP51. To serve this purpose, Lactobarriome 5% cream containing LP51 culture filtrate was applied on the dry skin for 4-week. A random allocation chart (Simple Randomization method) was used to assign participants to the experimental group (test formulation) or control group (placebo). The volunteers applied the product twice daily (morning and evening) to a 3 cm area proximal and distal to the crook of the designated arm. Clinical parameters were evaluated at baseline, after 2 weeks, and after 4 weeks of use. Visual assessments, subjective pruritus evaluations, skin hydration measurements, and TEWL measurements were conducted at every visit by a skin professional. Additionally, magnified photographs were taken using a Folliscope, and skin samples were collected to assess microbial changes after treatment.

次要结局

未报告次要终点

研究者

发起方
Ho-Yeon Song
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ho-Yeon Song

Professor

Soon Chun Hyang University

研究点 (1)

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