Evaluation of the Safety and Efficacy of Topical Application of Lactobacillus Crispatuson the Forearm for Treating Obesity-Induced Skin Barrier Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter
研究概览
简要总结
This clinical trial aims to evaluate the safety and efficacy of topical application of Lactobacillus crispatuson the forearm for treating obesity-induced skin barrier impairment in individuals aged 18-45 with BMI ≥25. The study focuses on the following questions:
Can topical application of Lactobacillus crispatusreduce skin barrier damage, as measured by transepidermal water loss (TEWL), in obese participants?
Does modulation of the skin microbiota with Lactobacillus crispatusimprove skin barrier function, hydration, and reduce local inflammation?
Is the topical intervention safe and well-tolerated, with minimal adverse effects?
Preliminary data from obese volunteers and mouse models revealed significantly elevated TEWL and reduced Lactobacillusabundance in the skin microbiome of obese individuals, supporting the investigation of probiotic restoration.
Researchers will compare outcomes across two groups:
Intervention Group (Obese) : Daily topical application of active Lactobacillus crispatussolution (1×10⁷ CFU in 3 mL) to a 3-cm diameter area on both forearms.
Placebo Control Group (Obese) : Daily topical application of inactivated Lactobacillus crispatussolution (identical appearance and volume).
Participant Procedures:
Apply the assigned topical solution daily to the forearm for 4 weeks.
Undergo non-invasive skin testing, including TEWL measurements and skin hydration assessments, at baseline and study completion (Week 4).
Provide skin swab samples at baseline and Week 4 for microbiome analysis (16S rRNA sequencing) and inflammation marker detection (e.g., IL-1β, TNF-α via ELISA).
Complete weekly check-ins to report adverse effects (e.g., skin irritation, erythema) and adherence, with follow-ups at Weeks 1, 2, and 3.
Maintain a daily electronic or paper diary to record application time, dose, and any skin reactions.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Meets 2020 WHO BMI classification:
- •a. Normal weight (18.5-24.9 kg/m²)
- •b. Overweight (25-29.9 kg/m²)
- •c. Obesity (≥30 kg/m²)
- •2. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
- •3. Age 18-40 years
- •4. Generally good health (no active systemic diseases)
- •5. Able and willing to provide written informed consent
- •6. No use of oral/topical medications or probiotics within 6 months prior
- •7. No active skin disease or traumatic skin lesions
排除标准
- •1. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
- •2. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
- •3. Severe medical conditions:
- •a. Cardiopulmonary disease (NYHA class III/IV)
- •b. Uncontrolled diabetes (HbA1c >9%)
- •c. Autoimmune disorders
- •4. Pregnant or breastfeeding women
- •5. Any condition that may interfere with protocol compliance (per investigator judgement), including:
- •a. Inability to understand study procedures
- •b. History of poor clinical trial adherence
- •6. Concurrent participation in other interventional trials
研究组 & 干预措施
Topical L. crispatus Treatment Group
干预措施: Topical L. crispatus Treatment Group (Biological)
Topical Inactivated Lactobacillus crispatus Application Group
干预措施: Topical Inactivated Lactobacillus crispatus Application Group (Biological)
结局指标
主要结局
Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter
时间窗: Baseline through 1 month after intervention
TEWL will be assessed on the volar aspect of the forearm using a Tewameter device under standardized environmental conditions (controlled temperature and humidity). At each time point, TEWL will be measured at three predefined skin sites on the volar forearm, and the average value will be used. The primary outcome will be the mean change in TEWL (g/h/m²) from baseline (Day 0) to 1 month after intervention. Lower TEWL values indicate improved skin barrier function.
次要结局
- Change in skin hydration measured by Corneometer(Baseline through 1 month after intervention)
- Change in clinical skin health score(Baseline through 1 month after intervention)
- Change in body weight and BMI(Baseline through 1 month after intervention)