Evaluating Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne: A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Percentage change in acne count at Week 8 relative to the baseline.
研究概览
简要总结
A growing body of evidence suggests that the development and progression of acne are closely linked to an imbalance in the skin's microbial community. Compared to healthy skin, the composition and function of the microbiota in acne lesions are significantly altered. This microbial imbalance is believed to drive the formation and recurrence of acne through mechanisms such as triggering abnormal inflammatory responses and compromising the skin barrier.
An in-depth exploration of the interaction between acne and the skin microbiome not only offers new perspectives for understanding the root causes of the disease but also lays the groundwork for developing novel treatment strategies aimed at modulating the microbiota. Therefore, identifying innovative approaches that integrate acne treatment with the regulation of microbial balance holds significant clinical and social value.
Although existing acne treatments have made progress, research focusing on interventions that regulate the local skin microecology through probiotics remains relatively limited. This study aims to explore a new strategy based on skin microecological modulation. Investigators are using a common probiotic-Lactobacillus reuteri-and applying an engineering modification with a special coating formed by zinc sulfate and tannic acid (MPN coating). This modification is intended to enhance the bacterium's survival and colonization on the skin, thereby more effectively regulating the local microbiota and reducing inflammation.
This study is a rigorous scientific clinical trial designed as randomized, double-blind, and controlled. Eligible participants will be randomly assigned to one of four groups, receiving either the engineered Lactobacillus reuteri cream, the plain Lactobacillus reuteri cream, a simple moisturizing cream (placebo), or an already-marketed effective cream (tretinoin cream). The treatment will last for 2 weeks, followed by an 8-week observation period. Efficacy and safety will be evaluated through professional assessments.
Our goal is to scientifically evaluate the safety and efficacy of this new therapy, hoping to provide a potential new treatment option for individuals with acne and explore new pathways for improving skin health.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 33 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be diagnosed with acne (based on history, clinical manifestation, and dermatoscopy) and classified as Grade I to III per the International Improved Grading System.
- •Subjects must be willing and able to provide written informed consent.
- •Subjects must be 18 to 33 years of age and in generally good health.
- •Subjects must have more than 9 inflammatory lesions.
排除标准
- •Have used antibiotics within 1 month before the study start.
- •Have used systemic retinoid therapy within 3 months before the study start.
- •Have undergone any other acne treatment within 1 month before the study start.
- •Have any other condition that the investigator considers would make participation unsuitable (e.g., deemed unreliable, non-compliant, or unable to comprehend the study assessments).
研究组 & 干预措施
Experimental Group
Apply the MPN-coated engineered Lactobacillus reuteri cream to acne lesions once daily for 2 weeks.
干预措施: MPN-coated engineered Lactobacillus reuteri cream (Biological)
Positive Control Group
Apply the 0.1% tretinoin cream to acne lesions once daily for 2 weeks.
干预措施: Tretinoin cream 0.1% (Drug)
Negative Control Group
Apply the petrolatum-glycerin cream to acne lesions once daily for 2 weeks.
干预措施: Petrolatum-glycerin cream (Drug)
Control Group
Apply the plain Lactobacillus reuteri cream to acne lesions once daily for 2 weeks.
干预措施: Plain Lactobacillus reuteri cream (Biological)
结局指标
主要结局
Percentage change in acne count at Week 8 relative to the baseline.
时间窗: Facial photographs of the patients will be taken at baseline and at Weeks 1, 2, 4, and 8 after the initial treatment, and the number of acne lesions will be counted by dermatologists.
Facial photographs of patients are taken before treatment and at Weeks 1, 2, 4, and 8 after the initial treatment. Dermatologists count the number of acne lesions from these photographs. The percentage change in acne count at Week 8 relative to the baseline is calculated as: (Acne count at Week 8 - Acne count at baseline) / Acne count at baseline × 100%.
次要结局
- Percentage change in the number of inflammatory acne lesions at Week 8 relative to the baseline(Facial photographs of the patients will be taken at baseline and at Weeks 1, 2, 4, and 8 after the initial treatment, and the number of inflammatory acne lesions will be counted by dermatologists.)
- Percentage change in the number of non-inflammatory acne lesions at Week 8 relative to the baseline(Facial photographs of the patients will be taken at baseline and at Weeks 1, 2, 4, and 8 after the initial treatment, and the number of non-inflammatory acne lesions will be counted by dermatologists.)
- Changes in the relative abundance of Propionibacterium, Lactobacillus, and Staphylococcus in acne-prone skin from baseline to Week 8(Skin microbiome samples are collected from acne lesions at baseline and at Weeks 1, 2, 4, and 8 after the initial treatment.)