NCT07366229

Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne

Evaluating Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne: A Double-Blind, Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 33 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acne

Interventions

Type	Name	Description
BIOLOGICAL	MPN-coated engineered Lactobacillus reuteri cream	Each night before bedtime, after washing the face, an appropriate amount of MPN-coated engineered Lactobacillus reuteri cream should be applied topically to acne lesions using a sterile cotton swab. The area should not be washed immediately after application. Normal face washing can be resumed the following morning. This regimen should be continued for 2 weeks.
BIOLOGICAL	Plain Lactobacillus reuteri cream	Each night before bedtime, after washing the face, an appropriate amount of plain Lactobacillus reuteri cream should be applied topically to acne lesions using a sterile cotton swab. The area should not be washed immediately after application. Normal face washing can be resumed the following morning. This regimen should be continued for 2 weeks.
DRUG	Petrolatum-glycerin cream	Each night before bedtime, after washing the face, an appropriate amount of petrolatum-glycerin cream should be applied topically to acne lesions using a sterile cotton swab. The area should not be washed immediately after application. Normal face washing can be resumed the following morning. This regimen should be continued for 2 weeks.
DRUG	Tretinoin cream 0.1%	Each night before bedtime, after washing the face, an appropriate amount of 0.1% tretinoin cream should be applied topically to acne lesions using a sterile cotton swab. The area should not be washed immediately after application. Normal face washing can be resumed the following morning. This regimen should be continued for 2 weeks.

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-03-30
• Completion: 2026-06-30
• First posted: 2026-01-26
• Last updated: 2026-04-06

Locations

1 site across 1 country: China