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

Southern University of Science and Technology

Status and phase: Not yet enrolling; Phase 2

Conditions: Acne

Treatments: Biological: MPN-coated engineered Lactobacillus reuteri cream; Drug: Petrolatum-glycerin cream; Biological: Plain Lactobacillus reuteri cream; Drug: Tretinoin cream 0.1%

Study type: Interventional

Funder types: Other

Identifiers

NCT07366229

LL-KY-2025172-02

Details and patient eligibility

About

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. We 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 33 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Subjects must be willing and able to provide written informed consent.
3. Subjects must be 18 to 33 years of age and in generally good health.
4. Subjects must have more than 9 inflammatory lesions.

Exclusion criteria

1. Have used antibiotics within 1 month before the study start.
2. Have used systemic retinoid therapy within 3 months before the study start.
3. Have undergone any other acne treatment within 1 month before the study start.
4. 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 4 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

Apply the MPN-coated engineered Lactobacillus reuteri cream to acne lesions once daily for 2 weeks.

Treatment:

Biological: MPN-coated engineered Lactobacillus reuteri cream

Positive Control Group

Active Comparator group

Description:

Apply the 0.1% tretinoin cream to acne lesions once daily for 2 weeks.

Treatment:

Drug: Tretinoin cream 0.1%

Negative Control Group

Placebo Comparator group

Description:

Apply the petrolatum-glycerin cream to acne lesions once daily for 2 weeks.

Treatment:

Drug: Petrolatum-glycerin cream

Control Group

Other group

Description:

Apply the plain Lactobacillus reuteri cream to acne lesions once daily for 2 weeks.

Treatment:

Biological: Plain Lactobacillus reuteri cream