NCT07366229 Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne
| NCT ID | NCT07366229 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shenzhen People's Hospital |
| Condition | Acne |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 196 participants in total. It began in 2025-12-30 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07366229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 33 Years, studying Acne. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07366229 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07366229 currently recruiting?
Yes, NCT07366229 is actively recruiting participants. Contact the research team at zhang.jianglin@szgospital.com for enrollment information.
Where is the NCT07366229 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07366229 clinical trial?
NCT07366229 is sponsored by Shenzhen People's Hospital. The trial plans to enroll 196 participants.