Engineered Lactobacillus reuteri cream with 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
This trial will test whether a topical cream containing engineered Lactobacillus reuteri with a zinc sulfate–tannic acid coating can reduce inflammatory acne in adults aged 18–33.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years to 33 Years |
| Sex | All |
| Sponsor | Shenzhen People's Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07366229 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial applies a topical engineered Lactobacillus reuteri formulation with an MPN zinc sulfate–tannic acid coating and compares it to plain Lactobacillus reuteri cream, a petrolatum-glycerin vehicle, and tretinoin 0.1% cream. Participants who meet inclusion criteria receive one of the topical treatments and are followed over a defined treatment period with clinical acne grading and lesion counts. The study also examines changes in the skin microbiome to determine whether shifting microbial balance correlates with clinical response. Safety, tolerability, and local skin effects are monitored throughout the trial.
Who should consider this trial
Good fit: Adults 18 to 33 years old with Grade I–III acne and more than nine inflammatory lesions who can give informed consent and are generally healthy.
Not a fit: People with recent antibiotic or systemic retinoid use, those who had other acne treatments within one month, or those with acne outside Grade I–III are less likely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could provide a non-antibiotic, microbiome-targeted topical option that lowers inflammatory lesions and reduces acne recurrence.
How similar studies have performed: Topical probiotic approaches have shown mixed but promising results for acne, while the use of engineered Lactobacillus reuteri with an MPN coating is a novel strategy that has not been proven in large trials yet.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Shenzhen, Guangdong
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jianglin Zhang
- Email: zhang.jianglin@szgospital.com
- Phone: +86 13873143466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.