AcnePhase 2NCT07366229
Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne
A Phase 2 study testing MPN-coated engineered Lactobacillus reuteri cream, Plain Lactobacillus reuteri cream and Petrolatum-glycerin cream in people with Acne, run by Shenzhen People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 33 years
- Conditions the study is for
- Acne
- What is being tested?
- MPN-coated engineered Lactobacillus reuteri cream, Plain Lactobacillus reuteri cream and Petrolatum-glycerin cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 33 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Shenzhen People's Hospital, +86 75522943881, 195323995@qq.com
About this study
Official title: Evaluating Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne: A Double-Blind, Randomized Controlled Trial
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.
Read more
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
- Being tested
- MPN-coated engineered Lactobacillus reuteri cream, Plain Lactobacillus reuteri cream, Petrolatum-glycerin cream, Tretinoin cream 0.1%
- Keywords
- acne, Lactobacillus reuteri
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPN-coated engineered Lactobacillus reuteri creamBiological
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.
Plain Lactobacillus reuteri creamBiological
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.
Petrolatum-glycerin creamDrug
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.
Tretinoin cream 0.1%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Apply the MPN-coated engineered Lactobacillus reuteri cream to acne lesions once daily for 2 weeks. Receives: Biological: MPN-coated engineered Lactobacillus reuteri cream |
| Positive Control Group | Active comparator | Apply the 0.1% tretinoin cream to acne lesions once daily for 2 weeks. Receives: Drug: Tretinoin cream 0.1% |
| Negative Control Group | Placebo comparator | Apply the petrolatum-glycerin cream to acne lesions once daily for 2 weeks. Receives: Drug: Petrolatum-glycerin cream |
| Control Group | Other | Apply the plain Lactobacillus reuteri cream to acne lesions once daily for 2 weeks. Receives: Biological: Plain Lactobacillus reuteri cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in acne count at Week 8 relative to the baseline.
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%.
Measured: 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.
Secondary outcomes (3)
Percentage change in the number of inflammatory acne lesions at Week 8 relative to the baseline
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 inflammatory acne lesions from these photographs. The percentage change in the number of inflammatory acne lesions at Week 8 relative to the baseline is calculated as: (Number of inflammatory acne lesions at Week 8 - Number of inflammatory acne lesions at baseline) / Number of inflammatory acne lesions at baseline × 100%.
Measured: 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 patients are taken before treatment and at Weeks 1, 2, 4, and 8 after the initial treatment. Dermatologists count the number of non-inflammatory acne lesions from these photographs. The percentage change in the number of non-inflammatory acne lesions at Week 8 relative to the baseline is calculated as: (Number of non-inflammatory acne lesions at Week 8 - Number of non-inflammatory acne lesions at baseline) / Number of non-inflammatory acne lesions at baseline × 100%.
Measured: 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 before treatment and at Weeks 1, 2, 4, and 8 after the initial treatment. These samples are subjected to 16S rRNA gene sequencing to detect the presence and relative abundance of various bacterial taxa in the affected areas following the intervention.
Measured: Skin microbiome samples are collected from acne lesions at baseline and at Weeks 1, 2, 4, and 8 after the initial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start30 Dec 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Group Intervention: Apply the MPN-coated engineered Lactobacillus reuteri cream to acne lesions once daily for 2 weeks. Control Group Intervention: Apply the plain Lactobacillus reuteri cream to acne lesions once daily for 2 weeks. Negative Control Group Intervention: Apply the petrolatum-glycerin cream to acne lesions once daily for 2 weeks. Positive Control Group Intervention: Apply the 0.1% tretinoin cream to acne lesions once daily for 2 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366229
- Sponsor's protocol ID
- LL-KY-2025172-02
- Status last verified
- Dec 2025
- First submitted
- 17 Jan 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07366229
- Acronym / sponsor ID
- LL-KY-2025172-02
- Conditions
- Acne
- Keywords
- acne, Lactobacillus reuteri
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Experimental Group Intervention: Apply the MPN-coated engineered Lactobacillus reuteri cream to acne lesions once daily for 2 weeks. Control Group Intervention: Apply the plain Lactobacillus reuteri cream to acne lesions once daily for 2 weeks. Negative Control Group Intervention: Apply the petrolatum-glycerin cream to acne lesions once daily for 2 weeks. Positive Control Group Intervention: Apply the 0.1% tretinoin cream to acne lesions once daily for 2 weeks.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: MPN-coated engineered Lactobacillus reuteri creamApply the MPN-coated engineered Lactobacillus reuteri cream to acne lesions once daily for 2 weeks. |
| Positive Control Group | Active comparator | Drug: Tretinoin cream 0.1%Apply the 0.1% tretinoin cream to acne lesions once daily for 2 weeks. |
| Negative Control Group | Placebo comparator | Drug: Petrolatum-glycerin creamApply the petrolatum-glycerin cream to acne lesions once daily for 2 weeks. |
| Control Group | Other | Biological: Plain Lactobacillus reuteri creamApply the plain Lactobacillus reuteri cream to acne lesions once daily for 2 weeks. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPN-coated engineered Lactobacillus reuteri creamEach 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 | Experimental Group |
| Plain Lactobacillus reuteri creamEach 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. | Biological | Control Group |
| Petrolatum-glycerin creamEach 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 | Negative Control Group |
| 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. | Drug | Positive Control Group |
Primary outcome
Percentage change in acne count at Week 8 relative to the baseline.
Time frame: 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%.
3 secondary outcomes
Percentage change in the number of inflammatory acne lesions at Week 8 relative to the baseline
Time frame: 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
Time frame: 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
Time frame: Skin microbiome samples are collected from acne lesions at baseline and at Weeks 1, 2, 4, and 8 after the initial treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MPN-coated engineered Lactobacillus reuteri cream, Plain Lactobacillus reuteri cream and Petrolatum-glycerin cream in people with Acne, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianglin Zhang (+86 13873143466, zhang.jianglin@szgospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in acne count at Week 8 relative to the baseline. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.