Skin Barrier to Water LossNCT07266532
Topical Lactobacillus Crispatus for Skin Barrier Dysfunction in Obesity
A study testing Topical Inactivated Lactobacillus crispatus Application Group and Topical L. crispatus Treatment Group in people with Skin Barrier to Water Loss and Microbial Colonization, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the safety and efficacy of topical application of Lactobacillus crispatuson the forearm for treating obesity-induced skin barrier impairment in individuals aged 18-45 with BMI ≥25. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Barrier to Water Loss, Microbial Colonization
- What is being tested?
- Topical Inactivated Lactobacillus crispatus Application Group and Topical L. crispatus Treatment Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Meets 2020 WHO BMI classification:
- a. Normal weight (18.5-24.9 kg/m²)
- b. Overweight (25-29.9 kg/m²)
- c. Obesity (≥30 kg/m²)
- 2. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
- 3. Age 18-40 years
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- 4. Generally good health (no active systemic diseases)
- 5. Able and willing to provide written informed consent
- 6. No use of oral/topical medications or probiotics within 6 months prior
- 7. No active skin disease or traumatic skin lesions
Who cannot join
- 1. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
- 2. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
- 3. Severe medical conditions:
- a. Cardiopulmonary disease (NYHA class III/IV)
- b. Uncontrolled diabetes (HbA1c >9%)
- c. Autoimmune disorders
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- 4. Pregnant or breastfeeding women
- 5. Any condition that may interfere with protocol compliance (per investigator judgement), including:
- a. Inability to understand study procedures
- b. History of poor clinical trial adherence
- 6. Concurrent participation in other interventional trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of Topical Application of Lactobacillus Crispatuson the Forearm for Treating Obesity-Induced Skin Barrier Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
This clinical trial aims to evaluate the safety and efficacy of topical application of Lactobacillus crispatuson the forearm for treating obesity-induced skin barrier impairment in individuals aged 18-45 with BMI ≥25. The study focuses on the following questions:
Can topical application of Lactobacillus crispatusreduce skin barrier damage, as measured by transepidermal water loss (TEWL), in obese participants?
Read more
Does modulation of the skin microbiota with Lactobacillus crispatusimprove skin barrier function, hydration, and reduce local inflammation?
Is the topical intervention safe and well-tolerated, with minimal adverse effects?
Preliminary data from obese volunteers and mouse models revealed significantly elevated TEWL and reduced Lactobacillusabundance in the skin microbiome of obese individuals, supporting the investigation of probiotic restoration.
Researchers will compare outcomes across two groups:
Intervention Group (Obese) : Daily topical application of active Lactobacillus crispatussolution (1×10⁷ CFU in 3 mL) to a 3-cm diameter area on both forearms.
Placebo Control Group (Obese) : Daily topical application of inactivated Lactobacillus crispatussolution (identical appearance and volume).
Participant Procedures:
Apply the assigned topical solution daily to the forearm for 4 weeks.
Undergo non-invasive skin testing, including TEWL measurements and skin hydration assessments, at baseline and study completion (Week 4).
Provide skin swab samples at baseline and Week 4 for microbiome analysis (16S rRNA sequencing) and inflammation marker detection (e.g., IL-1β, TNF-α via ELISA).
Complete weekly check-ins to report adverse effects (e.g., skin irritation, erythema) and adherence, with follow-ups at Weeks 1, 2, and 3.
Maintain a daily electronic or paper diary to record application time, dose, and any skin reactions.
- Conditions
- Skin Barrier to Water Loss, Microbial Colonization
- Being tested
- Topical Inactivated Lactobacillus crispatus Application Group, Topical L. crispatus Treatment Group
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Inactivated Lactobacillus crispatus Application GroupBiological
Once daily, 3mL of inactive Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles
Topical L. crispatus Treatment GroupBiological
Once daily, 3mL of Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles
| Study group | Role | What they receive |
|---|---|---|
| Topical L. crispatus Treatment Group | Experimental | Not described Receives: Biological: Topical L. crispatus Treatment Group |
| Topical Inactivated Lactobacillus crispatus Application Group | Sham comparator | Not described Receives: Biological: Topical Inactivated Lactobacillus crispatus Application Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter
TEWL will be assessed on the volar aspect of the forearm using a Tewameter device under standardized environmental conditions (controlled temperature and humidity). At each time point, TEWL will be measured at three predefined skin sites on the volar forearm, and the average value will be used. The primary outcome will be the mean change in TEWL (g/h/m²) from baseline (Day 0) to 1 month after intervention. Lower TEWL values indicate improved skin barrier function.
Measured: Baseline through 1 month after intervention
Secondary outcomes (3)
Change in skin hydration measured by Corneometer
Skin hydration will be assessed using a Corneometer device. Outcomes will be expressed as mean skin capacitance values (arbitrary units) at baseline and post-intervention.
Measured: Baseline through 1 month after intervention
Change in clinical skin health score
Skin dryness, scaling, erythema, itching, and allergy-related symptoms will be evaluated using a standardized Skin Dryness Scoring System. Data will be reported as mean score change from baseline.
Measured: Baseline through 1 month after intervention
Change in body weight and BMI
Participants' body weight (kg) and BMI (kg/m²) will be recorded at baseline and post-intervention. Data will be reported as mean change.
Measured: Baseline through 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Dec 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Barrier to Water LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
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
- NCT07266532
- Sponsor's protocol ID
- LL-KY-2025229-02
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Topical Application of Lactobacillus Crispatuson the Forearm for Treating Obesity-Induced Skin Barrier Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07266532
- Acronym / sponsor ID
- LL-KY-2025229-02
- Conditions
- Skin Barrier to Water Loss, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 5 Dec 2025 (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.
This clinical trial aims to evaluate the safety and efficacy of topical application of Lactobacillus crispatuson the forearm for treating obesity-induced skin barrier impairment in individuals aged 18-45 with BMI ≥25. The study focuses on the following questions:
Can topical application of Lactobacillus crispatusreduce skin barrier damage, as measured by transepidermal water loss (TEWL), in obese participants?
Does modulation of the skin microbiota with Lactobacillus crispatusimprove skin barrier function, hydration, and reduce local inflammation?
Is the topical intervention safe and well-tolerated, with minimal adverse effects?
Preliminary data from obese volunteers and mouse models revealed significantly elevated TEWL and reduced Lactobacillusabundance in the skin microbiome of obese individuals, supporting the investigation of probiotic restoration.
Researchers will compare outcomes across two groups:
Intervention Group (Obese) : Daily topical application of active Lactobacillus crispatussolution (1×10⁷ CFU in 3 mL) to a 3-cm diameter area on both forearms.
Placebo Control Group (Obese) : Daily topical application of inactivated Lactobacillus crispatussolution (identical appearance and volume).
Participant Procedures:
Apply the assigned topical solution daily to the forearm for 4 weeks.
Undergo non-invasive skin testing, including TEWL measurements and skin hydration assessments, at baseline and study completion (Week 4).
Provide skin swab samples at baseline and Week 4 for microbiome analysis (16S rRNA sequencing) and inflammation marker detection (e.g., IL-1β, TNF-α via ELISA).
Complete weekly check-ins to report adverse effects (e.g., skin irritation, erythema) and adherence, with follow-ups at Weeks 1, 2, and 3.
Maintain a daily electronic or paper diary to record application time, dose, and any skin reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical L. crispatus Treatment Group | Experimental | Biological: Topical L. crispatus Treatment Group |
| Topical Inactivated Lactobacillus crispatus Application Group | Sham comparator | Biological: Topical Inactivated Lactobacillus crispatus Application Group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 1. Meets 2020 WHO BMI classification:
- a. Normal weight (18.5-24.9 kg/m²)
- b. Overweight (25-29.9 kg/m²)
- c. Obesity (≥30 kg/m²)
- 2. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
Key exclusion criteria (11 listed)
- 1. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
- 2. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
- 3. Severe medical conditions:
- a. Cardiopulmonary disease (NYHA class III/IV)
- b. Uncontrolled diabetes (HbA1c >9%)
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 |
|---|---|---|
| Topical Inactivated Lactobacillus crispatus Application GroupOnce daily, 3mL of inactive Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles | Biological | Topical Inactivated Lactobacillus crispatus Application Group |
| Topical L. crispatus Treatment GroupOnce daily, 3mL of Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles | Biological | Topical L. crispatus Treatment Group |
Primary outcome
Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter
Time frame: Baseline through 1 month after intervention
TEWL will be assessed on the volar aspect of the forearm using a Tewameter device under standardized environmental conditions (controlled temperature and humidity). At each time point, TEWL will be measured at three predefined skin sites on the volar forearm, and the average value will be used. The primary outcome will be the mean change in TEWL (g/h/m²) from baseline (Day 0) to 1 month after intervention. Lower TEWL values indicate improved skin barrier function.
3 secondary outcomes
Change in skin hydration measured by Corneometer
Time frame: Baseline through 1 month after intervention
Change in clinical skin health score
Time frame: Baseline through 1 month after intervention
Change in body weight and BMI
Time frame: Baseline through 1 month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Inactivated Lactobacillus crispatus Application Group and Topical L. crispatus Treatment Group in people with Skin Barrier to Water Loss and Microbial Colonization, 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 10 inclusion and 11 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: finished, as of the sponsor's last update on 24 Dec 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter (time frame: Baseline through 1 month after intervention). 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 24 Dec 2025.