Topical Lactobacillus Crispatus for Skin Barrier Dysfunction in Obesity

NCT07266532 | Completed

• 1 other identifier: LL-KY-2025229-02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Skin Barrier to Water Loss; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline through 1 month after intervention

Secondary Outcomes (3)

• Change in skin hydration measured by Corneometer

  Baseline through 1 month after intervention

• Change in clinical skin health score

  Baseline through 1 month after intervention

• Change in body weight and BMI

  Baseline through 1 month after intervention

Study Arms (2)

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

Interventions

Topical Inactivated Lactobacillus crispatus Application Group BIOLOGICAL

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 Inactivated Lactobacillus crispatus Application Group

Topical L. crispatus Treatment Group BIOLOGICAL

Once daily, 3mL of Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles

Topical L. crispatus Treatment Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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)
• \. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
• \. Age 18-40 years
• \. Generally good health (no active systemic diseases)
• \. Able and willing to provide written informed consent
• \. No use of oral/topical medications or probiotics within 6 months prior
• \. No active skin disease or traumatic skin lesions

You may not qualify if:

• \. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
• \. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
• \. Severe medical conditions:
• a. Cardiopulmonary disease (NYHA class III/IV)
• b. Uncontrolled diabetes (HbA1c \>9%)
• c. Autoimmune disorders
• \. Pregnant or breastfeeding women
• \. 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
• \. Concurrent participation in other interventional trials

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: December 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)