NCT07266532

Topical Lactobacillus Crispatus for Skin Barrier Dysfunction in Obesity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Topical Inactivated Lactobacillus crispatus Application Group	Once 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 L. crispatus Treatment Group	Once daily, 3mL of Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles

Timeline

• Start date: 2025-12-15
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2025-12-05
• Last updated: 2025-12-24

Locations

1 site across 1 country: China