NCT07266532Completed
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
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 25 Nov 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 15 Dec 2025
- Lead sponsor
- Shenzhen People's Hospital
- Diseases
- Obesity
- NCT number
- NCT07266532
What you commit to
- Study type: Interventional
- Participants enrolled: 98
- From 15 Dec 2025 to the primary completion date, 15 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
- 6\. Concurrent participation in other interventional trials
Other illness
- 2\. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
- 3\. Severe medical conditions:
- a. Cardiopulmonary disease (NYHA class III/IV)
- c. Autoimmune disorders
- 5\. Any condition that may interfere with protocol compliance (per investigator judgement), including:
- b. History of poor clinical trial adherence
Lab values
- b. Uncontrolled diabetes (HbA1c \>9%)
Other
- 4\. Pregnant or breastfeeding women
- a. Inability to understand study procedures
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.