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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

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
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112125
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-11-17
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-infectious skin diseases

Interventions

Lactobacillus crispatus smear test group:Once daily, 3mL of Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles
Inactive Lactobacillus crispatus smear controls:Once daily, 3mL of inactive Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles

Sponsors

Shenzhen People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. meet the 2020 World Health Organization (WHO) criteria for obesity classification: normal weight: BMI 18.5-24.9 kg/m^2; Overweight: BMI 25-29.9 kg/m^2; Obesity: BMI >= 30 kg/m^2, no duration limitation; 2. Skin barrier damage (such as dry skin, erythema, desquamation, pruritus, etc.); 3. patients' informed consent and voluntary participation; Signing informed consent; 4. aged 18-45 years with good general health; 5. not using drugs that affect the skin barrier (such as hormones and immunosuppressants) within 3 months ", and clearly "allowing the use of drugs for underlying diseases that do not affect the skin (such as antihypertensive drugs and hypoglycemic drugs); 6. no skin disease or trauma.

Exclusion criteria

Exclusion criteria: 1. history of allergy or allergy to probiotics, placebo, or study drug; 2. patients with active skin disease or other serious diseases; 3. pregnant or lactating women; 4. use of drugs that may affect skin barrier function (such as hormone drugs, immunosuppressants, etc.); 5. other circumstances considered by the investigator to be inappropriate for subject inclusion, such as the subject being untrustworthy, unacceptable, or unable to understand the evaluator of the study.

Design outcomes

Primary

MeasureTime frame
Transepidermal water loss rate of forearm skin;

Secondary

MeasureTime frame
Skin hydration;Skin health score;Analysis of the skin microbiota;Body Weight and BMI;Detection of Inflammatory Factors;Assessment of Quality of Life;

Countries

China

Contacts

Public ContactJianglin Zhang

Shenzhen People’s Hospital (The First Affiliated Hospital, Southern University of Science and Techno )

zhang.jianglin@szhospital.com+86 138 7314 3466

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026