Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT07266532
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Lactobacillus Crispatus for Skin Barrier Dysfunction in Obesity
Sponsor:
Shenzhen People's Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: