Clinical Trial

Investigating the Efficacy of Oral Probiotics Versus Placebo in Pakistani Patients With Moderate Acne on Acne Lesion Count and Systemic Inflammation

Study acronym: Acne vulgaris
Not Yet Recruiting
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Summary
This randomized controlled trial evaluates the efficacy of oral probiotics compared to placebo in Pakistani patients with moderate Acne Vulgaris. Acne is a multifactorial inflammatory disorder influenced by microbial colonization, seborrhea, and immune dysregulation. Rising antibiotic resistance necessitates alternative therapeutic approaches. Emerging evidence highlights the gut-skin axis, suggesting probiotics may reduce systemic inflammation and acne severity. A total of 64 patients will be randomized into probiotic and placebo groups and treated for 12 weeks. The primary outcome is reduction in total acne lesion count, while the secondary outcome is change in serum Interleukin-6 levels. Clinical assessment includes lesion counts, GAGS scoring, and standardized photography. IL-6 levels will be measured using ELISA at baseline and study completion. Data will be analyzed using SPSS with appropriate statistical tests, considering p ≤ 0.05 as significant. This study aims to provide evidence for probiotics as a safe, effective, and antibiotic-sparing option in acne management, particularly in South Asian populations.
Trial Details
NCT Number NCT07539129
Lead Sponsor Foundation University Islamabad
Collaborators: Fauji Foundation Hospital
Conditions Acne Vulgaris
Enrollment 64 participants
Start Date 2026-09-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-20