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Oral Probiotics vs Placebo Pakistani Moderate Acne Study

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Summary

ClinicalTrials.gov registered a randomized controlled trial (NCT07539129) evaluating oral probiotics versus placebo in 64 Pakistani patients with moderate Acne Vulgaris over 12 weeks. The primary endpoint is reduction in total acne lesion count; secondary endpoint is change in serum Interleukin-6 levels. The study will use GAGS scoring and standardized photography for clinical assessment.

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What changed

This document registers a clinical trial (NCT07539129) investigating oral probiotics as an alternative to antibiotics for moderate acne, reflecting interest in the gut-skin axis. The trial will enroll 64 patients randomized to probiotic or placebo groups for 12 weeks of treatment.

For compliance purposes, this study registration does not create immediate obligations. However, clinical research sponsors, contract research organizations, and investigators conducting dermatology or microbiome research should note this trial as a registered investigation that may inform future regulatory submissions or publication of results, which could influence review of probiotic-based or antibiotic-sparing dermatology therapies.

Archived snapshot

Apr 20, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

N/A NCT07539129 Kind: NA Apr 20, 2026

Abstract

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.

Conditions: Acne Vulgaris

Interventions: Probiotics, Placebo

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial design Patient randomization Clinical assessment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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