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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT07539129

Run by

Foundation University Islamabad

People needed

64

Starts

2026-09-01

Expected to finish

2027-08-01

Last updated by the study team

2026-04-20

Who can join

Age: 15 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients aged 15-35 years
• Clinical diagnosis of moderate acne vulgaris
• Fitzpatrick skin types III-V
• Willing to provide informed consent and comply with study protocol

You may not qualify if…

• Severe nodulocystic acne, acne conglobata, or acne fulminans
• Oral antibiotics, isotretinoin, or hormonal therapy within past 4 weeks
• Topical anti-acne therapy within past 2 weeks
• Current probiotic supplementation
• Chronic inflammatory or autoimmune disease
• Pregnancy or lactation

Where it is running

• Fauji Foundation Hospital, Rawalpindi — Rawalpindi, Punjab Province, Pakistan

Full record on ClinicalTrials.gov

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