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

ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-35
SponsorFoundation University Islamabad

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Probiotics
  • Placebo

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Foundation University Islamabad

Lead sponsor

Fauji Foundation Hospital

Collaborator