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

NCT07539129 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Acne Vulgaris

Interventions

DIETARY_SUPPLEMENT

Probiotics

Participants will receive a standardized multi-strain oral probiotic (Ecotec sachet) once daily for 12 weeks alongside standard acne care. The formulation contains Lactobacillus and Bifidobacterium species aimed at modulating the gut-skin axis and reducing systemic inflammation.

OTHER

Placebo

Participants will receive a placebo sachet identical in appearance, taste, and packaging to the probiotic, administered once daily for 12 weeks alongside standard acne care. The placebo contains inert ingredients with no active probiotic strains, ensuring blinding and allowing accurate comparison of treatment outcomes.

Sponsors & Collaborators

  • Fauji Foundation Hospital

    collaborator OTHER

  • Foundation University Islamabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-06-01
Completion
2027-08-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07539129 on ClinicalTrials.gov