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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

A Randomized Controlled Trial Investigating the Efficacy of Oral Probiotics Versus Placebo in Pakistani Patients With Moderate Acne on Acne Lesion Count and Systemic Inflammation (Interleukin-6) Levels

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07539129
Acronym
Acne vulgaris
Enrollment
64
Registered
2026-04-20
Start date
2026-09-01
Completion date
2027-08-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris, Modrate Acne, Probiotics, Inflammatory markers, Interleukin 6, Ecotec TM

Brief 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.

Detailed description

This randomized placebo-controlled trial evaluated the effectiveness of oral probiotics in patients with moderate acne vulgaris in Pakistan. Acne is a chronic inflammatory condition of the pilosebaceous unit with multifactorial pathogenesis involving sebum overproduction, follicular hyperkeratinization, microbial colonization, and inflammation. Conventional therapies, particularly antibiotics, are increasingly limited by resistance, prompting exploration of alternative treatments. Emerging evidence suggests a link between gut microbiota and skin inflammation, supporting the potential role of probiotics in acne management. A total of 64 patients aged 18-35 years with moderate acne were enrolled and randomly assigned to receive either oral probiotic sachets or placebo once daily for 12 weeks. The probiotic preparation contained multiple strains including Lactobacillus and Bifidobacterium species. Baseline assessment included lesion counts, Global Acne Grading System scoring, and serum interleukin-6 levels. Follow-up evaluations were conducted at regular intervals to monitor clinical response, compliance, and adverse effects. The primary outcome was reduction in total acne lesion count, while the secondary outcome was change in systemic inflammation measured by IL-6 levels. Blood samples were collected at baseline and at the end of treatment for cytokine analysis using ELISA. Standardized skincare was maintained for all participants to minimize confounding factors. Data were analyzed using appropriate statistical tests, with significance set at p ≤ 0.05. Ethical approval was obtained, and informed consent was secured from all participants. The study aimed to determine whether probiotics could provide a safe and effective adjunct or alternative to conventional acne therapies by reducing both clinical severity and systemic inflammation.

Interventions

DIETARY_SUPPLEMENTProbiotics

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.

OTHERPlacebo

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

Foundation University Islamabad
Lead SponsorOTHER
Fauji Foundation Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The study is assessor-blinded: participants are aware of the assigned treatment (oral probiotic or placebo), but the investigator assessing outcomes (acne lesion count, GAGS score, and IL-6 levels will be blinded to group allocation.

Intervention model description

This is a parallel-group randomized controlled trial. Participants with moderate acne vulgaris will be randomly assigned to either oral probiotics vs oral placebo

Eligibility

Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Mean reduction in total acne lesion count12 weeksReduction in total acne lesion count from baseline to 12 weeks, assessed using standardized lesion counting and Global Acne Grading System (GAGS).

Secondary

MeasureTime frameDescription
Mean reduction in serum Interleukin-6 (IL-6) levelsBaseline to 12 weeksChange in serum IL-6 levels from baseline to Week 12, measured using ELISA. Greater reduction indicates decreased systemic inflammation.

Countries

Pakistan

Contacts

CONTACTDr. Aima Tariq, FCPS, Fellowship in Derma
aimatariq1@gmail.com+923359844189
CONTACTDr. Arfan ul Bari, FCPS Derma
albariul@gmail.com+923016547007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026