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Effect of oral probiotic and prebiotic supplements added to standard acne creams on acne severity in people with mild to moderate acne

Efficacy and safety of oral symbiotic supplementation as an adjunct to topical benzoyl peroxide and adapalene in mild to moderate acne vulgaris: a randomized control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099143
Enrollment
80
Registered
2025-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: Oral symbiotic supplementation will be administered as an add-on therapy to the standard topical treatment regimen (Benzoyl Peroxide 2.5% + Adapalene 0.1%).: Participants in this group

Sponsors

Pt BD Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either gender aged 12 to 35 years. 2.Clinical diagnosis of mild to moderate acne vulgaris (based on GAGS). 3.Willing to provide written informed consent (and assent for minors).

Exclusion criteria

Exclusion criteria: 1.Known hypersensitivity to any of the study drugs. 2.Pregnant or lactating females, or those planning pregnancy during the study period. 3.Patients with severe nodulocystic acne. 4.Use of systemic or topical anti-acne medications within the past 3 months. 5.Psychiatric or psychosocial conditions affecting study compliance. 6.Significant medical conditions (e.g., uncontrolled diabetes, liver or kidney disease).

Design outcomes

Primary

MeasureTime frame
1. Reduction in Global Acne Grading System (GAGS) score 2. Reduction in inflammatory and non-inflammatory lesions by the lesion count method Timepoint: 1.Reduction in Global Acne Grading System (GAGS) score, assessed at baseline, 4th week, 8th week, and 12th week. 2.Reduction in inflammatory and non-inflammatory acne lesions, measured by the lesion count method at baseline, 4th week, 8th week, and 12th week.—

Secondary

MeasureTime frame
1. Reduction in Cardiff Acne Disability Index (CADI) score 2. Improvement in quality of life, by using the Dermatology Life Quality Index (DLQI) score. Timepoint: Participants will be assessed initially during enrollment for baseline parameters and will be followed up at the 12-week visit for assessment of the Cardiff Acne Disability Index (CADI) score and the Dermatology Life Quality Index (DLQI) score.—

Countries

India

Contacts

Public ContactDr Nikita Jha

Pt B. D Sharma PGIMS, Rohtak

nikita.jha1009@gmail.com7608936504

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026