Efficacy and Safety of Oral Probiotics in Severe Acne Vulgaris

Efficacy and Safety of Oral Probiotics in Severe Acne Vulgaris - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/109892

Enrollment

Registered

2026-05-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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 Capsule Isotretinoin 20mg (Group A): Group A Oral Capsule Isotretinoin 20mg OD daily for 16 weeks Control Intervention1: Capsule Isotretinoin 20 mg and Oral Probiotic capsule (Gro

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 18-30 years 2.Patients having moderate to severe acne vulgaris (Nodular/ with scarring/recalcitrant moderate) according to the global acne grading system 3.The patient who gives written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients with known psychiatric illness, hyperlipidemia, hepatic disease 2.Hormonal acne 3.Other grades of acne: mild acne, acne conglobata, acne fulminans, predominantly comedonal 4.Drug-induced, cosmetic, occupational acne, mechanical acne, acne excoriee 5.Associated with other facial dermatoses like rosacea, topical steroid-dependent face, dermatitis, melasma, folliculitis, demodicosis, etc., which can influence assessment 6.Any systemic illness or immunosuppression 7.Any hypersensitivity or drug interaction to the study molecules 8.Pregnant and lactating females or planning pregnancy 9.History of topical acne treatment, systemic acne treatment, systemic probiotic treatment in the past one month and h/o systemic isotretinoin treatment in the past 3 months

Design outcomes

Primary

Measure	Time frame
1.Improvement in GAGS score and Investigator s Global Assessment (IGA)/comprehensive acne severity system score 2.Number and percentage of patients who improve to at least one grade in the GAGS score 3.Mean and percentage reduction of the total number of acne lesions, inflammatory and non-inflammatory lesions Timepoint: At Baseline, week 4, week 8, week 12 and week 16	—

Secondary

Measure	Time frame
1.Number of patients with 50% or more reduction in inflammatory lesions 2.Number of patients achieving IGA (0-1) 3.Time to achieve a 50% reduction in inflammatory lesion count 4.Comparison of the number of patients having flares after starting the drug in both groups 5.Quality of life by CADI score at baseline and at the end of treatment 6.Patient Satisfaction score 7.Adverse effects in both groups 8.Qualitative skin Microbiome assessment at baseline and at the end of treatment 9.Serum TNF alpha at baseline and at the end of treatmenTimepoint: At Baseline, week 4, week 8, week 12 and week 16	—

Measure

Time frame

1.Number of patients with 50% or more reduction in inflammatory lesions 2.Number of patients achieving IGA (0-1) 3.Time to achieve a 50% reduction in inflammatory lesion count 4.Comparison of the number of patients having flares after starting the drug in both groups 5.Quality of life by CADI score at baseline and at the end of treatment 6.Patient Satisfaction score 7.Adverse effects in both groups 8.Qualitative skin Microbiome assessment at baseline and at the end of treatment 9.Serum TNF alpha at baseline and at the end of treatmenTimepoint: At Baseline, week 4, week 8, week 12 and week 16

—

Countries

India

Contacts

Public ContactDr Anupama Bains

All India Institute of Medical Sciences, Jodhpur

doc.trinity@yahoo.com7297895713

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026