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Effect of oral probiotics in conjunction with topical benzoyl peroxide on the acne skin microbiome

Effect of oral probiotics in conjunction with topical benzoyl peroxide on the acne skin microbiome

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250218013
Enrollment
63
Registered
2025-02-18
Start date
2025-03-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients who have mild to moderate acne vulgaris Acne vulgaris, probiotics, microbiome, microbiota, benzoyl peroxide

Interventions

oral probiotics 500 mg once daily and topical 2.5% benzoyl peroxide twice daily,oral placebo once daily and topical 2.5% benzoyl peroxide twice daily,oral probiotics 500 mg once daily and topical plac
Active Comparator Drug,Placebo Comparator Drug,Experimental Drug
oral probiotics and topical 2.5% benzoyl peroxide,oral placebo and topical 2.5% benzoyl peroxide,oral probiotics and topical placebo

Sponsors

Strategic Wisdom and Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients who diagnosed with mild to moderate acne vulgaris, 2. Aged 18 years or older, 3. No underlying medical conditions, 4. Able to attend scheduled medical appointments, 5. Willing to participate in the research voluntarily and provide written informed consent by signing the Informed Consent Form

Exclusion criteria

Exclusion criteria: 1. Presence of other dermatological conditions on the face, including drug-induced acne, psoriasis, atopic dermatitis, skin infections, and contact dermatitis., 2. Pregnant or breastfeeding women., 3. Individuals with a history of using any of the following topical medications within two weeks prior to joining the study: Anti-inflammatory medications, such as all types of topical corticosteroids. Acne treatments, including benzoyl peroxide at any concentration and topical formulations containing silver nanoparticles. Antibiotics, such as topical erythromycin and topical clindamycin. Topical retinoids. Skin-lightening agents, including alpha hydroxy acid (AHA), beta hydroxy acid (BHA), alpha arbutin, and azelaic acid. Localized injectable treatments, such as tranexamic acid (transamine)., 4. Individuals who have taken any of the following systemic medications within six weeks prior to the study: Anti-inflammatory drugs, including all types of oral corticosteroids. Acne-related treatments, such as oral zinc supplementation. Antibiotics. Skin-lightening agents, such as oral tranexamic acid (transamine). Antioxidants, including oral vitamin C, oral vitamin E, and astaxanthin., 5. Individuals who have taken systemic retinoids, such as isotretinoin, within six months before the study., 6. Individuals with a history of allergy to lactic acid., 7. Individuals with a history of allergy to probiotics., 8. Individuals who have regularly consumed probiotics or yogurt daily within three months prior to the study (washout period required).

Design outcomes

Primary

MeasureTime frame
alpha diversity, beta diversity and taxonomy (relative abundant of bacterial species and genus) 3 months after first use of the intervention observe ASVs, Chao1 (richness), Shannon (evenness), scattering plot / Wilcoxon, Kruskal Wallis test

Secondary

MeasureTime frame
Correlation between microbiome composition and treatment response 3 months after first use of the intervention relative abundant of genus and species

Countries

Thailand

Contacts

Public ContactSalinee Rojhirunsakool

Faculty of Medicine, Srinakharinwirot University

salinee.roj@gmail.com0894159665

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026