Acne vulgaris is associated with changes in the facial skin microbiome, but longitudinal microbiome changes during isotretinoin therapy remain incompletely understood. This prospective observational cohort study aims to characterize the facial skin microbiome in patients with moderate-to-severe acne vulgaris before and during isotretinoin treatment and to compare microbiome profiles with healthy individuals.
Participants with moderate-to-severe acne vulgaris receiving standard-of-care oral isotretinoin will be followed prospectively. Facial skin swab samples will be collected before treatment and at scheduled follow-up visits during therapy. Healthy volunteers without acne will provide a single facial skin swab for comparison. Bacterial communities will be analyzed using 16S rRNA gene sequencing, and clinical severity will be assessed using validated acne severity scores and lesion counts.
The study will evaluate changes in microbial diversity, bacterial composition, and the relative abundance of acne-associated microorganisms during isotretinoin treatment. Associations between microbiome changes and clinical improvement will also be explored. Results are expected to improve understanding of the role of the skin microbiome in acne and provide evidence for future microbiome-based therapeutic strategies.
Participants aged 16-35 years.
Clinical diagnosis of acne vulgaris.
Presence of acne lesions on both cheeks.
Indication for oral isotretinoin treatment according to clinical assessment at Can Tho University of Medicine and Pharmacy Hospital.
Current dermatologic diseases such as rosacea, contact dermatitis, eczema, or psoriasis.
Current acute or chronic medical diseases.
Use of antibiotics or isotretinoin within the previous 3 months.
Use of phototherapy or topical probiotics on the facial skin within the previous 3 months.
The study population consists of participants aged 16 to 35 years recruited at Can Tho University of Medicine and Pharmacy Hospital. The study includes patients with acne vulgaris who are indicated for oral isotretinoin treatment and healthy volunteers without acne vulgaris. The acne cohort is followed prospectively during isotretinoin treatment, while the healthy control group is assessed at baseline for comparison of facial skin microbiome characteristics.
Cohort
Prospective
ISOtretinoin 10 MG
DrugOral isotretinoin administered as part of routine clinical care according to institutional treatment protocols. The study does not assign or modify isotretinoin treatment; investigators prospectively
Shannon-Wiener Diversity Index of the Facial Skin Microbiome at Baseline
Difference in the Shannon-Wiener diversity index of the facial skin microbiome between participants with moderate-to-severe acne vulgaris and healthy controls at baseline.
Change in Shannon-Wiener Diversity Index of the Facial Skin Microbiome During Isotretinoin Treatment
Change in the Shannon-Wiener diversity index of the facial skin microbiome from baseline to after 20 weeks of isotretinoin treatment in participants with moderate-to-severe acne vulgaris.
Relative Abundance and Taxonomic Composition of the Facial Skin Microbiome
Comparison of bacterial community composition at the phylum and genus levels between the acne vulgaris and healthy control cohorts at baseline.
Change in Simpson Diversity Index During Isotretinoin Treatmen
Change in the Simpson diversity index of the facial skin microbiome from baseline to Week 20 in participants receiving oral isotretinoin.
Chao1 Richness Index of the Facial Skin Microbiome at Baseline
Comparison of the Chao1 richness index of the facial skin microbiome between the acne vulgaris and healthy control cohorts at baseline.
ACE Richness Index of the Facial Skin Microbiome at Baseline
Comparison of the ACE richness index of the facial skin microbiome between the acne vulgaris and healthy control cohorts at baseline.
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