[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657146":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":81,"studyPopulation":82,"armGroups":83,"interventions":92,"overallOfficials":77,"centralContacts":98,"locations":104,"responsibleParty":121,"collaborators":77,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":77,"studyType":138,"phases":77,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":107,"whyStopped":77,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Can Tho University of Medicine and Pharmacy","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":77},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","At baseline, before isotretinoin treatment in the acne cohort",{"measure":14,"description":15,"timeFrame":16},"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.","Baseline to Week 20",[18,22,25,28,31,35,38,41,44,47,50,53,55,58,61,64,67,70,73],{"measure":19,"description":20,"timeFrame":21},"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.","Baseline",{"measure":23,"description":24,"timeFrame":16},"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.",{"measure":26,"description":27,"timeFrame":21},"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.",{"measure":29,"description":30,"timeFrame":21},"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.",{"measure":32,"description":33,"timeFrame":34},"Jaccard Distance of the Facial Skin Microbiome at Baseline","Comparison of Jaccard distance of the facial skin microbiome between the acne vulgaris and healthy control cohorts at baseline.","baseline",{"measure":36,"description":37,"timeFrame":21},"Bray-Curtis Dissimilarity of the Facial Skin Microbiome at Baseline","Comparison of Bray-Curtis dissimilarity of the facial skin microbiome between the acne vulgaris and healthy control cohorts at baseline.",{"measure":39,"description":40,"timeFrame":21},"Unweighted UniFrac Distance of the Facial Skin Microbiome at Baseline","Comparison of unweighted UniFrac distance of the facial skin microbiome between the acne vulgaris and healthy control cohorts at baseline.",{"measure":42,"description":43,"timeFrame":21},"Weighted UniFrac Distance of the Facial Skin Microbiome at Baseline","Comparison of weighted UniFrac distance of the facial skin microbiome between the acne vulgaris and healthy control cohorts at baseline.",{"measure":45,"description":46,"timeFrame":16},"Change in Relative Abundance of Bacterial Taxa at the Phylum Level From Baseline to Week 20","Change in the relative abundance of bacterial taxa at the phylum level in facial skin microbiome samples from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":48,"description":49,"timeFrame":16},"Change in Relative Abundance of Bacterial Taxa at the Genus Level From Baseline to Week 20","Change in the relative abundance of bacterial taxa at the genus level in facial skin microbiome samples from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":51,"description":52,"timeFrame":16},"Change in the Number of Amplicon Sequence Variants Detected From Baseline to Week 20","Change in the number of amplicon sequence variants detected in facial skin microbiome samples from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":54,"description":24,"timeFrame":16},"Change in Simpson Diversity Index From Baseline to Week 20",{"measure":56,"description":57,"timeFrame":16},"Change in Chao1 Richness Index From Baseline to Week 20","Change in the Chao1 richness index of the facial skin microbiome from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":59,"description":60,"timeFrame":16},"Change in ACE Richness Index From Baseline to Week 20","Change in the ACE richness index of the facial skin microbiome from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":62,"description":63,"timeFrame":16},"Change in Jaccard Distance From Baseline to Week 20","Change in Jaccard distance of the facial skin microbiome from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":65,"description":66,"timeFrame":16},"Change in Bray-Curtis Dissimilarity From Baseline to Week 20","Change in Bray-Curtis dissimilarity of the facial skin microbiome from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":68,"description":69,"timeFrame":16},"Change in Unweighted UniFrac Distance From Baseline to Week 20","Change in unweighted UniFrac distance of the facial skin microbiome from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":71,"description":72,"timeFrame":16},"Change in Weighted UniFrac Distance From Baseline to Week 20","Change in weighted UniFrac distance of the facial skin microbiome from baseline to Week 20 in participants receiving oral isotretinoin.",{"measure":74,"description":75,"timeFrame":76},"Clinical Response Rate to Isotretinoin at Week 20","Proportion of participants classified as having good, fair, moderate, or poor\u002Fno clinical improvement after 20 weeks of oral isotretinoin treatment. Good, fair, moderate, and poor\u002Fno improvement are defined according to the predefined clinical response criteria in the study protocol.","Week 20",null,{"allocation":77,"interventionModel":77,"interventionModelDescription":77,"primaryPurpose":77,"observationalModel":79,"timePerspective":80,"maskingInfo":77},"COHORT","PROSPECTIVE","Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit and is one of the most common dermatologic disorders worldwide. Increasing evidence suggests that acne is associated with alterations in the composition and diversity of the skin microbiome rather than the presence of a single pathogenic microorganism. However, longitudinal changes in the facial skin microbiome during isotretinoin treatment have not been fully characterized in Southeast Asian populations.\n\nThis study is a prospective observational cohort conducted in Vietnam. The study includes two participant groups: patients with moderate-to-severe acne vulgaris and healthy volunteers without acne. Patients receive oral isotretinoin according to routine clinical practice and institutional treatment protocols. The study does not assign or modify treatment; investigators prospectively observe clinical and microbiome changes during routine care.\n\nFacial skin samples are collected using standardized skin swab procedures from predefined facial sites. Samples are processed for bacterial DNA extraction and 16S rRNA gene sequencing to characterize microbial communities. Sequencing data are analyzed using bioinformatics pipelines for taxonomic classification and diversity analysis.\n\nClinical assessments include validated acne severity grading systems, inflammatory and non-inflammatory lesion counts, and evaluation of treatment response during follow-up. Healthy volunteers provide baseline microbiome samples for comparison with acne participants before treatment.\n\nThe primary objective is to characterize longitudinal changes in the facial skin microbiome during isotretinoin treatment in patients with moderate-to-severe acne vulgaris. Secondary objectives include comparing baseline microbiome characteristics between acne patients and healthy individuals and exploring associations between microbiome composition and clinical treatment outcomes.\n\nStudy findings may contribute to a better understanding of microbiome dynamics during isotretinoin therapy and provide a foundation for future microbiome-targeted approaches in acne management.","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.",[84,89],{"label":85,"type":77,"description":86,"interventionNames":87},"Acne Vulgaris Cohort","Participants with moderate-to-severe acne vulgaris who are receiving oral isotretinoin as part of routine clinical care and are followed prospectively for clinical and facial skin microbiome changes",[88],"Drug: ISOtretinoin 10 MG",{"label":90,"type":77,"description":91,"interventionNames":77},"Healthy Control Cohort","Healthy volunteers without acne vulgaris who provide baseline facial skin samples for comparison with the acne vulgaris cohort.",[93],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":77},"DRUG","ISOtretinoin 10 MG","Oral isotretinoin administered as part of routine clinical care according to institutional treatment protocols. The study does not assign or modify isotretinoin treatment; investigators prospectively",[85],[99],{"name":100,"role":101,"phone":102,"phoneExt":77,"email":103},"Tram Thi Bao Pham","CONTACT","84 0366 100 241","ptbtram@ctump.edu.vn",[105],{"facility":106,"status":107,"city":108,"state":77,"zip":77,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"Can Tho University of Medicine and Pharmacy Hospital","RECRUITING","Can Tho","Vietnam","VN",{"type":112,"coordinates":113},"Point",[114,115],105.78825,10.03711,{"lat":115,"lon":114},[118],{"name":119,"role":101,"phone":120,"phoneExt":77,"email":103},"Tram Thi Bao Pham, MD","84 0366100 241",{"type":122,"investigatorFullName":77,"investigatorTitle":77,"investigatorAffiliation":77,"oldNameTitle":77,"oldOrganization":77},"SPONSOR","100657146","facial-skin-microbiome-in-patients-with-moderate-to-severe-acne-vulgaris-treated-with-isotretinoin-100657146",false,"NCT07834138","Facial Skin Microbiome in Patients With Moderate-to-Severe Acne Vulgaris Treated With Isotretinoin","Clinical Characteristics and Longitudinal Changes in the Facial Skin Microbiome of Patients With Moderate-to-Severe Acne Vulgaris Treated With Isotretinoin: A Prospective Cohort Study","FACEMICRO","Inclusion Criteria:\n\nAcne Vulgaris Cohort:\n\n* Participants aged 16-35 years.\n* Clinical diagnosis of acne vulgaris.\n* Presence of acne lesions on both cheeks.\n* Indication for oral isotretinoin treatment according to clinical assessment at Can Tho University of Medicine and Pharmacy Hospital.\n* Willingness to participate in the study.\n\nHealthy Control Cohort:\n\n* Voluntary participation in the study.\n* No history or clinical manifestations of acne vulgaris.\n* No use of antibiotics or isotretinoin within the previous 6 months.\n* No lesions of other skin diseases on the face.\n\nExclusion Criteria:\n\n* Current dermatologic diseases such as rosacea, contact dermatitis, eczema, or psoriasis.\n* Current acute or chronic medical diseases.\n* Use of antibiotics or isotretinoin within the previous 3 months.\n* Use of phototherapy or topical probiotics on the facial skin within the previous 3 months.\n* Use of facial cleansing products or topical medications within 24 hours before sample collection.\n* History of allergy.\n* Unwillingness to participate in the study.",true,"ALL","16 Years","35 Years",{"count":136,"type":137},90,"ESTIMATED","OBSERVATIONAL","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.\n\nParticipants 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.\n\nThe 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.",[141],"Acne Vulgaris",[143,144,145,146,147,148,149],"Skin microbiome","Facial microbiome","Isotretinoin","16S rRNA sequencing","Cutibacterium acnes","Bacterial diversity","Microbial dysbiosis","2026-09-30",{"date":152,"type":153},"2026-10-01","ACTUAL",{"date":155,"type":153},"2026-01-13",{"date":157,"type":137},"2027-03-07",{"name":5,"class":6},1]