Acne VulgarisFACEMICRONCT07834138
Facial Skin Microbiome in Patients With Moderate-to-Severe Acne Vulgaris Treated With Isotretinoin
An observational study of Acne Vulgaris, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ISOtretinoin 10 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Jan 2026to 7 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- Acne Vulgaris Cohort:
- 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.
- Willingness to participate in the study.
Show all 11Show fewer
- Healthy Control Cohort:
- Voluntary participation in the study.
- No history or clinical manifestations of acne vulgaris.
- No use of antibiotics or isotretinoin within the previous 6 months.
- No lesions of other skin diseases on the face.
Who cannot join
- 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.
- Use of facial cleansing products or topical medications within 24 hours before sample collection.
- History of allergy.
- Unwillingness to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Can Tho University of Medicine and Pharmacy Hospital
Can Tho
Tram Thi Bao Pham, MD, 84 0366100 241, ptbtram@ctump.edu.vn
About this study
Official title: 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
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.
Read the detailed description
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.
This 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.
Facial 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.
Clinical 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.
The 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.
Study 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.
- Conditions
- Acne Vulgaris
- Being tested
- ISOtretinoin 10 MG
- Keywords
- Skin microbiome, Facial microbiome, Isotretinoin, 16S rRNA sequencing, Cutibacterium acnes, Bacterial diversity, Microbial dysbiosis
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISOtretinoin 10 MGDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ISOtretinoin 10 MG | |
| Healthy Control Cohort | Healthy volunteers without acne vulgaris who provide baseline facial skin samples for comparison with the acne vulgaris cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, before isotretinoin treatment in the acne cohort
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.
Measured: Baseline to Week 20
Secondary outcomes (19)
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.
Measured: 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.
Measured: Baseline to Week 20
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.
Measured: 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.
Measured: Baseline
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.
Measured: baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline to Week 20
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.
Measured: Baseline to Week 20
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.
Measured: Baseline to Week 20
Change in Simpson Diversity Index From Baseline to Week 20
Change in the Simpson diversity index of the facial skin microbiome from baseline to Week 20 in participants receiving oral isotretinoin.
Measured: Baseline to Week 20
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.
Measured: Baseline to Week 20
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.
Measured: Baseline to Week 20
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.
Measured: Baseline to Week 20
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.
Measured: Baseline to Week 20
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.
Measured: Baseline to Week 20
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.
Measured: Baseline to Week 20
Clinical Response Rate to Isotretinoin at Week 20
Proportion of participants classified as having good, fair, moderate, or poor/no clinical improvement after 20 weeks of oral isotretinoin treatment. Good, fair, moderate, and poor/no improvement are defined according to the predefined clinical response criteria in the study protocol.
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start13 Jan 2026
- Primary completion7 Feb 2027 (estimated)
- Study completion7 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834138
- Sponsor's protocol ID
- 25.0020.NCS-ĐHYDCT
- Acronym
- FACEMICRO
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07834138
- Acronym / sponsor ID
- FACEMICRO / 25.0020.NCS-ĐHYDCT
- Conditions
- Acne Vulgaris
- Keywords
- Skin microbiome, Facial microbiome, Isotretinoin, 16S rRNA sequencing, Cutibacterium acnes, Bacterial diversity, Microbial dysbiosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 7 Feb 2027 (estimated)
- Study completion
- 7 Mar 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This 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.
Facial 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.
Clinical 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.
The 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.
Study 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acne Vulgaris Cohort | – | Drug: ISOtretinoin 10 MGParticipants 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 |
| Healthy Control Cohort | – | –Healthy volunteers without acne vulgaris who provide baseline facial skin samples for comparison with the acne vulgaris cohort. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- 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.
- Willingness to participate in the study.
Key exclusion criteria (7 listed)
- 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.
- Use of facial cleansing products or topical medications within 24 hours before sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISOtretinoin 10 MGOral isotretinoin administered as part of routine clinical care according to institutional treatment protocols. The study does not assign or modify isotretinoin treatment; investigators prospectively | Drug | Acne Vulgaris Cohort |
Primary outcome
Shannon-Wiener Diversity Index of the Facial Skin Microbiome at Baseline
Time frame: At baseline, before isotretinoin treatment in the acne cohort
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
Time frame: Baseline to Week 20
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.
19 secondary outcomes
Relative Abundance and Taxonomic Composition of the Facial Skin Microbiome
Time frame: Baseline
Change in Simpson Diversity Index During Isotretinoin Treatmen
Time frame: Baseline to Week 20
Chao1 Richness Index of the Facial Skin Microbiome at Baseline
Time frame: Baseline
ACE Richness Index of the Facial Skin Microbiome at Baseline
Time frame: Baseline
Jaccard Distance of the Facial Skin Microbiome at Baseline
Time frame: baseline
Bray-Curtis Dissimilarity of the Facial Skin Microbiome at Baseline
Time frame: Baseline
Unweighted UniFrac Distance of the Facial Skin Microbiome at Baseline
Time frame: Baseline
Weighted UniFrac Distance of the Facial Skin Microbiome at Baseline
Time frame: Baseline
Change in Relative Abundance of Bacterial Taxa at the Phylum Level From Baseline to Week 20
Time frame: Baseline to Week 20
Change in Relative Abundance of Bacterial Taxa at the Genus Level From Baseline to Week 20
Time frame: Baseline to Week 20
Change in the Number of Amplicon Sequence Variants Detected From Baseline to Week 20
Time frame: Baseline to Week 20
Change in Simpson Diversity Index From Baseline to Week 20
Time frame: Baseline to Week 20
Change in Chao1 Richness Index From Baseline to Week 20
Time frame: Baseline to Week 20
Change in ACE Richness Index From Baseline to Week 20
Time frame: Baseline to Week 20
Change in Jaccard Distance From Baseline to Week 20
Time frame: Baseline to Week 20
Change in Bray-Curtis Dissimilarity From Baseline to Week 20
Time frame: Baseline to Week 20
Change in Unweighted UniFrac Distance From Baseline to Week 20
Time frame: Baseline to Week 20
Change in Weighted UniFrac Distance From Baseline to Week 20
Time frame: Baseline to Week 20
Clinical Response Rate to Isotretinoin at Week 20
Time frame: Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tram Thi Bao Pham (84 0366 100 241, ptbtram@ctump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shannon-Wiener Diversity Index of the Facial Skin Microbiome at Baseline (time frame: At baseline, before isotretinoin treatment in the acne cohort). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.