Facial skin microbiome changes during isotretinoin in moderate-to-severe acne
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
Run by Can Tho University of Medicine and Pharmacy · NCT07834138 · Data updated 2026-11-12
This study tests how the facial skin microbiome changes in people with moderate-to-severe acne who are treated with isotretinoin, and compares them with healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years to 35 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Can Tho University of Medicine and Pharmacy Academic / other |
| Locations | 1 site (Can Tho) |
| Status | Recruiting |
| Started | January 13, 2026 |
| Main results expected | February 7, 2027 |
| Study ends | March 7, 2027 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07834138 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 16–35-year-old individuals with moderate-to-severe acne vulgaris scheduled to receive isotretinoin and who consent to serial skin sampling; healthy controls without acne are also included.
✕Probably not a fit
Patients who do not experience microbiome changes or who do not respond to isotretinoin may not show microbiome benefits in this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort conducted in Vietnam. It follows patients with moderate-to-severe acne receiving isotretinoin and collects facial skin swabs before treatment and at follow-up visits to analyze microbiome changes using 16S rRNA sequencing. A healthy control group provides a single baseline skin sample for comparison. Clinical acne severity, lesion counts, and treatment response are tracked alongside microbiome data. The study does not alter standard care; it observes microbiome dynamics during routine isotretinoin therapy.
Why it matters
Potential benefit: If successful, the study could clarify how isotretinoin relates to shifts in facial bacteria and identify microbiome patterns associated with treatment response.
How similar studies have gone: Previous work suggests microbiome alterations occur with acne and treatment, but longitudinal data during isotretinoin, especially in Southeast Asian populations, are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: * 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.
Where it's running
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Can Tho University of Medicine and Pharmacy Hospital
Can Tho, Vietnam Recruiting
Study contacts
- Study coordinator: Tram Thi Bao Pham
- Email: ptbtram@ctump.edu.vn
- Phone: 84 0366 100 241
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.