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Facial Skin Microbiome in Patients With Moderate-to-Severe Acne Vulgaris Treated With Isotretinoin

Study acronym: FACEMICRO
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Eligibility criteria revised
  2. Minor Secondary endpoints: 7 to 19
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07834138
Lead Sponsor Can Tho University of Medicine and Pharmacy
Conditions
(from sponsor)
Acne Vulgaris
Related terms Acne Vulgaris
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov