Natural history of injectable permanent synthetic filler disease in adults
Official title: Prospective Clinical, Magnetic Resonance Imaging, and Histopathologic Characterization of the Natural History of Injectable Permanent Synthetic Filler Disease
Run by Research Inc · NCT07867353 · Data updated 2026-11-12
This study follows adults who had permanent injectable fillers in the buttocks to see how their symptoms and tissue changes develop over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 450 (estimated) |
| Sponsor | Research Inc Industry-sponsored |
| Locations | 1 site (Medellín, Antioquia) |
| Status | Recruiting |
| Started | January 22, 2020 |
| Main results expected | October 2, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07867353 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a documented history of gluteal injections of permanent synthetic fillers who are undergoing clinically indicated surgical tissue removal and have available MRI.
✕Probably not a fit
Individuals without a history of permanent fillers or without planned tissue removal may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study collects clinical, imaging, and histopathologic data from adults with a history of gluteal permanent synthetic fillers who undergo tissue removal. The goal is to map how disease manifestations evolve with the time since injection by integrating presentation, MRI findings, and tissue features. Researchers will analyze adipose injury, inflammation, granulomas, and fibrosis across different durations to identify reproducible disease states. The study does not assign treatments and uses existing clinical procedures to gather data. Findings may clarify the natural history of this condition and inform future management approaches.
Why it matters
Potential benefit: Better understanding of how permanent filler disease progresses could improve diagnosis and guide future treatment decisions.
How similar studies have gone: Previous reports describe diverse clinical and histopathologic features of the condition, but systematic longitudinal characterization is limited, making this study relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with a documented history of injection of permanent synthetic or modeling substances into the gluteal region. Available date or sufficiently reliable estimated date of filler injection to determine disease duration. Prospective clinical assessment documenting local and/or systemic manifestations. Available magnetic resonance imaging of the affected anatomical region performed as part of clinical evaluation. Clinically indicated surgical removal of affected tissue. Histopathologic tissue specimen available and of sufficient quality for standardized review. Availability of the core clinical, radiologic, and histopathologic variables required for the primary analysis. Written informed consent when required by the approved research protocol. Exclusion Criteria: * Exposure exclusively to temporary or resorbable fillers without evidence of permanent synthetic filler exposure. Inability to determine the approximate date of filler injection. Histopathologic specimens insufficient for standardized evaluation. Magnetic resonance imaging unavailable or technically inadequate for assessment of disease distribution. Incomplete core clinical data preventing evaluation of the prespecified study outcomes. Previous complete surgical removal of the injected material before the index clinical and imaging assessment, when this prevents reconstruction of the untreated disease state.
Where it's running
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Clinica Bioforma
Medellín, Antioquia, Colombia Recruiting
Study contacts
- Study coordinator: Edison Osorio, MD, Plastic surgeon
- Email: info@edisonosorio.com
- Phone: +573226140611
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.