Natural History of Injectable Permanent Synthetic Filler Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorResearch Inc
About this trial
Injectable permanent synthetic filler disease is characterized by heterogeneous local and systemic manifestations that may emerge years after filler injection. Although inflammatory reactions, migration, foreign-body granulomas, adipose tissue injury, fat necrosis, and fibrosis have been individually described, the temporal clinicopathologic evolution of the disease remains poorly characterized.
This prospective observational cohort study aims to characterize the natural history of disease associated with injectable permanent synthetic fillers by integrating time since injection, clinical manifestations, magnetic resonance imaging findings, and histopathologic tissue features. Participants with a history of gluteal injection of permanent synthetic fillers who undergo clinical evaluation, magnetic resonance imaging, and clinically indicated surgical removal of affected tissue will be evaluated. Histopathologic findings will be systematically assessed for adipose tissue injury, acute and chronic inflammation, foreign-body granulomatous reaction, fat necrosis, fibrosis, characteristics of the exogenous material, and vascular or lymphatic involvement.
The primary objective is to determine how histopathologic disease patterns vary according to time since injection. Secondary objectives include evaluating temporal associations with clinical symptoms, extent of migration on magnetic resonance imaging, fibrosis, granulomatous inflammation, and evidence of superimposed inflammatory reactivation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with a documented history of injection of permanent synthetic or modeling substances into the gluteal region.
Disqualifiers
Exposure exclusively to temporary or resorbable fillers without evidence of permanent synthetic filler exposure.
Trial population
The study population consists of consecutive adult patients evaluated at a tertiary referral center for complications associated with prior gluteal injection of permanent synthetic fillers. Participants undergo prospective clinical evaluation and magnetic resonance imaging as part of their clinical assessment and subsequently undergo clinically indicated surgical removal of affected tissue, allowing histopathologic characterization of the disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
450 Participants
are grouped into 1 trial groupGroup A: Injectable Permanent Synthetic Filler Disease Cohort
Trial outcomes
Primary outcomes
1
Temporal Pattern of Histopathologic Tissue Injury
Predefined histopathologic features will be assessed according to the time elapsed since filler injection. Features will include adipose tissue injury, acute inflammatory activity, chronic inflammation, foreign-body giant-cell and granulomatous reaction, fat necrosis, and fibrosis. The primary analysis will evaluate the association between disease duration, modeled primarily as a continuous variable, and the distribution and severity of these histopathologic findings.
Time frame
At surgical tissue sampling; disease duration measured from filler injection to surgical tissue collection. 1 weekSecondary outcomes
1
Clinical Symptom Burden According to Disease Duration
Local and systemic symptoms documented during prospective clinical assessment will be characterized according to time since filler injection. Individual symptoms and overall symptom burden will be evaluated.
Time frame
1 year2
Foreign-Body Granulomatous Inflammation
The presence and severity of histiocytic inflammation, multinucleated foreign-body giant cells, and granulomatous reaction will be evaluated histopathologically and analyzed in relation to disease duration.
Time frame
At surgical tissue sampling. 1 week3
Severity and Pattern of Fibrosis
Fibrosis will be assessed according to severity and morphologic distribution, including diffuse, perivacuolar, or capsular patterns when identifiable. Features of mature, hyalinized, fragmented, or disrupted fibrosis will also be recorded.
Time frame
At surgical tissue sampling. 1 week4
Histopathologic Evidence of Superimposed Inflammatory Reactivation
The coexistence of mature or longstanding fibrosis with superimposed acute inflammatory activity will be evaluated. The association between disrupted or fragmented fibrotic compartments and acute inflammatory findings will be assessed as a potential morphologic correlate of inflammatory reactivation.
Time frame
At surgical tissue sampling; 1 weekSponsors and contacts
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Source ClinicalTrials.gov