An observational study in Complications of Injectable Permanent Synthetic Fillers, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Research Inc · Observational
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.
Permanent synthetic filler disease represents a heterogeneous clinicopathologic condition associated with the injection of persistent exogenous materials for body contouring. Individual manifestations including adipose tissue injury, chronic inflammation, foreign-body granuloma formation, fibrosis, and local or regional migration have been described; however, the relationship between these findings and the duration of disease has not been systematically characterized.
The present study was designed as a prospective observational cohort to investigate the clinicopathologic evolution of permanent synthetic filler disease. The central exposure variable is the interval between filler injection and surgical tissue sampling, expressed in years. Clinical manifestations, magnetic resonance imaging findings, and histopathologic characteristics will be integrated to determine whether reproducible disease states are associated with increasing time since injection.
Histopathologic evaluation will assess predefined features within the adipose, inflammatory, granulomatous, fibrotic, vascular, and lymphatic compartments. Adipose tissue findings will include adipocyte size heterogeneity, vacuolization, fragmentation, fat necrosis, lipophagic reaction, and disruption of lobular architecture. Inflammatory findings will include acute inflammatory activity, chronic histiocytic and lymphoplasmacytic inflammation, multinucleated foreign-body giant cells, and granuloma formation. Fibrotic findings will include the extent and pattern of fibrosis, capsular organization, hyalinization, and structural disruption or fragmentation. The distribution and morphology of exogenous material, including intracellular, extracellular, vacuolar, and collagen-associated patterns, will also be documented when identifiable.
Magnetic resonance imaging will be used to characterize the presence and anatomical extent of filler migration. Clinical data will include local and systemic manifestations documented prospectively during patient evaluation.
Disease duration will initially be analyzed as a continuous variable. Nonlinear temporal relationships between disease duration and selected clinical, radiologic, and histopathologic outcomes may be assessed using flexible regression methods. The study will also evaluate whether mature or disrupted fibrotic compartments are associated with superimposed acute inflammatory activity, as a potential morphologic correlate of inflammatory reactivation in longstanding disease.
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 when required by the approved research protocol.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutive participants with a documented history of gluteal injection of permanent synthetic fillers who undergo prospective clinical assessment, magnetic resonance imaging, and clinically indicated surgical removal of affected tissue with subsequent histopathologic evaluation. Participants are not assigned to an intervention by the investigators.
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 week
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 year
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 week
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 week
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 week
Plan to share: No — not contempled in the patient consent form
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Granuloma, Foreign-Body