Complications of Injectable Permanent Synthetic FillersNCT07867353
Natural History of Injectable Permanent Synthetic Filler Disease
An observational study of Complications of Injectable Permanent Synthetic Fillers, run by Research Inc at 1 site in Colombia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Complications of Injectable Permanent Synthetic Fillers
- Type of treatment
- Injection or infusion
- How many people
- 450 participants
- Where
- 1 siteColombia
- Study dates
- 22 Jan 2020to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Clinica Bioforma
Medellín, Antioquia
Edison Osorio, MD, Plastic surgeon, +573226140611, info@edisonosorio.com
About this study
Official title: Prospective Clinical, Magnetic Resonance Imaging, and Histopathologic Characterization of the Natural History of Injectable Permanent Synthetic Filler Disease
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.
Read the detailed description
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.
- Keywords
- Injectable permanent synthetic fillers, Biopolymers, Foreign-body granuloma, Chronic inflammation, Iatrogenic allogenosis
- Medical subject headings
- Granuloma, Foreign-Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Injectable Permanent Synthetic Filler Disease Cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At surgical tissue sampling; disease duration measured from filler injection to surgical tissue collection. 1 week
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At surgical tissue sampling; 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start22 Jan 2020
- Primary completion2 Oct 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complications of Injectable Permanent Synthetic FillersStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Brian Ramirez, MD, MSc, Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867353
- Sponsor's protocol ID
- 026
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not contempled in the patient consent form
Publications
Pachon Suarez JE, Salazar MC, Rizo VZ. Classification for Staging and Managing Patients with Biopolymer-induced Human Adjuvant Disease. Plast Reconstr Surg Glob Open. 2022 Feb 24;10(2):e4137. doi: 10.1097/GOX.0000000000004137. eCollection 2022 Feb.
PubMed 35233337Novo RC, Salgado CJ, Yim E, Sinha V, Chim HW, Romanelli P. A staging system for gluteal foreign body reaction to injectables. J Plast Reconstr Aesthet Surg. 2016 Aug;69(8):e174-9. doi: 10.1016/j.bjps.2016.05.007. Epub 2016 Jun 2.
PubMed 27325516Kushida-Contreras BH, Gomez-Calva B, Gaxiola-Garcia MA. Cosmetic Injection of Illicit Foreign Materials: Imaging Features and Patterns of Migration in 413 Cases. Aesthet Surg J. 2024 Jan 16;44(2):183-191. doi: 10.1093/asj/sjad336.
PubMed 37863473Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.
PubMed 42495057
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical, Magnetic Resonance Imaging, and Histopathologic Characterization of the Natural History of Injectable Permanent Synthetic Filler Disease
- ClinicalTrials.gov ID
- NCT07867353
- Acronym / sponsor ID
- 026
- Keywords
- Injectable permanent synthetic fillers, Biopolymers, Foreign-body granuloma, Chronic inflammation, Iatrogenic allogenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 2 Oct 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injectable Permanent Synthetic Filler Disease Cohort | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Temporal Pattern of Histopathologic Tissue Injury
Time frame: At surgical tissue sampling; disease duration measured from filler injection to surgical tissue collection. 1 week
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.
4 secondary outcomes
Clinical Symptom Burden According to Disease Duration
Time frame: 1 year
Foreign-Body Granulomatous Inflammation
Time frame: At surgical tissue sampling. 1 week
Severity and Pattern of Fibrosis
Time frame: At surgical tissue sampling. 1 week
Histopathologic Evidence of Superimposed Inflammatory Reactivation
Time frame: At surgical tissue sampling; 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 35233337Pachon Suarez JE, Salazar MC, Rizo VZ. Classification for Staging and Managing Patients with Biopolymer-induced Human Adjuvant Disease. Plast Reconstr Surg Glob Open. 2022 Feb 24;10(2):e4137. doi: 10.1097/GOX.0000000000004137. eCollection 2022 Feb.
- Background: PubMed 27325516Novo RC, Salgado CJ, Yim E, Sinha V, Chim HW, Romanelli P. A staging system for gluteal foreign body reaction to injectables. J Plast Reconstr Aesthet Surg. 2016 Aug;69(8):e174-9. doi: 10.1016/j.bjps.2016.05.007. Epub 2016 Jun 2.
- Background: PubMed 37863473Kushida-Contreras BH, Gomez-Calva B, Gaxiola-Garcia MA. Cosmetic Injection of Illicit Foreign Materials: Imaging Features and Patterns of Migration in 413 Cases. Aesthet Surg J. 2024 Jan 16;44(2):183-191. doi: 10.1093/asj/sjad336.
- Background: PubMed 42495057Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.
- Individual participant dataSharing planned: No. not contempled in the patient consent form
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications of Injectable Permanent Synthetic Fillers, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edison Osorio, MD, Plastic surgeon (+573226140611, info@edisonosorio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal Pattern of Histopathologic Tissue Injury (time frame: At surgical tissue sampling; disease duration measured from filler injection to surgical tissue collection. 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07867353, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.