Gluteal AugmentationLinneaSafe30NCT06851494
Safety and Efficacy of Linnea Safe PMMA 30% Use for Gluteal Augmentation.
A study testing PMMA in people with Gluteal Augmentation, run by LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA..
Trial summary
This pre-market, interventional, single-arm study aims to evaluate the safety and efficacy of LinneaSafe 30% polymethylmethacrylate (PMMA) for gluteal augmentation. The study will include 119 patients, with a total recruitment of 137 to account for a 15% drop-out rate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gluteal Augmentation
- What is being tested?
- PMMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Nov 2026
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women;
- Older than 18 years;
- Signed Informed Consent Form;
Who cannot join
- Prior intramuscular filling with PMMA for volumization of the buttocks or other body areas (reported by the patient or verified on ultrasound).
- Clinical history or evidence on ultrasound of intramuscular injection of liquid/industrial silicone, hydrogels (except hyaluronic acid and absorbable biostimulators performed up to 6 months before), synthol, potenay, ADE vitamins or other products in the glutes
- Pregnant or breastfeeding women
- Presence of silicone prosthesis for gluteal augmentation;
- Levels of 25 hydroxy vitamin D > 60 mg/mL;
- Vitamin D supplementation in the 3 months prior to the procedure - even with 25 hydroxy vitamin D levels between 15 and 60 mg/mL
Show all 26Show fewer
- Altered PTH (less than 12pg/mL or greater than 65 pg/mL CRP greater than 1 mg/dL (or 10 mg/L)
- Erythrocyte sedimentation value 2 times higher than normal;
- Women with testosterone levels greater than 70 ng/dL
- Women with estrogen levels greater than 450 pg/mL
- Urea value greater than 50 mg/dL
- Creatinine value greater than 1.3 mg/dL
- Glomerular filtration rate less than 90 mL/min
- Rheumatoid factor value greater than 79 UI/mL
- Ionic calcium values greater than 5.2 mg/dL (or 1.30 mmol/L)
- Total calcium value greater than 10.5 mg/dL
- Iron value greater than 175 µg/dL
- Ferritin value greater than 336 ng/dL
- Calcitriol greater than 90.1pg/dL
- Uncontrolled diabetes (fasting blood glucose > 100mg/dL)
- Antinuclear factor (ANA) > 1:160;
- Personal history of more than one episode of pain due to kidney stones (except during pregnancy)
- Ratio of urinary calcium and urinary creatinine in an isolated urine sample > 250.
- Patients using medications for cancer treatment
- Patients with lupus, systemic scleroderma, dermatomyositis, granulomatous diseases
- Any other contraindications mentioned in the product's instructions for use, such as: history of evolving autoimmune disease, during treatment with immunosuppressants, or in any disorder or active skin infection. The use is absolutely contraindicated in cases of active herpes lesions. In cases of herpetic history, prophylactic treatment is recommended. Any inflammatory reaction from injections is also a contraindication.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Vanessa Ribas contact
About this study
This pre-market, interventional, single-arm study aims to evaluate the safety and efficacy of LinneaSafe 30% polymethylmethacrylate (PMMA) for gluteal augmentation. The study will include 119 patients, with a total recruitment of 137 to account for a 15% drop-out rate. Eligible participants are men and women over 18 years old who express interest and are deemed suitable for the procedure. The primary safety outcome is the incidence of adverse events, while the primary efficacy outcome is patient satisfaction.
Read the detailed description
This pre-market, interventional, single-arm study aims to evaluate the safety and efficacy of LinneaSafe 30% polymethylmethacrylate (PMMA) for gluteal augmentation. The study will include 119 patients, with a total recruitment of 137 to account for a 15% drop-out rate. Eligible participants are men and women over 18 years old who express interest and are deemed suitable for the procedure. The primary safety outcome is the incidence of adverse events, while the primary efficacy outcome is patient satisfaction.
Patient recruitment will be conducted via social media. After signing the consent form, participants will undergo screening, including laboratory tests, gluteal ultrasound, and bioimpedance. The procedure (T0) involves baseline photos, gluteal measurements, and intramuscular PMMA augmentation (maximum 300 mL), followed by an evaluation of patient and clinician satisfaction. Follow-ups include online assessments at T1 week and T3 months to monitor adverse events. At T6 months, patients will undergo clinical evaluation, laboratory tests, photos, and satisfaction assessments, with the possibility of a retouch (up to 120 mL) if necessary, followed by an additional online check-up after one week. The final evaluation at T12 months will include photos, gluteal measurements, laboratory tests, ultrasound, bioimpedance, and an overall assessment of safety and efficacy.
- Conditions
- Gluteal Augmentation
- Being tested
- PMMA
- Keywords
- buttock augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMMADevice
Safety and efficacy evaluation of PMMA LinneaSafe 30% use for gluteal augmentation. Linnea Safe is a water-based gel containing Polymethylmethacrylate (PMMA) in concentrations of 2%, 10% or 30%. LInnea Safe is indicated for facial and body volumetric correction in cases of lipodystrophy due to the use of antiretrovirals in HIV-positive patients. It is also indicated for facial volumetric correction, and can be used in nasolabial folds, glabellar lines, corners of the mouth, upper lip lines, chin lines/chin lines, in the malar region, in acne scars, on the nose, to increase lips and facial contour.
| Study group | Role | What they receive |
|---|---|---|
| PMMA | Experimental | Gluteal Augmentation with Linnea Safe (PMMA). Receives: Device: PMMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Expected events will be classified as adverse events when they persist for more than two weeks, and must be reported throughout the study. Adverse events not previously identified will also be monitored at all visits.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (1)
Patient Satisfaction
Patient and physician satisfaction will be evaluated using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters:
Very much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in the appearance of the initial condition, but not completely optimal for the patient.
Improved (3): obvious improvement in the appearance of the initial condition. No change (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition. The satisfaction assessment will be conducted at the T6 and T12 visits.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gluteal AugmentationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernanda Bortolozo, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851494
- Sponsor's protocol ID
- LEBON_01_2025
- Acronym
- LinneaSafe30
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemperle G, Morhenn V, Charrier U. Human histology and persistence of various injectable filler substances for soft tissue augmentation. Aesthetic Plast Surg. 2003 Sep-Oct;27(5):354-66; discussion 367. doi: 10.1007/s00266-003-3022-1. Epub 2003 Dec 4.
PubMed 14648064Chacur R, Sampaio Menezes H, Maria Bordin da Silva Chacur N, Dias Alves D, Cadore Mafaldo R, Dias Gomes L, Dos Santos Barreto G. Gluteal Augmentation with Polymethyl Methacrylate: A 10-year Cohort Study. Plast Reconstr Surg Glob Open. 2019 May 31;7(5):e2193. doi: 10.1097/GOX.0000000000002193. eCollection 2019 May.
PubMed 31333932Serra MS, Goncalves LZ, Ramos-e-Silva M. Soft tissue augmentation with PMMA-microspheres for the treatment of HIV-associated buttock lipodystrophy. Int J STD AIDS. 2015 Mar;26(4):279-84. doi: 10.1177/0956462414536878. Epub 2014 May 22.
PubMed 24855130Atiyeh B, Ghieh F, Oneisi A. Safety and Efficiency of Minimally Invasive Buttock Augmentation: A Review. Aesthetic Plast Surg. 2023 Feb;47(1):245-259. doi: 10.1007/s00266-022-03049-5. Epub 2022 Aug 23.
PubMed 35999464Dai Y, Chen Y, Hu Y, Zhang L. Current Knowledge and Future Perspectives of Buttock Augmentation: A Bibliometric Analysis from 1999 to 2021. Aesthetic Plast Surg. 2023 Jun;47(3):1091-1103. doi: 10.1007/s00266-022-03140-x. Epub 2022 Oct 25.
PubMed 36284000de Melo Carpaneda E, Carpaneda CA. Adverse results with PMMA fillers. Aesthetic Plast Surg. 2012 Aug;36(4):955-63. doi: 10.1007/s00266-012-9871-8. Epub 2012 Mar 22.
PubMed 22437333Ridwan-Pramana A, Idema S, Te Slaa S, Verver F, Wolff J, Forouzanfar T, Peerdeman S. Polymethyl Methacrylate in Patient-Specific Implants: Description of a New Three-Dimension Technique. J Craniofac Surg. 2019 Mar/Apr;30(2):408-411. doi: 10.1097/SCS.0000000000005148.
PubMed 30676441Carvalho Costa IM, Salaro CP, Costa MC. Polymethylmethacrylate facial implant: a successful personal experience in Brazil for more than 9 years. Dermatol Surg. 2009 Aug;35(8):1221-7. doi: 10.1111/j.1524-4725.2009.01216.x. Epub 2009 May 12.
PubMed 19438669de la Guardia C, Virno A, Musumeci M, Bernardin A, Silberberg MB. Rheologic and Physicochemical Characteristics of Hyaluronic Acid Fillers: Overview and Relationship to Product Performance. Facial Plast Surg. 2022 Apr;38(2):116-123. doi: 10.1055/s-0041-1741560. Epub 2022 Feb 3.
PubMed 35114708Clark DP, Hanke CW, Swanson NA. Dermal implants: safety of products injected for soft tissue augmentation. J Am Acad Dermatol. 1989 Nov;21(5 Pt 1):992-8. doi: 10.1016/s0190-9622(89)70288-7.
PubMed 2681290Jordan DR. Soft-tissue fillers for wrinkles, folds and volume augmentation. Can J Ophthalmol. 2003 Jun;38(4):285-8. doi: 10.1016/s0008-4182(03)80093-5.
PubMed 12870861Haneke E. Polymethyl methacrylate microspheres in collagen. Semin Cutan Med Surg. 2004 Dec;23(4):227-32. doi: 10.1016/j.sder.2004.08.002.
PubMed 15745230Blanco Souza TA, Colome LM, Bender EA, Lemperle G. Brazilian Consensus Recommendation on the Use of Polymethylmethacrylate Filler in Facial and Corporal Aesthetics. Aesthetic Plast Surg. 2018 Oct;42(5):1244-1251. doi: 10.1007/s00266-018-1167-1. Epub 2018 Jun 5.
PubMed 29872906
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Linnea Safe PMMA 30% Use for Gluteal Augmentation.
- ClinicalTrials.gov ID
- NCT06851494
- Acronym / sponsor ID
- LinneaSafe30 / LEBON_01_2025
- Conditions
- Gluteal Augmentation
- Keywords
- buttock augmentation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 28 Feb 2025 (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.
This pre-market, interventional, single-arm study aims to evaluate the safety and efficacy of LinneaSafe 30% polymethylmethacrylate (PMMA) for gluteal augmentation. The study will include 119 patients, with a total recruitment of 137 to account for a 15% drop-out rate. Eligible participants are men and women over 18 years old who express interest and are deemed suitable for the procedure. The primary safety outcome is the incidence of adverse events, while the primary efficacy outcome is patient satisfaction.
Detailed description
This pre-market, interventional, single-arm study aims to evaluate the safety and efficacy of LinneaSafe 30% polymethylmethacrylate (PMMA) for gluteal augmentation. The study will include 119 patients, with a total recruitment of 137 to account for a 15% drop-out rate. Eligible participants are men and women over 18 years old who express interest and are deemed suitable for the procedure. The primary safety outcome is the incidence of adverse events, while the primary efficacy outcome is patient satisfaction.
Patient recruitment will be conducted via social media. After signing the consent form, participants will undergo screening, including laboratory tests, gluteal ultrasound, and bioimpedance. The procedure (T0) involves baseline photos, gluteal measurements, and intramuscular PMMA augmentation (maximum 300 mL), followed by an evaluation of patient and clinician satisfaction. Follow-ups include online assessments at T1 week and T3 months to monitor adverse events. At T6 months, patients will undergo clinical evaluation, laboratory tests, photos, and satisfaction assessments, with the possibility of a retouch (up to 120 mL) if necessary, followed by an additional online check-up after one week. The final evaluation at T12 months will include photos, gluteal measurements, laboratory tests, ultrasound, bioimpedance, and an overall assessment of safety and efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMMA | Experimental | Device: PMMAGluteal Augmentation with Linnea Safe (PMMA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women;
- Older than 18 years;
- Signed Informed Consent Form;
Key exclusion criteria (26 listed)
- Prior intramuscular filling with PMMA for volumization of the buttocks or other body areas (reported by the patient or verified on ultrasound).
- Clinical history or evidence on ultrasound of intramuscular injection of liquid/industrial silicone, hydrogels (except hyaluronic acid and absorbable biostimulators performed up to 6 months before), synthol, potenay, ADE vitamins or other products in the glutes
- Pregnant or breastfeeding women
- Presence of silicone prosthesis for gluteal augmentation;
- Levels of 25 hydroxy vitamin D > 60 mg/mL;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMMASafety and efficacy evaluation of PMMA LinneaSafe 30% use for gluteal augmentation. Linnea Safe is a water-based gel containing Polymethylmethacrylate (PMMA) in concentrations of 2%, 10% or 30%. LInnea Safe is indicated for facial and body volumetric correction in cases of lipodystrophy due to the use of antiretrovirals in HIV-positive patients. It is also indicated for facial volumetric correction, and can be used in nasolabial folds, glabellar lines, corners of the mouth, upper lip lines, chin lines/chin lines, in the malar region, in acne scars, on the nose, to increase lips and facial contour. | Device | PMMA |
Primary outcome
Adverse Events
Time frame: From enrollment to the end of treatment at 12 months
Expected events will be classified as adverse events when they persist for more than two weeks, and must be reported throughout the study. Adverse events not previously identified will also be monitored at all visits.
1 secondary outcome
Patient Satisfaction
Time frame: From enrollment to the end of treatment at 12 months
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 4 Mar 2025.
- Background: PubMed 14648064Lemperle G, Morhenn V, Charrier U. Human histology and persistence of various injectable filler substances for soft tissue augmentation. Aesthetic Plast Surg. 2003 Sep-Oct;27(5):354-66; discussion 367. doi: 10.1007/s00266-003-3022-1. Epub 2003 Dec 4.
- Background: PubMed 31333932Chacur R, Sampaio Menezes H, Maria Bordin da Silva Chacur N, Dias Alves D, Cadore Mafaldo R, Dias Gomes L, Dos Santos Barreto G. Gluteal Augmentation with Polymethyl Methacrylate: A 10-year Cohort Study. Plast Reconstr Surg Glob Open. 2019 May 31;7(5):e2193. doi: 10.1097/GOX.0000000000002193. eCollection 2019 May.
- Background: PubMed 24855130Serra MS, Goncalves LZ, Ramos-e-Silva M. Soft tissue augmentation with PMMA-microspheres for the treatment of HIV-associated buttock lipodystrophy. Int J STD AIDS. 2015 Mar;26(4):279-84. doi: 10.1177/0956462414536878. Epub 2014 May 22.
- Background: PubMed 35999464Atiyeh B, Ghieh F, Oneisi A. Safety and Efficiency of Minimally Invasive Buttock Augmentation: A Review. Aesthetic Plast Surg. 2023 Feb;47(1):245-259. doi: 10.1007/s00266-022-03049-5. Epub 2022 Aug 23.
- Background: PubMed 36284000Dai Y, Chen Y, Hu Y, Zhang L. Current Knowledge and Future Perspectives of Buttock Augmentation: A Bibliometric Analysis from 1999 to 2021. Aesthetic Plast Surg. 2023 Jun;47(3):1091-1103. doi: 10.1007/s00266-022-03140-x. Epub 2022 Oct 25.
- Background: PubMed 22437333de Melo Carpaneda E, Carpaneda CA. Adverse results with PMMA fillers. Aesthetic Plast Surg. 2012 Aug;36(4):955-63. doi: 10.1007/s00266-012-9871-8. Epub 2012 Mar 22.
- Background: PubMed 30676441Ridwan-Pramana A, Idema S, Te Slaa S, Verver F, Wolff J, Forouzanfar T, Peerdeman S. Polymethyl Methacrylate in Patient-Specific Implants: Description of a New Three-Dimension Technique. J Craniofac Surg. 2019 Mar/Apr;30(2):408-411. doi: 10.1097/SCS.0000000000005148.
- Background: PubMed 19438669Carvalho Costa IM, Salaro CP, Costa MC. Polymethylmethacrylate facial implant: a successful personal experience in Brazil for more than 9 years. Dermatol Surg. 2009 Aug;35(8):1221-7. doi: 10.1111/j.1524-4725.2009.01216.x. Epub 2009 May 12.
- Background: PubMed 35114708de la Guardia C, Virno A, Musumeci M, Bernardin A, Silberberg MB. Rheologic and Physicochemical Characteristics of Hyaluronic Acid Fillers: Overview and Relationship to Product Performance. Facial Plast Surg. 2022 Apr;38(2):116-123. doi: 10.1055/s-0041-1741560. Epub 2022 Feb 3.
- Background: PubMed 2681290Clark DP, Hanke CW, Swanson NA. Dermal implants: safety of products injected for soft tissue augmentation. J Am Acad Dermatol. 1989 Nov;21(5 Pt 1):992-8. doi: 10.1016/s0190-9622(89)70288-7.
- Background: PubMed 12870861Jordan DR. Soft-tissue fillers for wrinkles, folds and volume augmentation. Can J Ophthalmol. 2003 Jun;38(4):285-8. doi: 10.1016/s0008-4182(03)80093-5.
- Background: PubMed 15745230Haneke E. Polymethyl methacrylate microspheres in collagen. Semin Cutan Med Surg. 2004 Dec;23(4):227-32. doi: 10.1016/j.sder.2004.08.002.
- Individual participant dataSharing planned: No
Related trials for Gluteal Augmentation
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.
Vanessa Ribas contact
Fernanda Bortolozo principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing PMMA in people with Gluteal Augmentation, run by LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA..
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 3 inclusion and 26 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: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Lebon Farma (+55 (51) 3250-8256, juliano.alves@lebonfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From enrollment to the end of treatment at 12 months). 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 NCT06851494, which also lists 13 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 4 Mar 2025.