Safety and Efficacy of Linnea Safe PMMA 30% Use for Gluteal Augmentation. (LinneaSafe30)

February 27, 2025 updated by: LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA.
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women;
  • Older than 18 years;
  • Signed Informed Consent Form;

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PMMA
Gluteal Augmentation with Linnea Safe (PMMA).
Device: PMMA
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: From enrollment to the end of treatment at 12 months

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.
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA.

Investigators

  • Principal Investigator: Fernanda Bortolozo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LEBON_01_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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