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

Launched by LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA. · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LinneaSafe 30% PMMA, which is used to enhance the shape and size of the buttocks, a procedure known as gluteal augmentation. The researchers want to find out how safe this treatment is and how satisfied patients are after receiving it. The trial will involve 119 participants who are men and women over 18 years old and are interested in this procedure. They will need to sign a form agreeing to participate and meet certain health requirements to be eligible.

Before joining the trial, potential participants will be assessed to ensure they do not have certain health conditions that could complicate the treatment. For example, individuals who have previously had certain types of injections in their glutes or have specific health issues, such as uncontrolled diabetes or autoimmune diseases, will not be able to participate. Those who join the study can expect to receive the treatment and will be monitored for any side effects while also being asked about their satisfaction with the results. This study is not yet recruiting participants, but it aims to provide important information about this new augmentation method.

Gender

ALL

Eligibility criteria

• 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.