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

NCT06851494 | Not Yet Recruiting DMC

• 1 other identifier: LEBON_01_2025
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Gluteal Augmentation

Keywords

buttock augmentation

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (1)

• Patient Satisfaction

  From enrollment to the end of treatment at 12 months

Study Arms (1)

PMMA

EXPERIMENTAL

Gluteal Augmentation with Linnea Safe (PMMA).

Device: PMMA

Interventions

PMMA DEVICE

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.

PMMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA.: lead

Related Publications (13)

• 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.

  PMID: 14648064 BACKGROUND

• Chacur 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.

  PMID: 31333932 BACKGROUND

• Serra 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.

  PMID: 24855130 BACKGROUND

• Atiyeh 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.

  PMID: 35999464 BACKGROUND

• Dai 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.

  PMID: 36284000 BACKGROUND

• de 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.

  PMID: 22437333 BACKGROUND

• Ridwan-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.

  PMID: 30676441 BACKGROUND

• Carvalho 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.

  PMID: 19438669 BACKGROUND

• de 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.

  PMID: 35114708 BACKGROUND

• Clark 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.

  PMID: 2681290 BACKGROUND

• Jordan 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.

  PMID: 12870861 BACKGROUND

• Haneke E. Polymethyl methacrylate microspheres in collagen. Semin Cutan Med Surg. 2004 Dec;23(4):227-32. doi: 10.1016/j.sder.2004.08.002.

  PMID: 15745230 BACKGROUND

• Blanco 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.

  PMID: 29872906 BACKGROUND

Study Officials

• Fernanda Bortolozo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lebon Farma

CONTACT

+55 (51) 3250-8256; juliano.alves@lebonfarma.com.br

Vanessa Ribas

CONTACT

vanessa.ribas@lebonfarma.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share