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NCT Number: NCT06544304

Buttock Augmentation With Polymethylmethacrylate

Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate.

The objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation.

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Key information

Conditions

Aesthetics Augmentation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The sample will be 133 patients. Specific patients will be screened at study sites according to eligibility classifications. After signing the consent form, patients will be included in the study and will be monitored for 9 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 60 years old;
  • Signed Informed Consent Form (ICF);
  • Participant understands and is willing to participate in the clinical study and attend visits.

Exclusion criteria

  • Known history of allergy to formula components;
  • Have the following morbidities (or any other disease that may interfere with the study): chronic inflammatory disease, immunosuppression, diabetes, hypertension, autoimmune disease, dermatological disease in the region to be treated, acute or chronic renal failure, history of coronary disease, history of cerebrovascular disease, current neoplasia, mental illness undergoing psychiatric treatment, obesity with a BMI above 30, asthma, bronchitis, seizures, hepatitis or other active infectious diseases;
  • Pregnancy;
  • Prior filling of glutes;
  • Use of acetylsalicylic acid, anti-inflammatories, anticoagulants, in the fifteen days before the procedure.
  • Vitamin D supplementation, with normal serum levels and which you do not agree to suspend;
  • Use of anabolic hormones;
  • Vitamin D (25 hydroxyvitamin D) greater than 70 ng/mL;
  • Serum calcium greater than 10 mg/dL;
  • Patients with total body PMMA volume of 650mL or more.

Treatment and study plan

PMMA

Device

PMMA 30%

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by clinical evaluation

    Time frame: Before application of PMMA and 6 and 9 months after the procedure

    Occurrence of adverse events in patients who underwent gluteal augmentation with 30% Biosymmetric PMMA. Expected events will be classified as adverse events when they persist for more than two weeks, and should be reported throughout the study. Adverse events not previously identified will also be monitored at all visits.

Secondary outcomes

  1. Changes in normal values of laboratory biochemical tests

    Time frame: Before application of PMMA and 6 and 9 months after the procedure

    laboratory biochemical exams

  2. Volumetric capacity of filled muscle assessed by ultrasound imaging

    Time frame: Before application of PMMA and 6 and 9 months after the procedure

    Using an ultrasound device, images of the gluteus will be obtained to analyze the thickness of the muscle, and thus estimate its volumetric capacity.

  3. Physician satisfaction assessed by GAIS scale

    Time frame: Before application of PMMA and 4, 6 and 9 months after the procedure

    Physician satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters:

    Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient.

    Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition.

  4. Patient satisfaction assessed by GAIS scale

    Time frame: Up to 4, 6 and 9 months after the procedure

    Patient satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters:

    Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient.

    Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos P Cunha

CONTACT

[email protected]

+55 981120522

Sponsors and collaborators

Lead sponsor

MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA

Other

Registry information

Official study title

Interventional, Multicenter, Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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