Efficacy and Safety of Poly-L-lactic Acid

Study Overview
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Brief Summary
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This is a phase IV prospective, multicentre, single cohort, open-label clinical trial evaluating the efficacy and safety of Poly-L-lactic acid (Sculptra® Aesthetic) for the treatment of contour deformities of the buttocks region

Official Title
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A Prospective, Multicenter Trial on the Efficacy and Safety of Poly-L-lactic Acid (Sculptra® Aesthetic) for the Treatment of Contour Deformities of the Buttocks Region

Conditions
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Buttock Contouring, Buttock Lifting

Intervention / Treatment
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* Device: Poly-L-lactic acid (Sculptra® Aesthetic)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female; Age between 30 and 60 years; Indication for treatment of bilateral contour deformities; Mild to moderate flaccidity in the area to be treated, according to investigator's assessment; An intact immune system, as the bio-stimulatory effect of Sculptra® Aesthetic is dependent on the host response. An intact immune system, as the bio-stimulatory effect of Sculptra® Aesthetic is dependent on the host response. Immune function will be evaluated through clinical history. Exclusions will consist of both primary (genetic) and secondary (acquired) immune deficiencies. Examples include: HIV/AIDS, chemotherapy, cancers (e.g., leukemia and lymphoma), certain autoimmune diseases (e.g., myasthenia gravis, systemic lupus erythematosus), certain medications (e.g., corticosteroids, tumor necrosis factor inhibitors, anticonvulsants), and certain chronic or congenital diseases. Any type of comorbidity or clinical condition will be reviewed at the investigator's discretion. . Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure. Exclusion Criteria: Prior (i.e., <1 year) or planned use (for the duration of the study period) any other aesthetic treatment in the buttock region, such as radiofrequency, cryolipolysis, dermal subscision, plastic surgery, laser treatment, chemical peeling or any other procedure based on active dermal response; Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments; Using or planning to initiate restrictive diets (at investigator's discretion); Using or planning to initiate use of supplements for weight loss; Diabetes mellitus type 1 or type 2; Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments; Using or have used within the previous 3 months drugs such as corticosteroids, immunosuppressants, anticoagulants or other collagen-production inhibitors; Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; Practices regularly or intend to practice during the study high-performance or impact physical activities, such as weight lifting, marathon, triathlon; Pregnant or breastfeeding, or wishes to get pregnant within the next 18 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential); Sculptra® Aesthetic should not be used in any person who has hypersensitivity to any of the components of the product; Active skin inflammation or infection in or near the treatment area; Sculptra® Aesthetic should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring; Sculptra® Aesthetic should not be used in patients with implants in the treated regions; Possessing any of the contraindications for use of Sculptra® Aesthetic.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Poly-L-lactic acid (Sculptra® Aesthetic)|Sculptra® Aesthetic is a commercially available product that is licensed for sale in Canada. It is an injectable implant that contains microparticles of poly-L-lactic acid (PLLA), a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra® Aesthetic is suitable for increasing the volume of depressed areas, particularly to correct skin depressions, such as in skin creases, wrinkles, folds, scars and for skin aging. Sculptra® Aesthetic is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy). The safety and efficacy of Sculptra® Aesthetic has been investigated in the literature and is generally considered safe and effective. PLLA has been used successfully to reverse HIV-associated lipoatrophy as well as to rejuvenate the face, neck, décolletage, hands, abdomen and gluteal regions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects to achieve a one-point increase or higher since Baseline, on the Global Aesthetic Improvement Scale (GAIS) at Visit 6 |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events (AEs) at all study visits (Visits 0-6). The incidence, seriousness, severity and relationship with the medical device of AEs reported will be evaluated. |  | All visits, Baseline to Month 6 |