Efficacy and Safety of Poly-L-lactic Acid

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

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

Study Overview

• Status: Completed
• Conditions: Buttock Contouring; Buttock Lifting
• Intervention / Treatment: Device: Poly-L-lactic acid (Sculptra® Aesthetic)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Westmount, Quebec, Canada, H3R 3A1
      • Erevna Innovations Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female;
2. Age between 30 and 60 years;
3. Indication for treatment of bilateral contour deformities;
4. Mild to moderate flaccidity in the area to be treated, according to investigator's assessment;
5. 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.
6. . Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure.

Exclusion Criteria:

1. 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;
2. Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments;
3. Using or planning to initiate restrictive diets (at investigator's discretion);
4. Using or planning to initiate use of supplements for weight loss;
5. Diabetes mellitus type 1 or type 2;
6. Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
7. Using or have used within the previous 3 months drugs such as corticosteroids, immunosuppressants, anticoagulants or other collagen-production inhibitors;
8. Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
9. Practices regularly or intend to practice during the study high-performance or impact physical activities, such as weight lifting, marathon, triathlon;
10. 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);
11. Sculptra® Aesthetic should not be used in any person who has hypersensitivity to any of the components of the product;
12. Active skin inflammation or infection in or near the treatment area;
13. Sculptra® Aesthetic should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring;
14. Sculptra® Aesthetic should not be used in patients with implants in the treated regions;
15. Possessing any of the contraindications for use of Sculptra® Aesthetic.

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin hydration as measured by the corneometer	The Corneometer® CM 825 will be used to measure the skin's hydration, in the center of each four buttock quadrant, at all visits.	All Visits; Baseline to month 6
Corporeal contour as measured by the VisioScan	Evaluation of corporeal contour will be performed at all visits using The Visioscan® VC 98 to identify select, major surface irregularities and/or textural depressions caused by skin sagging (often mistaken for "cellulite").	All Visits; Baseline to month 6
Skin elasticity as measured by the cutometer	Evaluation of corporeal contour and skin parameters, using The Cutometer® Dual Multi-Probe Adapter (MPA) 580 to measure skin's elasticity, at all visits.	All Visits; Baseline to month 6
cellulite severity as evaluated by the Nürnberger-Müller Scale for Cellulite	Evaluations of the blinded reviewer's Nürnberger-Müller Scale for Cellulite between Baseline (Visit 0/1) and Follow up visits (Visits 4 to 6). The Nurnberger-Muller Scale classifies cellulite into four categories: Stage Zero No dimpling is seen on the skin when you are standing naked in front of the mirror. When the skin is pinched no orange peel effect is seen. Stage One No dimpling is seen on the skin when you are standing, but when you pinch your skin you have bumps and lumps. Stage two You can see dimpling or the orange peel appearance when standing naked in front of the mirror, but not when lie down. Stage three You can see dimpling both when you are standing and lying down.	Baseline and month 3; Baseline and month 6
Evaluations of patient satisfaction using the Patient Satisfaction Questionnaire at all visits	The Patient Satisfaction Questionnaire is a 5-point likert scale, including: Very dissatisfied; Dissatisfied; Slightly satisfied; Satisfied; Very satisfied.	All Visits; Baseline to month 6
Evaluations of the investigator assessed GAIS scale at all visits (0-6).	The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "worse," "no change," "improved," "much improved," and "very much improved."	Baseline to Month 6

Collaborators and Investigators

• Sponsor: Erevna Innovations Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): March 8, 2020

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018EI - S01

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