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出境医 / 临床实验 / Efficacy and Safety of Poly-L-lactic Acid

Efficacy and Safety of Poly-L-lactic Acid

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Buttock Contouring Buttock Lifting Device: Poly-L-lactic acid (Sculptra® Aesthetic) Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 8, 2019
Actual Primary Completion Date : January 8, 2020
Actual Study Completion Date : March 8, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Percentage of subjects to achieve a one-point increase or higher since Baseline, on the Global Aesthetic Improvement Scale (GAIS) at Visit 6 [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: All visits, Baseline to Month 6 ]

Other Outcome Measures:
  1. Skin hydration as measured by the corneometer [ Time Frame: All Visits; Baseline to month 6 ]
    The Corneometer® CM 825 will be used to measure the skin's hydration, in the center of each four buttock quadrant, at all visits.

  2. Corporeal contour as measured by the VisioScan [ Time Frame: All Visits; Baseline to month 6 ]
    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").

  3. Skin elasticity as measured by the cutometer [ Time Frame: All Visits; Baseline to month 6 ]
    Evaluation of corporeal contour and skin parameters, using The Cutometer® Dual Multi-Probe Adapter (MPA) 580 to measure skin's elasticity, at all visits.

  4. cellulite severity as evaluated by the Nürnberger-Müller Scale for Cellulite [ Time Frame: Baseline and month 3; Baseline and month 6 ]

    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.


  5. Evaluations of patient satisfaction using the Patient Satisfaction Questionnaire at all visits [ Time Frame: All Visits; Baseline to month 6 ]

    The Patient Satisfaction Questionnaire is a 5-point likert scale, including:

    Very dissatisfied; Dissatisfied; Slightly satisfied; Satisfied; Very satisfied.


  6. Evaluations of the investigator assessed GAIS scale at all visits (0-6). [ Time Frame: Baseline to Month 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."


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date April 10, 2020
Actual Study Start Date  ICMJE April 8, 2019
Actual Primary Completion Date January 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
Percentage of subjects to achieve a one-point increase or higher since Baseline, on the Global Aesthetic Improvement Scale (GAIS) at Visit 6 [ Time Frame: Month 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
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. [ Time Frame: All visits, Baseline to Month 6 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2019)
  • Skin hydration as measured by the corneometer [ Time Frame: All Visits; Baseline to month 6 ]
    The Corneometer® CM 825 will be used to measure the skin's hydration, in the center of each four buttock quadrant, at all visits.
  • Corporeal contour as measured by the VisioScan [ Time Frame: All Visits; Baseline to month 6 ]
    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").
  • Skin elasticity as measured by the cutometer [ Time Frame: All Visits; Baseline to month 6 ]
    Evaluation of corporeal contour and skin parameters, using The Cutometer® Dual Multi-Probe Adapter (MPA) 580 to measure skin's elasticity, at all visits.
  • cellulite severity as evaluated by the Nürnberger-Müller Scale for Cellulite [ Time Frame: Baseline and month 3; Baseline and month 6 ]
    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.
  • Evaluations of patient satisfaction using the Patient Satisfaction Questionnaire at all visits [ Time Frame: All Visits; Baseline to month 6 ]
    The Patient Satisfaction Questionnaire is a 5-point likert scale, including: Very dissatisfied; Dissatisfied; Slightly satisfied; Satisfied; Very satisfied.
  • Evaluations of the investigator assessed GAIS scale at all visits (0-6). [ Time Frame: Baseline to Month 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."
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Poly-L-lactic Acid
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Buttock Contouring
  • Buttock Lifting
Intervention  ICMJE 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.

Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 8, 2020
Actual Primary Completion Date January 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female gender.
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922464
Other Study ID Numbers  ICMJE 2018EI - S01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Erevna Innovations Inc.
Study Sponsor  ICMJE Erevna Innovations Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Erevna Innovations Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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