Condition or disease | Intervention/treatment | Phase |
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Buttock Contouring Buttock Lifting | Device: Poly-L-lactic acid (Sculptra® Aesthetic) | Phase 4 |
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 |
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.
The Patient Satisfaction Questionnaire is a 5-point likert scale, including:
Very dissatisfied; Dissatisfied; Slightly satisfied; Satisfied; Very satisfied.
Tracking Information | |||||||
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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 |
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 |
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 |
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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 |
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Condition ICMJE |
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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. |
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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. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |