Buttock ContouringPhase 4NCT03922464
Efficacy and Safety of Poly-L-lactic Acid
A Phase 4 study testing Poly-L-lactic acid (Sculptra® Aesthetic) in people with Buttock Contouring and Buttock Lifting, run by Erevna Innovations Inc. at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Buttock Contouring, Buttock Lifting
- What is being tested?
- Poly-L-lactic acid (Sculptra® Aesthetic)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2019to 8 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Buttock Contouring, Buttock Lifting
- Being tested
- Poly-L-lactic acid (Sculptra® Aesthetic)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-lactic acid (Sculptra® Aesthetic)Device
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 being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects to achieve a one-point increase or higher since Baseline, on the Global Aesthetic Improvement Scale (GAIS) at Visit 6
Measured: Month 6
Secondary outcomes (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.
Measured: All visits, Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start8 Apr 2019
- Primary completion8 Jan 2020
- Study completion8 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buttock ContouringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922464
- Sponsor's protocol ID
- 2018EI - S01
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2019
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03922464
- Acronym / sponsor ID
- 2018EI - S01
- Conditions
- Buttock Contouring, Buttock Lifting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Mar 2020 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Poly-L-lactic acid (Sculptra® Aesthetic) in people with Buttock Contouring and Buttock Lifting, run by Erevna Innovations Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.