Volume Restoration and Shaping of the ButtocksPhase 4NCT01331408
A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks
A Phase 4 study testing Macrolane VRF30 in people with Volume Restoration and Shaping of the Buttocks, run by Galderma R&D at 4 sites in 3 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volume Restoration and Shaping of the Buttocks
- What is being tested?
- Macrolane VRF30
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2008to May 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 20 years old
- willing to undergo augmentation therapy of the buttocks where a maximum total injected volume of 400 ml of the study product is judged by the Investigator to be enough to achieve full correction
- understand and comply with the requirements of the study
- be willing to understand and comply with the requirements of the study
- be willing to abstain from esthetic surgery and esthetical augmentation procedures (other than the study treatment) between the umbilicus and the knees.
- be a male or non-pregnant, non breast-feeding female.
- give written informed consent to participate in the study
Who cannot join
- Active skin disease, inflammation or related conditions Tumors or pre-malign tissue disorder near or on the area to be treated
- scar tissue in the area to be treated
- subjects seeking corrections for other body parts then the buttocks anywhere between the umbilicus and the knees
- subjects with human immunodeficiency virus (HIV) associated lipodystrophy
- subjects having undergone liposuction within 6 months prior to inclusion
- BMI <20 or expected instable weight
Show all 16Show fewer
- insufficient tissue cover in the area to be treated
- excessive skin laxity in the area to be treated
- other injectable implant or permanent implant near or in the area to be treated
- previous radiation therapy of tumors near or in the area to be treated
- concomitant anticoagulant therapy, anti-platelet therapy or a history of bleeding disorders.
- a presence or history of connective tissue diseases
- ongoing immunosuppressive therapy
- known allergies or hypersensitivity reactions towards anesthetics
- previous inflammatory or hypersensitivity reactions towards products containing Hyaluronic acid
- any condition which in the opinion of the investigator makes the subject unsuitable for inclusion use of any investigational drugs or devices within 30 days prior to inclusion.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
Centro Clinico Mir-Mir
Barcelona, 08006
Cirugia Plastica
Madrid, 28046
About this study
Official title: An Open, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks
The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.
- Being tested
- Macrolane VRF30
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macrolane VRF30Device
Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
| Study group | Role | What they receive |
|---|---|---|
| Macrolane VRF30 | Experimental | Injection of Macrolane VRF30 in buttocks Receives: Device: Macrolane VRF30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6
To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS).
Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
Measured: 6 Months
Secondary outcomes (2)
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1
To evaluate the perceived improvement at 1 month compared to baseline as judged by the Subject using GEIS.
Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
Measured: 1 Month
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12
To Evaluate the Perceived Improvement at 12 Months Compared to Baseline as Judged by the Subject Using GEIS.
Percentage of subjects with Improved, Much Improved or Very Much Improved on GEIS, Subject's evaluation.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Volume Restoration and Shaping of the ButtocksStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Hedén, M.D., Principal investigator, Akademikliniken, Storängsvägen 10, 115 42 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331408
- Sponsor's protocol ID
- 31GC0609
- Status last verified
- Jun 2019
- First submitted
- 5 Apr 2011
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Camenisch CC, Tengvar M, Heden P. Macrolane for volume restoration and contouring of the buttocks: magnetic resonance imaging study on localization and degradation. Plast Reconstr Surg. 2013 Oct;132(4):522e-529e. doi: 10.1097/PRS.0b013e31829fe47e.
PubMed 24076699De Meyere B, Mir-Mir S, Penas J, Camenisch CC, Heden P. Stabilized hyaluronic acid gel for volume restoration and contouring of the buttocks: 24-month efficacy and safety. Aesthetic Plast Surg. 2014 Apr;38(2):404-12. doi: 10.1007/s00266-013-0251-9. Epub 2014 Jan 24.
PubMed 24464121
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks
- ClinicalTrials.gov ID
- NCT01331408
- Acronym / sponsor ID
- 31GC0609
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macrolane VRF30 | Experimental | Device: Macrolane VRF30Injection of Macrolane VRF30 in buttocks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 20 years old
- willing to undergo augmentation therapy of the buttocks where a maximum total injected volume of 400 ml of the study product is judged by the Investigator to be enough to achieve full correction
- understand and comply with the requirements of the study
- be willing to understand and comply with the requirements of the study
- be willing to abstain from esthetic surgery and esthetical augmentation procedures (other than the study treatment) between the umbilicus and the knees.
Key exclusion criteria (16 listed)
- Active skin disease, inflammation or related conditions Tumors or pre-malign tissue disorder near or on the area to be treated
- scar tissue in the area to be treated
- subjects seeking corrections for other body parts then the buttocks anywhere between the umbilicus and the knees
- subjects with human immunodeficiency virus (HIV) associated lipodystrophy
- subjects having undergone liposuction within 6 months prior to inclusion
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 |
|---|---|---|
| Macrolane VRF30Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject | Device | Macrolane VRF30 |
Primary outcome
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6
Time frame: 6 Months
To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS). Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
2 secondary outcomes
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1
Time frame: 1 Month
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24076699Camenisch CC, Tengvar M, Heden P. Macrolane for volume restoration and contouring of the buttocks: magnetic resonance imaging study on localization and degradation. Plast Reconstr Surg. 2013 Oct;132(4):522e-529e. doi: 10.1097/PRS.0b013e31829fe47e.
- Results publication: PubMed 24464121De Meyere B, Mir-Mir S, Penas J, Camenisch CC, Heden P. Stabilized hyaluronic acid gel for volume restoration and contouring of the buttocks: 24-month efficacy and safety. Aesthetic Plast Surg. 2014 Apr;38(2):404-12. doi: 10.1007/s00266-013-0251-9. Epub 2014 Jan 24.
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.
Per Hedén, M.D. principal investigator
Akademikliniken, Storängsvägen 10, 115 42 Stockholm, Sweden
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Macrolane VRF30 in people with Volume Restoration and Shaping of the Buttocks, run by Galderma R&D at 4 sites in 3 countries.
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 7 inclusion and 16 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Belgium, Sweden. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6 (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331408, which also lists 2 linked publications.
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 28 Sep 2022.