Breast EnhancementNCT01308853
Macrolane for Enhancement of the Shape and Fullness of the Female Breast
A study testing Macrolane in people with Breast Enhancement, run by Galderma R&D.
Trial summary
The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Enhancement
- What is being tested?
- Macrolane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to May 2010
- Phase
- Interventional
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast
Who cannot join
- Unreasonable expectations
- Any medical condition that may interfere with the treatment
About this study
Official title: An Open, Multi-center Study Evaluating Treatment Procedure, Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast
The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.
Read the detailed description
This study evaluates the injection technique and treatment outcome by stepwise inclusion and treatment of Macrolane for female breast enhancement.
- Conditions
- Breast Enhancement
- Being tested
- Macrolane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacrolaneDevice
Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.
| Study group | Role | What they receive |
|---|---|---|
| Macrolane | Other | Open label Receives: Device: Macrolane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment
Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters.
Measured: 6 weeks
Secondary outcomes (1)
Percentage of Breasts With Improvement as Assessed by the Investigator
Esthetic improvement was evaluated using the Global Esthetic Improvement Scale (GEIS).
The scale has five grades ranging from worse to very much improved. Subjects defined as "at least improved" are assessed as improved, much improved or very much improved.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionMay 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for Breast EnhancementStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Heden, M.D., Principal investigator, Akademikliniken, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308853
- Sponsor's protocol ID
- 31GB0607
- Status last verified
- Jun 2019
- First submitted
- 22 Feb 2011
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Heden P, Olenius M, Tengvar M. Macrolane for breast enhancement: 12-month follow-up. Plast Reconstr Surg. 2011 Feb;127(2):850-860. doi: 10.1097/PRS.0b013e318200ae57.
PubMed 20966812
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, Multi-center Study Evaluating Treatment Procedure, Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast
- ClinicalTrials.gov ID
- NCT01308853
- Acronym / sponsor ID
- 31GB0607
- Conditions
- Breast Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.
Detailed description
This study evaluates the injection technique and treatment outcome by stepwise inclusion and treatment of Macrolane for female breast enhancement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macrolane | Other | Device: MacrolaneOpen label |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast
Key exclusion criteria (2 listed)
- Unreasonable expectations
- Any medical condition that may interfere with the treatment
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 |
|---|---|---|
| MacrolaneDevice: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast. | Device | Macrolane |
Primary outcome
Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment
Time frame: 6 weeks
Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters.
1 secondary outcome
Percentage of Breasts With Improvement as Assessed by the Investigator
Time frame: 6 weeks
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 20966812Heden P, Olenius M, Tengvar M. Macrolane for breast enhancement: 12-month follow-up. Plast Reconstr Surg. 2011 Feb;127(2):850-860. doi: 10.1097/PRS.0b013e318200ae57.
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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 Heden, M.D. principal investigator
Akademikliniken, Stockholm, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Macrolane in people with Breast Enhancement, run by Galderma R&D.
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 1 inclusion and 2 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.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 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?
Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment (time frame: 6 weeks). 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 NCT01308853, which also lists 1 linked publication.
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.