Breast EnhancementPhase 4COBRANCT01299532
Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast
A Phase 4 study testing Macrolane VRF30 in people with Breast Enhancement, run by Galderma R&D at 5 sites in 2 countries.
Trial summary
This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Enhancement
- 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
- 71 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2008to Oct 2013
- 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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 25 and 60 years with small breasts seeking enhancement of the shape and fullness of the breast
Who cannot join
- Unreasonable expectations as regards the increase in breast volume
- Any medical conditions that may interfere in any way.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Sweden3 sites
Plastikkirurggruppen
Stockholm, 113 24
Akademikliniken
Stockholm, 115 42
Proforma Clinic
Stockholm, 118 63
About this study
Official title: An Open, Multi-center Study Evaluating Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast
This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.
- Conditions
- Breast Enhancement
- 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
Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects.
| Study group | Role | What they receive |
|---|---|---|
| Macrolane VRF30 | Experimental | Not described Receives: Device: Macrolane VRF30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS.
Measured: 6 months
Secondary outcomes (17)
To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.
Measured: 24 months
To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary.
Measured: 2 weeks
to study the implant duration and localization as documented by MRI.
Measured: 24 months
to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS.
Measured: 24 months
to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire.
Measured: 24 months
to evaluate pain experience during injection under local anesthesia.
Measured: during injection
To evaluate any difficulties with the interpretation of the mammography image(s)or ultrasonography due to the presence of the implant 24 months after the initial treatment
Measured: 24 months
Re-treatment phase: To evaluate the safety documented by physical examination and by adverse events reported up to 24 months after re-treatment and by mammography and ultrasonography examinations 15 and 39 months after re-treatment.
Measured: 39 months
Re-treatment phase: To evaluate any difficulties with the interpretation of the mammography image(s) or ultrasonography due to the presence of the implant 24 and 48 months after the initial treatment (15 and 39 months after the re-treatment).
Measured: 48 months
Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.
Measured: 2 weeks
Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment.
Measured: 24 months
Re-treatment phase: To evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS up to 24 months after re-treatment.
Measured: 24 months
Re-treatment phase: To evaluate, up to 24 months after re-treatment, the subjects satisfaction with her breast and general appearance using a subject questionnaire.
Measured: 24 months
Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia.
Measured: During re-injection
Re-treatment phase: To evaluate if there are differences in esthetic improvement, subject satisfaction and implant duration, after re-treatment compared to after initial treatment. The visits up to 9 months will be compared.
Measured: 9 months
Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 24 months after last treatment between subjects that have received only one treatment and subjects that have received re-treatment.
Measured: 24 months
Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 12 and 24 months after initial treatment between subjects that have received only one treatment and subjects that have received re-treatment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startNov 2008
- Primary completionJun 2010
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Hedén, M.D., Ph.D., Principal investigator, Akademikliniken, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299532
- Sponsor's protocol ID
- 31GB0801
- Acronym
- COBRA
- Status last verified
- Feb 2011
- First submitted
- 16 Feb 2011
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
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 Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast
- ClinicalTrials.gov ID
- NCT01299532
- Acronym / sponsor ID
- COBRA / 31GB0801
- Conditions
- Breast Enhancement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Feb 2011 (estimated)
- 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 an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macrolane VRF30 | Experimental | Device: Macrolane VRF30 |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between 25 and 60 years with small breasts seeking enhancement of the shape and fullness of the breast
Key exclusion criteria (2 listed)
- Unreasonable expectations as regards the increase in breast volume
- Any medical conditions that may interfere in any way.
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 VRF30Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects. | Device | Macrolane VRF30 |
Primary outcome
Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS.
Time frame: 6 months
17 secondary outcomes
To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.
Time frame: 24 months
To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary.
Time frame: 2 weeks
to study the implant duration and localization as documented by MRI.
Time frame: 24 months
to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS.
Time frame: 24 months
to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire.
Time frame: 24 months
to evaluate pain experience during injection under local anesthesia.
Time frame: during injection
To evaluate any difficulties with the interpretation of the mammography image(s)or ultrasonography due to the presence of the implant 24 months after the initial treatment
Time frame: 24 months
Re-treatment phase: To evaluate the safety documented by physical examination and by adverse events reported up to 24 months after re-treatment and by mammography and ultrasonography examinations 15 and 39 months after re-treatment.
Time frame: 39 months
Re-treatment phase: To evaluate any difficulties with the interpretation of the mammography image(s) or ultrasonography due to the presence of the implant 24 and 48 months after the initial treatment (15 and 39 months after the re-treatment).
Time frame: 48 months
Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.
Time frame: 2 weeks
Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment.
Time frame: 24 months
Re-treatment phase: To evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS up to 24 months after re-treatment.
Time frame: 24 months
Re-treatment phase: To evaluate, up to 24 months after re-treatment, the subjects satisfaction with her breast and general appearance using a subject questionnaire.
Time frame: 24 months
Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia.
Time frame: During re-injection
Re-treatment phase: To evaluate if there are differences in esthetic improvement, subject satisfaction and implant duration, after re-treatment compared to after initial treatment. The visits up to 9 months will be compared.
Time frame: 9 months
Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 24 months after last treatment between subjects that have received only one treatment and subjects that have received re-treatment.
Time frame: 24 months
Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 12 and 24 months after initial treatment between subjects that have received only one treatment and subjects that have received re-treatment.
Time frame: 24 months
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 28 Sep 2022.
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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 Hedén, M.D., Ph.D. principal investigator
Akademikliniken, Stockholm, Sweden
5 sites in 2 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 Breast Enhancement, run by Galderma R&D at 5 sites in 2 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 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.
Where is the study taking place?
The record lists 5 sites in Sweden, France. 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?
Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS. (time frame: 6 months). 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 28 Sep 2022.