Breast Enhancement
Conditions
Brief summary
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.
Interventions
DEVICEMacrolane
Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast
Exclusion criteria
* Unreasonable expectations * Any medical condition that may interfere with the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Breasts With Improvement as Assessed by the Investigator | 6 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Macrolane Open label
Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Insertion of permanent implants | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Macrolane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 37.4 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment Sweden | 24 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: All included participants (Intention To Treat)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane | Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment | 48 Breasts |
Secondary
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.
Time frame: 6 weeks
Population: Intention to treat. Data from 1 participant not available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane | Percentage of Breasts With Improvement as Assessed by the Investigator | 100 percentage of breasts |