Volume Loss (Soft Tissue Ptosis or Atrophy )
Conditions
Keywords
Volume loss
Brief summary
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.
Detailed description
Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators. This device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly). Study duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).
Interventions
DEVICEHyaluronic acid dermal filler gel
1 Emervel Volume injection per indication and 1 touch-up injection if necessary
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects seeking treatment for correction of volume loss. * Subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected.
Exclusion criteria
* Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device, * Subjects who underwent previous injection of permanent filler in the injected area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Volume Loss Assessment | Baseline and 18 Months after last injection | Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection | At 3 Weeks after last injection | Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question ; Rate overall, full face aesthetic outcome using the following options: not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full face aesthetic outcome at 3 weeks after last injection were reported. |
| Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler | Baseline up to 18 Months after last injection | The study investigators (injectors) were requested to complete a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler (Emervel® Volume Lidocaine). The percentage of investigators who agreed to use Emervel® Volume Lidocaine again were reported in this outcome measure. |
| Number of Participants With Adverse Events (AEs) | Baseline up to 18 Months after last injection | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection | At 18 Months after last injection | Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question; rate overall, full face aesthetic outcome using the following options : not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full-face aesthetic outcome at 18 Months after last injection were reported. |
Countries
Brazil
Participant flow
Recruitment details
Sixty subjects were recruited across 4 sites in Brazil (15 subjects per site) between February 2012 and October 2013.
Participants by arm
| Arm | Count |
|---|---|
| Hyaluronic Acid Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Hyaluronic Acid |
|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 8.3 |
| Race/Ethnicity, Customized Race Black or African American | 6 Participants |
| Race/Ethnicity, Customized Race Hispanic | 1 Participants |
| Race/Ethnicity, Customized Race White | 53 Participants |
| Region of Enrollment Brazil | 60 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 2 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Mean Change From Baseline in Volume Loss Assessment
Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.
Time frame: Baseline and 18 Months after last injection
Population: ITT population included all participants who were injected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Volume loss18 Months After Injection | Mean Change From Baseline in Volume Loss Assessment | -0.8 Score on a scale | Standard Deviation 0.7 |
Secondary
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to 18 Months after last injection
Population: The safety population was defined as all participants who were injected with the study product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Volume loss18 Months After Injection | Number of Participants With Adverse Events (AEs) | 9 Participants |
Secondary
Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler
The study investigators (injectors) were requested to complete a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler (Emervel® Volume Lidocaine). The percentage of investigators who agreed to use Emervel® Volume Lidocaine again were reported in this outcome measure.
Time frame: Baseline up to 18 Months after last injection
Population: Here overall number of participants analyzed refers to the study investigators who completed a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Volume loss18 Months After Injection | Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler | 100 percentage of participants |
Secondary
Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection
Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question; rate overall, full face aesthetic outcome using the following options : not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full-face aesthetic outcome at 18 Months after last injection were reported.
Time frame: At 18 Months after last injection
Population: All injected subjects satisfied to very satisfied
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Volume loss18 Months After Injection | Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection | Satisfied | 25 percentage of participants |
| Volume loss18 Months After Injection | Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection | Very satisfied | 70 percentage of participants |
Secondary
Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection
Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question ; Rate overall, full face aesthetic outcome using the following options: not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full face aesthetic outcome at 3 weeks after last injection were reported.
Time frame: At 3 Weeks after last injection
Population: ITT population included all participants who were injected. Here, 'overall number of participants analyzed' signifies participants who completed a questionnaire about their satisfaction with the overall, full face aesthetic outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Volume loss18 Months After Injection | Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection | Satisfied | 32.2 Percentage of participants |
| Volume loss18 Months After Injection | Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection | Very satisfied | 67.8 Percentage of participants |