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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%.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid dermal filler | Experimental | One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid dermal filler gel | Device | 1 Emervel Volume injection per indication and 1 touch-up injection if necessary |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 18 Months after last injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Scientist | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Center | Botucatu | Brazil | ||||
| Galderma Investigational Center |
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Sixty subjects were recruited across 4 sites in Brazil (15 subjects per site) between February 2012 and October 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyaluronic Acid | Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyaluronic Acid | Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT population included all participants who were injected. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 18 Months after last injection |
|
From Baseline up to 18 Months after last injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyaluronic Acid | Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment | unrelated to study product or injection procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical project manager | Galderma | 817-961-5655 | aestheticclinicaltrials@galderma.com |
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| ID | Term |
|---|---|
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| At 3 Weeks after last injection |
| 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. | Baseline up to 18 Months after last injection |
| 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. | Baseline up to 18 Months after last injection |
| 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. | At 18 Months after last injection |
| Rio de Janeiro |
| Brazil |
| Galderma Investigational Center | Saö Paulo | Brazil |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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. | 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. | Posted | Number | Percentage of participants | At 3 Weeks after last injection |
|
|
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| 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. | 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. | Posted | Number | percentage of participants | Baseline up to 18 Months after last injection |
|
|
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| 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. | The safety population was defined as all participants who were injected with the study product. | Posted | Count of Participants | Participants | Baseline up to 18 Months after last injection |
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|
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| 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. | All injected subjects satisfied to very satisfied | Posted | Number | percentage of participants | At 18 Months after last injection |
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| 0 |
| 60 |
| 0 |
| 60 |
| 2 |
| 60 |
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Any intent of Institution and Investigator/Researcher to publish or disclose in any way Information requires Sponsor's prior written approval. Investigator/Researcher shall provide his draft of such publication to Sponsor for review and approval at least two months prior to the date of intended publication. Sponsor hereby agrees he shall endeavour to preserve accuracy of results in authorized publications and negative as well as positive results shall be published or made publicly available.