Back to resultsPan Facial Volume Restoration (EVE)
Primary Purpose
Volume Loss (Soft Tissue Ptosis or Atrophy )
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hyaluronic acid dermal filler gel
Sponsored by
About this trial
This is an interventional treatment trial for Volume Loss (Soft Tissue Ptosis or Atrophy ) focused on measuring Volume loss
Eligibility Criteria
Inclusion Criteria:
- Subjects seeking treatment for correction of volume loss.
- Subjects presenting a score of 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.
Sites / Locations
- Galderma Investigational Center
- Galderma Investigational Center
- Galderma Investigational Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyaluronic acid dermal filler
Arm Description
One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01545557
Brief Title
Pan Facial Volume Restoration
Acronym
EVE
Official Title
Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2012 (Actual)
Primary Completion Date
March 3, 2014 (Actual)
Study Completion Date
March 3, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Volume Loss (Soft Tissue Ptosis or Atrophy )
Keywords
Volume loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic acid dermal filler
Arm Type
Experimental
Arm Description
One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid dermal filler gel
Other Intervention Name(s)
Study filler is Emervel Volume Lidocaine.
Intervention Description
1 Emervel Volume injection per indication and 1 touch-up injection if necessary
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Volume Loss Assessment
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection
Description
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
Title
Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler
Description
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
Title
Number of Participants With Adverse Events (AEs)
Description
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
Title
Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Scientist
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Galderma Investigational Center
City
Botucatu
Country
Brazil
Facility Name
Galderma Investigational Center
City
Rio de Janeiro
Country
Brazil
Facility Name
Galderma Investigational Center
City
Saö Paulo
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pan Facial Volume Restoration
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