Pan Facial Volume Restoration (EVE)

February 27, 2023 updated by: Galderma R&D

Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Botucatu, Brazil
        • Galderma Investigational Center
      • Rio de Janeiro, Brazil
        • Galderma Investigational Center
      • Saö Paulo, Brazil
        • Galderma Investigational Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic acid dermal filler
One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed
Device: Hyaluronic acid dermal filler gel
1 Emervel Volume injection per indication and 1 touch-up injection if necessary
Other Names:
  • Study filler is Emervel Volume Lidocaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Volume Loss Assessment
Time Frame: 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.
Baseline and 18 Months after last injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection
Time Frame: 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.
At 3 Weeks after last injection
Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler
Time Frame: 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.
Baseline up to 18 Months after last injection
Number of Participants With Adverse Events (AEs)
Time Frame: 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.
Baseline up to 18 Months after last injection
Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Study Director: Clinical Scientist, Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2012

Primary Completion (Actual)

March 3, 2014

Study Completion (Actual)

March 3, 2014

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.CIP.29090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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