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Completed

NCT Number: NCT01545557

Pan Facial Volume Restoration

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%.

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Key information

Conditions

Volume Loss (Soft Tissue Ptosis or Atrophy ) Atrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Investigational Center, Botucatu, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic acid dermal filler gel

Device

1 Emervel Volume injection per indication and 1 touch-up injection if necessary

Other names: Study filler is Emervel Volume Lidocaine.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler

Acronym: EVE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2012
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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