Pan Facial Volume Restoration

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-21

Study Completion Date

2014-03-03

Brief Summary

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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%.

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Detailed Description

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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).

Conditions

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Volume Loss (Soft Tissue Ptosis or Atrophy )

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyaluronic acid dermal filler

One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed

Group Type EXPERIMENTAL

Hyaluronic acid dermal filler gel

Intervention Type DEVICE

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

Interventions

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Hyaluronic acid dermal filler gel

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

Intervention Type DEVICE

Other Intervention Names

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Study filler is Emervel Volume Lidocaine.

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No