Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers

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

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-02-28

Brief Summary

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The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

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Detailed Description

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The range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: Emervel Touch, Emervel Classic, Emervel Deep, Emervel Volume and Emervel Lips.

The study will last 6 month.

Injections will be performed at baseline. If necessary, the investigator will perform touch-up injections at the following visit (3 weeks later).

Investigator and subject satisfaction will be collected through questionnaires.

Conditions

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Facial Wrinkles

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

Group Type EXPERIMENTAL

hyaluronic acid dermal fillers

Intervention Type DEVICE

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

Interventions

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hyaluronic acid dermal fillers

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

Intervention Type DEVICE

Other Intervention Names

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Facial wrinkles

Eligibility Criteria

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Inclusion Criteria

* Seeking tissue augmentation treatment on the face,
* Presenting a score of 3 (Moderately deep wrinkle)or 4 (Deep wrinkle) on the Lemperle Rating Scale (LRS) of both nasolabial folds.

Exclusion Criteria

* At risk in term of precautions, warnings and contra-indication referred in the package insert of the study devices,
* Who underwent previous injection of permanent filler in the injected area.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No