A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions

NCT ID: NCT02980783

Last Updated: 2019-02-15

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

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-13

Study Completion Date

2016-12-14

Brief Summary

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This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.

Detailed Description

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Conditions

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Cheek Line Depressions

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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Juvéderm® VOLIFT®™ with Lidocaine

Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.

Group Type EXPERIMENTAL

Juvéderm® VOLIFT®™ with Lidocaine

Intervention Type DEVICE

Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.

Interventions

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Juvéderm® VOLIFT®™ with Lidocaine

Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Presence of dynamic radial cheek lines
* Agrees not to make any changes to skin care routines, or to have any facial procedures or treatments during the study

Exclusion Criteria

* Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures during the study
* Undergone temporary facial dermal filler injections with any substance in the face in the 12 months prior to study entry
* Received botulinum toxin therapy of any serotype in any facial area within the previous 6 months agrees not to receive it during the study
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Graeme Kerson

Role: STUDY_DIRECTOR

Allergan

Locations

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Laboratoire DERMSCAN

Lyon, , France

Site Status

Countries

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France

Related Links

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Other Identifiers

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GMA-EAME-FAS-0397

Identifier Type: -

Identifier Source: org_study_id

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