NCT02980783

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

November 30, 2016

Results QC Date

January 8, 2018

Last Update Submit

September 25, 2018

Conditions

Cheek Line Depressions

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)

    Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.

    Baseline (Day 1) to Day 45

Secondary Outcomes (7)

  • Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®

    Baseline (Day 1) to Day 45

  • Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®

    Baseline (Day 1) to Day 45

  • Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®

    Baseline (Day 1) to Day 45

  • Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile

    Baseline (Day 1) to Day 45

  • Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS

    Baseline (Day 1) to Day 45

  • +2 more secondary outcomes

Study Arms (1)

Juvéderm® VOLIFT®™ with Lidocaine

EXPERIMENTAL

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.

Device: Juvéderm® VOLIFT®™ with Lidocaine

Interventions

Juvéderm® VOLIFT®™ with LidocaineDEVICE

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.

Juvéderm® VOLIFT®™ with Lidocaine

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire DERMSCAN

Lyon, 69100, France

Location

Related Links

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Graeme Kerson

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

October 13, 2016

Primary Completion

December 14, 2016

Study Completion

December 14, 2016

Last Updated

February 15, 2019

Results First Posted

February 15, 2019

Record last verified: 2018-09

Locations

FR(1)