NCT03438266

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

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

First Submitted

Initial submission to the registry

February 5, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

February 5, 2018

Results QC Date

May 29, 2019

Last Update Submit

August 1, 2019

Conditions

Age-related Volume Deficit in the Mid-face

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score

    The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement.

    Baseline (Screening) to Month 1

Secondary Outcomes (3)

  • Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score

    Baseline (Screening) to Month 1

  • Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score

    Baseline (Screening) to Month 1

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Up to 3 months

Study Arms (2)

JUVÉDERM VOLUMA® XC Injectable Gel with Cannula

EXPERIMENTAL

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.

Device: JUVÉDERM VOLUMA® XC injectable gel with cannula

JUVÉDERM VOLUMA® XC Injectable Gel with Needle

OTHER

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.

Device: JUVÉDERM VOLUMA® XC injectable gel with needle

Interventions

JUVÉDERM VOLUMA® XC injectable gel with cannulaDEVICE

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.

JUVÉDERM VOLUMA® XC Injectable Gel with Cannula
JUVÉDERM VOLUMA® XC injectable gel with needleDEVICE

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.

JUVÉDERM VOLUMA® XC Injectable Gel with Needle

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);

You may not qualify if:

  • Has any facial procedures or trauma that may interfere with the study procedures and results;
  • Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;
  • Has active autoimmune disease;
  • Has current cutaneous or mucosal inflammatory or infectious processes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Skin Care and Laser Physicians of Beverly Hills

Los Angeles, California, 90069, United States

Location

Art of Skin MD

Solana Beach, California, 92075, United States

Location

Baumann Cosmetic and Research Institute

Miami, Florida, 33137, United States

Location

Saint Louis University Dermatology

St Louis, Missouri, 63122, United States

Location

Skin Laser & Surgery Specialists of NY/NJ

Hackensack, New Jersey, 07601, United States

Location

Rhoda S. Narins, MD, PC

White Plains, New York, 10604, United States

Location

Aesthetic Solutions, PA

Chapel Hill, North Carolina, 27517, United States

Location

Related Links

MeSH Terms

Interventions

CannulaNeedles

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Results Point of Contact

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

Study Officials

  • Steve Abrams

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 19, 2018

Study Start

February 5, 2018

Primary Completion

May 29, 2018

Study Completion

August 2, 2018

Last Updated

August 5, 2019

Results First Posted

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(7)