N/A N=60 Randomized Single-blind Treatment

A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

Age-related Volume Deficit in the Mid-face

Bottom Line

View on ClinicalTrials.gov: NCT03438266 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score — 3.5; 3.5; -1.8; -1.9 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: JUVÉDERM VOLUMA® XC injectable gel with cannula (Device); JUVÉDERM VOLUMA® XC injectable gel with needle (Device)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Allergan
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score	3.5; 3.5; -1.8; -1.9	—
SECONDARY Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score	93.3; 95.0	—
SECONDARY Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score	32.1; 55.5	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	7	—

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.

Eligibility Criteria

Inclusion Criteria

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);

Exclusion criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03438266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.