N/A N=103 Treatment

Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency

Mid-face Volume Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT01029535 ↗

Enrolled (actual)

103

Serious AEs

0.5%

Results posted

Feb 2013

Primary outcome: Primary: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4 — 97.06 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cross-linked hyaluronic acid gel (Device)
Age: Adult · 30+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4	97.06	—
PRIMARY Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8	97.98	—
PRIMARY Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4	100	—
PRIMARY Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8	100	—
PRIMARY Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4	92.23	—
PRIMARY Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8	95.96	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52	40.8	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78	30.1	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104	38.8	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52	41.7	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78	36.9	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104	36.9	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52	32.0	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78	28.2	—
PRIMARY Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104	29.1	—
SECONDARY Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)	35.92; 45.45; 36.76; 42.68; 48.61; 34.95	—
SECONDARY Change From Baseline in the MFVDS Score	3.45; 1.58; 2.03; 1.68; 1.44; 1.72	—
SECONDARY Physician Assessment of Global Aesthetic Improvement Score (GAIS)	1.35; 1.76; 1.13; 0.85; 1.14	—
SECONDARY Subject's Assessment of Global Aesthetic Improvement Score (GAIS)	1.31; 1.55; 1.01; 0.79; 0.97	—
SECONDARY Change From Baseline in the Subject's Self-Perception of Age (SPA)	-3.03; -3.74; -3.15; -2.88; -3.85	—
SECONDARY Percentage of Participants Satisfied or Very Satisfied With the Treatment	66.7; 24.2	—

Summary

This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.

Eligibility Criteria

Inclusion Criteria

Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician

Exclusion Criteria

Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.
Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.
Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study
Subjects with a history of alcoholism or drug abuse or dependence

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01029535). 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.