Clinical trial NCT01029535: Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mid-face Volume Deficiency
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-12-10
Enrollment: 103
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52
timeFrame: Baseline, Week 8, Week 52
measure: Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78
timeFrame: Baseline, Week 8, Week 78
measure: Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104
timeFrame: Baseline, Week 8, Week 104
measure: Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52
timeFrame: Baseline, Week 8, Week 52
measure: Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78
timeFrame: Baseline, Week 8, Week 78
measure: Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104
timeFrame: Baseline, Week 8, Week 104
measure: Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52
timeFrame: Baseline, Week 8, Week 52
measure: Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78
timeFrame: Baseline, Week 8, Week 78
measure: Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104
timeFrame: Baseline, Week 8, Week 104
Secondary outcomes:
measure: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
timeFrame: Baseline, Weeks 4, 8, 52, 78 and 104
measure: Change From Baseline in the MFVDS Score
timeFrame: Baseline, Weeks 4, 8, 52, 78 and 104
measure: Physician Assessment of Global Aesthetic Improvement Score (GAIS)
timeFrame: Baseline, Weeks 4, 8, 52, 78 and 104
measure: Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
timeFrame: Baseline, Weeks 4, 8, 52, 78 and 104
measure: Change From Baseline in the Subject's Self-Perception of Age (SPA)
timeFrame: Baseline, Weeks 4, 8, 52, 78 and 104
measure: Percentage of Participants Satisfied or Very Satisfied With the Treatment
timeFrame: Week 8
Other outcomes:
Locations:
city: Sydney
country: Australia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.