An interventional study of Juvéderm® VOLUMA XC in Temple Hollowing, sponsored by Allergan. Terminated at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2018-10-18.
Sponsored by Allergan · Not applicable, Interventional, and Treatment
This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.
Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
-Has temple hollowing and is seeking restoration in the temple area.
Exclusion Criteria:
Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.
Device: Juvéderm® VOLUMA XC
No treatment is administered.
Juvéderm® VOLUMA XC hyaluronic acid injectable gel
Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator Using the Allergan Temple Hollowing Scale (ATHS)
The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Time frame: Change from Baseline to Month 3
Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.
Time frame: Month 3
Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS
The participant will assess their temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.
Time frame: Month 3
| Milestone | VOLUMA® XC Treatment | Control_No Treatment |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 0 |
| Not completed | 0 | 1 |
| Withdrew: Study was terminated | 0 | 1 |
The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
No measurements were reported for this outcome.
The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.
No measurements were reported for this outcome.
The participant will assess their temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.
No measurements were reported for this outcome.
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VOLUMA® XC Treatment | — | — | — |
| Control_No Treatment | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm. Due to confidentiality considerations, baseline data is not being provided to protect participant privacy.
| Age, Categorical(Participants) | VOLUMA® XC Treatment | Control_No Treatment | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Sex: Female, Male(participants) | VOLUMA® XC Treatment | Control_No Treatment | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Ethnicity (NIH/OMB)(Participants) | VOLUMA® XC Treatment | Control_No Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | — | — | — |
| Not Hispanic or Latino | — | — | — |
| Unknown or Not Reported | — | — | — |
| Race (NIH/OMB)(Participants) | VOLUMA® XC Treatment | Control_No Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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