Trial Outcomes & Findings for Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing (NCT NCT03166618)
NCT ID: NCT03166618
Last Updated: 2018-10-18
Results Overview
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.
TERMINATED
NA
1 participants
Change from Baseline to Month 3
2018-10-18
Participant Flow
Up to 189 subjects were planned; 1 subject was enrolled but did not receive treatment.
Participant milestones
| Measure |
VOLUMA® XC Treatment
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.
|
Control_No Treatment
No treatment is administered.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
VOLUMA® XC Treatment
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.
|
Control_No Treatment
No treatment is administered.
|
|---|---|---|
|
Overall Study
Study was Terminated
|
0
|
1
|
Baseline Characteristics
Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Change from Baseline to Month 3Population: Up to 189 subjects were planned; 1 subject was enrolled in the control\_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3Population: Up to 189 subjects were planned; 1 subject was enrolled in the control\_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3Population: Up to 189 subjects were planned; 1 subject was enrolled in the control\_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.
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.
Outcome measures
Outcome data not reported
Adverse Events
VOLUMA® XC Treatment
Control_No Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The TI is responsible for compliance with the protocol at the investigational site. A representative of Allergan will make frequent contact with the TI and his/her research staff and will conduct regular monitoring visits at the site to review subject and device accountability records for compliance with the protocol
- Publication restrictions are in place
Restriction type: OTHER