Temple Hollowing
Conditions
Brief summary
This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.
Interventions
DEVICEJuvéderm® VOLUMA XC
Juvéderm® VOLUMA XC hyaluronic acid injectable gel
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Has temple hollowing and is seeking restoration in the temple area.
Exclusion criteria
* Has temple hollowing due to due to trauma, congenital malformations, or lipodystrophy * Has received permanent facial implants in the face or neck * Has undergone fat injections * Has tattoos, piercings, facial hair or scars that would interfere with visual assessment of the temple * Has undergone semipermanent dermal filler treatment in the temple or mid-face within the past 36 months * Has undergone dermal filler injections above the subnasale within the past 24 months * Has temporal arteritis or history of temporal arteritis * Has temporomandibular joint dysfunction * Has eye inflammation or infection * Has a history of detached retina, retinal vascular occlusion, narrow angle glaucoma, or neovascular eye disease * Has ever received a facelift, browlift, or facial reconstructive surgery * Has undergone mesotherapy or cosmetic treatment (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck or botulinum toxin injections within the past 6 months * Has experienced trauma to the temple within the past 6 months or has residual deficiencies, deformities, or scarring * Has a tendency to develop hypertrophic scarring * Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein * Has porphyria or untreated epilepsy * Has active autoimmune disease * Has current cutaneous or mucosal inflammatory or infectious processes * Is on a lidocaine, anticoagulation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Change from Baseline to Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Improved or Much Improved as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | Month 3 | 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. |
| Percentage of Participants Improved or Much Improved as Assessed by the Participant Using the GAIS | Month 3 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Up to 189 subjects were planned; 1 subject was enrolled but did not receive treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| Control_No Treatment No treatment is administered. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study was Terminated | 0 | 1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
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
Population: 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.
Secondary
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
Population: 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.
Secondary
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
Population: 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.