Clinical trial NCT03166618: Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
Official title: A Multicenter, Single-Blind, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Temple Hollowing
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-05-25
Enrollment: 1
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Change from Baseline to Month 3
Secondary outcomes:
measure: Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 3
measure: Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS
timeFrame: Month 3
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills
state: California
Study officials:
affiliation: Allergan
name: Nikki Amaratunge
role: STUDY_DIRECTOR
References: