Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
NCT ID: NCT03166618
Last Updated: 2018-10-18
Study Results
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View full resultsBasic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2017-04-24
2017-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Juvéderm® VOLUMA XC
Juvéderm® VOLUMA XC hyaluronic acid injectable gel
Control_No Treatment
No treatment is administered.
No interventions assigned to this group
Interventions
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Juvéderm® VOLUMA XC
Juvéderm® VOLUMA XC hyaluronic acid injectable gel
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
22 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Nikki Amaratunge
Role: STUDY_DIRECTOR
Allergan
Locations
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Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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More Information
Other Identifiers
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VOLUMA-007
Identifier Type: -
Identifier Source: org_study_id
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