A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old
NCT ID: NCT04414397
Last Updated: 2024-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
205 participants
INTERVENTIONAL
2020-05-28
2022-10-17
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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No Treatment then JUVÉDERM® VOLUMA® XC
Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.
JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC injectable gel
No-treatment control
Participants received no treatment for 3 months during the Control Period.
JUVÉDERM® VOLUMA® XC
Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC injectable gel
Interventions
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JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC injectable gel
No-treatment control
Participants received no treatment for 3 months during the Control Period.
Eligibility Criteria
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Inclusion Criteria
* Participants seeking improvement of temple hollowing
Exclusion Criteria
* Temporomandibular joint dysfunction or any other jaw issues
* Recurrent temporal headaches such as temporal tendinitis migraine
* Active autoimmune disease
* History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
* Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
* Fat injection or permanent facial implants anywhere in the face
* Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
* Temporary dermal filler injections above the subnasale within 24 months before enrollment
* Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment
* Botulinum toxin treatment above the subnasale within 6 months before enrollment
* Females who are pregnant, nursing, or planning a pregnancy
22 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN, INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Skin Care and Laser Physicians of Beverly Hills /ID# 232967
Los Angeles, California, United States
Steve Yoelin MD Medical Associate Inc /ID# 232956
Newport Beach, California, United States
Steven Fagien MD PA /ID# 232807
Boca Raton, Florida, United States
Bradenton Dermatologist /ID# 232822
Bradenton, Florida, United States
Hevia Cosmetic Dermatology /ID# 232824
Coral Gables, Florida, United States
Skin and Cancer Associates, LLP /ID# 232923
Miami, Florida, United States
Research Institute of the Southeast, LLC /ID# 233144
West Palm Beach, Florida, United States
Delricht Research /ID# 233142
New Orleans, Louisiana, United States
Callender Center for Clinical Research /ID# 233167
Glenn Dale, Maryland, United States
Skincare Physicians /ID# 233054
Chestnut Hill, Massachusetts, United States
Williams Plastic Surgery Specialists /ID# 232789
Latham, New York, United States
Aesthetic Solutions /ID# 232953
Chapel Hill, North Carolina, United States
The Practice of Brian S. Biesman MD PLLC /ID# 232662
Nashville, Tennessee, United States
Dallas Plastic Surgery Institute /ID# 232971
Dallas, Texas, United States
Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 232706
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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1878-702-008
Identifier Type: -
Identifier Source: org_study_id
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