A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

Completed · Phase 3

Conditions studied: Temple Hollowing

In brief

The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing

Key facts

Study ID

NCT04414397

Run by

Allergan

People needed

205

Starts

2020-05-28

Expected to finish

2022-10-17

Last updated by the study team

2024-04-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants in general good health
• Participants seeking improvement of temple hollowing

You may not qualify if…

• Temple hollowing due to trauma, congenital malformations, or lipodystrophy
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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