Status:
COMPLETED
A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old
Lead Sponsor:
Allergan
Conditions:
Temple Hollowing
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- Participants in general good health
- Participants seeking improvement of temple hollowing
Exclusion
- 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
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2022
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04414397
Start Date
May 28 2020
End Date
October 17 2022
Last Update
April 25 2024
Active Locations (15)
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1
Skin Care and Laser Physicians of Beverly Hills /ID# 232967
Los Angeles, California, United States, 90069
2
Steve Yoelin MD Medical Associate Inc /ID# 232956
Newport Beach, California, United States, 92663
3
Steven Fagien MD PA /ID# 232807
Boca Raton, Florida, United States, 33431
4
Bradenton Dermatologist /ID# 232822
Bradenton, Florida, United States, 34209