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

Study Identifier
1878-702-008
CT.gov Identifier
NCT04414397
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female & Male
    Age
    22+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants in general good health * Participants seeking improvement of temple hollowing
    Exclusion Criteria:
    * 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

    Protocol 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

    Study Locations

    Location
    Status
    Location
    Skin Care and Laser Physicians of Beverly Hills /ID# 232967
    Los Angeles, California, United States, 90069
    Status
    Not applicable
    Location
    Steve Yoelin MD Medical Associate Inc /ID# 232956
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Steven Fagien MD PA /ID# 232807
    Boca Raton, Florida, United States, 33431
    Status
    Not applicable
    Location
    Bradenton Dermatologist /ID# 232822
    Bradenton, Florida, United States, 34209
    Status
    Not applicable
    Location
    Hevia Cosmetic Dermatology /ID# 232824
    Coral Gables, Florida, United States, 33134
    Status
    Not applicable
    Location
    Skin and Cancer Associates, LLP /ID# 232923
    Miami, Florida, United States, 33137-3254
    Status
    Not applicable
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