Clinical trial NCT04414397: A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old
Official title: A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Temple Hollowing
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 205
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3
timeFrame: Baseline, Month 3 (Control Period)
measure: Number of Participants With Adverse Events
timeFrame: From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment
Secondary outcomes:
measure: Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3
timeFrame: Month 3 (Control Period)
measure: Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3
timeFrame: Month 3 (Control Period)
measure: Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3
timeFrame: Baseline, Month 3 (Control Period)
measure: Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire
timeFrame: Baseline, Month 3 (Control Period)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills /ID# 232967
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin MD Medical Associate Inc /ID# 232956
state: California
city: Boca Raton
country: United States
facility: Steven Fagien MD PA /ID# 232807
state: Florida
city: Bradenton
country: United States
facility: Bradenton Dermatologist /ID# 232822
state: Florida
city: Coral Gables
country: United States
facility: Hevia Cosmetic Dermatology /ID# 232824
state: Florida
city: Miami
country: United States
facility: Skin and Cancer Associates, LLP /ID# 232923
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC /ID# 233144
state: Florida
city: New Orleans
country: United States
facility: Delricht Research /ID# 233142
state: Louisiana
city: Glenn Dale
country: United States
facility: Callender Center for Clinical Research /ID# 233167
state: Maryland
city: Chestnut Hill
country: United States
facility: Skincare Physicians /ID# 233054
state: Massachusetts
city: Latham
country: United States
facility: Williams Plastic Surgery Specialists /ID# 232789
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions /ID# 232953
state: North Carolina
city: Nashville
country: United States
facility: The Practice of Brian S. Biesman MD PLLC /ID# 232662
state: Tennessee
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute /ID# 232971
state: Texas
city: San Juan
country: Puerto Rico
facility: Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 232706
Study officials:
affiliation: Allergan
name: ALLERGAN, INC.
role: STUDY_DIRECTOR
References: