A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old
- Conditions
- Temple Hollowing
- Interventions
- Device: JUVÉDERM® VOLUMA® XCOther: No-treatment control
- Registration Number
- NCT04414397
- Lead Sponsor
- Allergan
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
- Participants in general good health
- Participants seeking improvement of temple hollowing
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JUVÉDERM® VOLUMA® XC 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. No Treatment then JUVÉDERM® VOLUMA® XC 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. No Treatment then JUVÉDERM® VOLUMA® XC No-treatment control 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.
- Primary Outcome Measures
Name Time Method 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 Baseline, Month 3 (Control Period) The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Number of Participants With Adverse Events 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 An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.
- Secondary Outcome Measures
Name Time Method 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 Month 3 (Control Period) Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
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 Month 3 (Control Period) The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 Baseline, Month 3 (Control Period) The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire Baseline, Month 3 (Control Period) The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
Trial Locations
- Locations (15)
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
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
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
Delricht Research /ID# 233142
🇺🇸New Orleans, Louisiana, United States
The Practice of Brian S. Biesman MD PLLC /ID# 232662
🇺🇸Nashville, Tennessee, United States
Callender Center for Clinical Research /ID# 233167
🇺🇸Glenn Dale, Maryland, United States
Williams Plastic Surgery Specialists /ID# 232789
🇺🇸Latham, New York, United States
Hevia Cosmetic Dermatology /ID# 232824
🇺🇸Coral Gables, Florida, United States
Skincare Physicians /ID# 233054
🇺🇸Chestnut Hill, Massachusetts, United States
Aesthetic Solutions /ID# 232953
🇺🇸Chapel Hill, North Carolina, United States