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

Temple Hollowing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414397
• Other study ID #: 1878-702-008
• Status: Completed
• Phase: Phase 3
• Start date: May 28, 2020
• Est. completion date: October 17, 2022

Study information

• Verified date: March 2024
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 17, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Temple Hollowing

Intervention

Device:
• JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC injectable gel

Other:
• No-treatment control
Participants received no treatment for 3 months during the Control Period.

Locations

Country	Name	City	State
Puerto Rico	Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 232706	San Juan
United States	Steven Fagien MD PA /ID# 232807	Boca Raton	Florida
United States	Bradenton Dermatologist /ID# 232822	Bradenton	Florida
United States	Aesthetic Solutions /ID# 232953	Chapel Hill	North Carolina
United States	Skincare Physicians /ID# 233054	Chestnut Hill	Massachusetts
United States	Hevia Cosmetic Dermatology /ID# 232824	Coral Gables	Florida
United States	Dallas Plastic Surgery Institute /ID# 232971	Dallas	Texas
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	Skin Care and Laser Physicians of Beverly Hills /ID# 232967	Los Angeles	California
United States	Skin and Cancer Associates, LLP /ID# 232923	Miami	Florida
United States	The Practice of Brian S. Biesman MD PLLC /ID# 232662	Nashville	Tennessee
United States	Delricht Research /ID# 233142	New Orleans	Louisiana
United States	Steve Yoelin MD Medical Associate Inc /ID# 232956	Newport Beach	California
United States	Research Institute of the Southeast, LLC /ID# 233144	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Month 3 (Control Period)
Primary	Number of Participants With Adverse Events	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.	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	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	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.	Month 3 (Control Period)
Secondary	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	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.	Month 3 (Control Period)
Secondary	Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3	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.	Baseline, Month 3 (Control Period)
Secondary	Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire	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.	Baseline, Month 3 (Control Period)

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