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

NCT04414397 | Completed Phase 3 Results FDA Device

• 1 other identifier: 1878-702-008
• Study Type: interventional
• Target: 205
• Locations: 2 countries
• Sites: 15

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

Conditions

Temple Hollowing

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• 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)

• 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)

• Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3

  Baseline, Month 3 (Control Period)

• Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire

  Baseline, Month 3 (Control Period)

Study Arms (2)

No Treatment then JUVÉDERM® VOLUMA® XC

OTHER

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.

Device: JUVÉDERM® VOLUMA® XC; Other: No-treatment control

JUVÉDERM® VOLUMA® XC

EXPERIMENTAL

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.

Device: JUVÉDERM® VOLUMA® XC

Interventions

JUVÉDERM® VOLUMA® XC DEVICE

JUVÉDERM® VOLUMA® XC injectable gel

JUVÉDERM® VOLUMA® XC; No Treatment then JUVÉDERM® VOLUMA® XC

No-treatment control OTHER

Participants received no treatment for 3 months during the Control Period.

No Treatment then JUVÉDERM® VOLUMA® XC

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in general good health
• Participants seeking improvement of temple hollowing

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (15)

Skin Care and Laser Physicians of Beverly Hills /ID# 232967

Los Angeles, California, 90069, United States

Location

Steve Yoelin MD Medical Associate Inc /ID# 232956

Newport Beach, California, 92663, United States

Location

Steven Fagien MD PA /ID# 232807

Boca Raton, Florida, 33431, United States

Location

Bradenton Dermatologist /ID# 232822

Bradenton, Florida, 34209, United States

Location

Hevia Cosmetic Dermatology /ID# 232824

Coral Gables, Florida, 33134, United States

Location

Skin and Cancer Associates, LLP /ID# 232923

Miami, Florida, 33137-3254, United States

Location

Research Institute of the Southeast, LLC /ID# 233144

West Palm Beach, Florida, 33401-2712, United States

Location

Delricht Research /ID# 233142

New Orleans, Louisiana, 70115, United States

Location

Callender Center for Clinical Research /ID# 233167

Glenn Dale, Maryland, 20769-9182, United States

Location

Skincare Physicians /ID# 233054

Chestnut Hill, Massachusetts, 02467, United States

Location

Williams Plastic Surgery Specialists /ID# 232789

Latham, New York, 12110, United States

Location

Aesthetic Solutions /ID# 232953

Chapel Hill, North Carolina, 27517-9901, United States

Location

The Practice of Brian S. Biesman MD PLLC /ID# 232662

Nashville, Tennessee, 37203, United States

Location

Dallas Plastic Surgery Institute /ID# 232971

Dallas, Texas, 75231, United States

Location

Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 232706

San Juan, 00917, Puerto Rico

Location

Related Links

• Related Info

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN, INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: May 28, 2020
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (14); PR (1)