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

• ClinicalTrials.gov Identifier: NCT04414397
• Recruitment Status: Completed
• First Posted: June 4, 2020
• Results First Posted: April 25, 2024
• Last Update Posted: April 25, 2024
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

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

Condition or disease	Intervention/treatment	Phase
Temple Hollowing	Device: JUVÉDERM® VOLUMA® XC; Other: No-treatment control	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 28, 2020
• Actual Primary Completion Date: October 17, 2022
• Actual Study Completion Date: October 17, 2022

Arms and Interventions

Arm	Intervention/treatment
No Treatment then 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.	Device: JUVÉDERM® VOLUMA® XC; JUVÉDERM® VOLUMA® XC injectable gel; Other: No-treatment control; Participants received no treatment for 3 months during the Control Period.
Experimental: 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.	Device: JUVÉDERM® VOLUMA® XC; JUVÉDERM® VOLUMA® XC injectable gel

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 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.
2. Number of Participants With Adverse Events [ Time Frame: 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 :

1. 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 [ Time Frame: 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.
2. 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 [ Time Frame: 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.
3. Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 [ Time Frame: 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.
4. Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

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

Los Angeles, California, United States, 90069

Steve Yoelin MD Medical Associate Inc /ID# 232956

Newport Beach, California, United States, 92663

United States, Florida

Steven Fagien MD PA /ID# 232807

Boca Raton, Florida, United States, 33431

Bradenton Dermatologist /ID# 232822

Bradenton, Florida, United States, 34209

Hevia Cosmetic Dermatology /ID# 232824

Coral Gables, Florida, United States, 33134

Skin and Cancer Associates, LLP /ID# 232923

Miami, Florida, United States, 33137-3254

Research Institute of the Southeast, LLC /ID# 233144

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

United States, Louisiana

Delricht Research /ID# 233142

New Orleans, Louisiana, United States, 70115

United States, Maryland

Callender Center for Clinical Research /ID# 233167

Glenn Dale, Maryland, United States, 20769-9182

United States, Massachusetts

Skincare Physicians /ID# 233054

Chestnut Hill, Massachusetts, United States, 02467

United States, New York

Williams Plastic Surgery Specialists /ID# 232789

Latham, New York, United States, 12110

United States, North Carolina

Aesthetic Solutions /ID# 232953

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

United States, Tennessee

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

Nashville, Tennessee, United States, 37203

United States, Texas

Dallas Plastic Surgery Institute /ID# 232971

Dallas, Texas, United States, 75231

Puerto Rico

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

San Juan, Puerto Rico, 00917

Sponsors and Collaborators

Allergan

Investigators

• Study Director: ALLERGAN, INC.; Allergan

  Study Documents (Full-Text)

Documents provided by Allergan:

Study Protocol  [PDF] May 10, 2021

Statistical Analysis Plan  [PDF] September 22, 2021

More Information

Additional Information:

Related Info 

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT04414397
• Other Study ID Numbers: 1878-702-008
• First Posted: June 4, 2020
• Results First Posted: April 25, 2024
• Last Update Posted: April 25, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (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/
• URL: https://vivli.org/ourmember/abbvie/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No