A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing

NCT03418545 | Completed Phase 3 Results FDA Device

• 1 other identifier: 1932-701-008
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 15

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM® VOLBELLA™ XC in adult participants seeking correction of hollowing of the tear troughs.

Conditions

Infraorbital Hollowing

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least a 1-point Improvement Change From Baseline on the Allergan Infraorbital Hollows Scale (AIHS) Based on Evaluating Investigator's (EI) Assessment

  The evaluating investigator assessed hollowing in both infraorbital areas using the 5-point photonumeric AIHS where: 0=none (no visible hollowing or volume loss medially or laterally), 1=minimal (presence of hollowing with some volume loss medial to the mid-pupillary line; smooth lateral lid-cheek transition), 2=moderate (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss; smooth lateral lid-cheek transition with mild volume loss), 3=severe (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss creating a defined groove along the lid-cheek junction), 4=extreme (defined hollowing extends from medial to lateral canthus; severe volume loss creates a marked step along the lid-cheek junction). The percentage of participants with at least a 1-point improvement change (decrease) in the AIHS is reported.

  Baseline (Screening) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC arm) or Month 3 post randomization (No-treatment Control arm)

Secondary Outcomes (3)

• Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on EI's Assessment of the Global Aesthetic Improvement Scale (GAIS) at Month 3 After the Last Treatment

  Baseline (Randomization) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC) or Month 3 post randomization (No-treatment Control arm)

• Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on Participant's Assessment of the GAIS at Month 3 After the Last Treatment

  Baseline (Randomization) to Month 3 post last treatment

• Mean Change From Baseline in Rasch-Transformed Score Based on Participant Responses on the FACE-Q™ Appraisal of Lower Eyelids Questionnaire to Month 3 After the Last Treatment

  Baseline (Randomization) to Month 3 post last treatment

Study Arms (2)

JUVÉDERM VOLBELLA® XC

EXPERIMENTAL

JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 milliliter (mL) per side was injected for initial and touch-up treatments combined.

Device: JUVÉDERM VOLBELLA® XC injectable gel

No-treatment Control

NO INTERVENTION

Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period. Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.

Interventions

JUVÉDERM VOLBELLA® XC injectable gel DEVICE

JUVÉDERM® VOLBELLA™ XC dermal filler injected into the infraorbital and adjacent area.

JUVÉDERM VOLBELLA® XC

Eligibility Criteria

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

You may qualify if:

• Age 22 or over and in good general health
• Has "Moderate" or "Severe" infraorbital hollowing (grade 2 or 3 on the Allergan Infraorbital Hollows Scale (AIHS)) for each eye as assessed by the Evaluating Investigator (i.e., both eyes must qualify but do not need to have the same score)
• Is able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable if they will be used for all subject self-assessments)
• Ability to follow study instructions and likely to complete all required visits
• Written informed consent has been obtained

You may not qualify if:

• Has hyperpigmentation in the infraorbital area (does not include dark circles under the eyes not due to hyperpigmentation)
• Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
• Has ever undergone fat injections above the subnasale or is planning to undergo this procedure during the study
• Has tattoos, piercings, facial hair (i.e., beard, mustache), or scars that would interfere with visual assessment of the infraorbital hollows
• Has undergone volume augmentation with semipermanent dermal fillers (e.g., calcium hydroxyapatite, poly-L-lactic acid) or temporary dermal fillers in the malar area, temples, or around the eyes within 12 months before enrollment or is planning to undergo such treatment during the study
• Has begun using any new over-the-counter or prescription oral or topical, anti-wrinkle products within 30 days before enrollment or is planning to begin using such products during the study. Subjects who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study)
• Has active or recurrent inflammation or infection in either eye
• Has active autoimmune disease
• Females who are pregnant, nursing, or planning a pregnancy
• Is an employee (or a relative of an employee) of the treating investigator (TI), evaluating investigator (EI), or Allergan, or a representative of Allergan
• Has a condition or is in a situation which in the TI's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

Sponsors & Collaborators

• Allergan: lead

Study Sites (15)

Christopher I. Zoumalan MD Inc.

Beverly Hills, California, 90212, United States

Location

Steve Yoelin MD Medical Associate, Inc.

Newport Beach, California, 92663, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Facesplus, Inc.

San Diego, California, 92121, United States

Location

Art of Skin MD

Solana Beach, California, 92128, United States

Location

Steven Fagien M.D.F.A.C.S.

Boca Raton, Florida, 33431, United States

Location

Center For Sight

Sarasota, Florida, 34239, United States

Location

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, 70124, United States

Location

Image Dermatology, P.C.

Montclair, New Jersey, 07042, United States

Location

Williams Plastic Surgery Specialists

Latham, New York, 12110, United States

Location

Aesthetic Solutions, PA.

Chapel Hill, North Carolina, 27517, United States

Location

Duke Aesthetic Center

Durham, North Carolina, 27708, United States

Location

Brian Biesman, MD

Nashville, Tennessee, 37203, United States

Location

Precision Dermatology

Bellaire, Texas, 77401, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Related Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Steve Abrams

  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: January 17, 2018
• First Posted: February 1, 2018
• Study Start: January 26, 2018
• Primary Completion: October 17, 2018
• Study Completion: August 22, 2019
• Last Updated: November 15, 2021
• Results First Posted: November 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)