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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418545
Recruitment Status : Completed
First Posted : February 1, 2018
Results First Posted : November 15, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Infraorbital Hollowing Device: JUVÉDERM VOLBELLA® XC injectable gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel for Correction of Infraorbital Hollowing
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : August 22, 2019

Arm Intervention/treatment
Experimental: JUVÉDERM VOLBELLA® XC
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
JUVÉDERM® VOLBELLA™ XC dermal filler injected into the infraorbital and adjacent area.

No Intervention: No-treatment Control
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.



Primary Outcome Measures :
  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 [ Time Frame: Baseline (Screening) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC arm) or Month 3 post randomization (No-treatment Control arm) ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline (Randomization) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC) or Month 3 post randomization (No-treatment Control arm) ]
    The evaluating investigator assessed a participant's global aesthetic improvement in the infraorbital area compared to Baseline using the 5-point GAIS where: 2=much improved (marked improvement in appearance), 1=improved (improvement in appearance, but a touch-up or retreatment is indicated), 0=no change (appearance is essentially the same as the original condition), -1=worse (appearance is worse than the original condition), -2=much worse (appearance is much worse than the original condition). The percentage of participants where the EI selected improved or much improved is reported.

  2. 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 [ Time Frame: Baseline (Randomization) to Month 3 post last treatment ]
    The participant assessed their global aesthetic improvement in the infraorbital area compared to Baseline using the 5-point GAIS where: 2=much improved (marked improvement in appearance), 1=improved (improvement in appearance, but a touch-up or retreatment is indicated), 0=no change (appearance is essentially the same as the original condition), -1=worse (appearance is worse than the original condition), -2=much worse (appearance is much worse than the original condition). The percentage of participants who selected improved or much improved is reported.

  3. 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 [ Time Frame: Baseline (Randomization) to Month 3 post last treatment ]
    Participants assessed their overall satisfaction by using 7 questions on the validated Appraisal of Lower Eyelids module of the FACE-Q™ questionnaire. Each question was answered on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, and 4=extremely bothered. The responses to the items were transformed to create a Rasch transformed score that ranges from 0=worst to 100=best. Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.



Information from the National Library of Medicine

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

INCLUSION CRITERIA:

  • 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

EXCLUSION CRITERIA:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418545


Locations
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United States, California
Christopher I. Zoumalan MD Inc.
Beverly Hills, California, United States, 90212
Steve Yoelin MD Medical Associate, Inc.
Newport Beach, California, United States, 92663
Cosmetic Laser Dermatology
San Diego, California, United States, 92121
Facesplus, Inc.
San Diego, California, United States, 92121
Art of Skin MD
Solana Beach, California, United States, 92128
United States, Florida
Steven Fagien M.D.F.A.C.S.
Boca Raton, Florida, United States, 33431
Center For Sight
Sarasota, Florida, United States, 34239
United States, Louisiana
Lupo Center for Aesthetic and General Dermatology
New Orleans, Louisiana, United States, 70124
United States, New Jersey
Image Dermatology, P.C.
Montclair, New Jersey, United States, 07042
United States, New York
Williams Plastic Surgery Specialists
Latham, New York, United States, 12110
United States, North Carolina
Aesthetic Solutions, PA.
Chapel Hill, North Carolina, United States, 27517
Duke Aesthetic Center
Durham, North Carolina, United States, 27708
United States, Tennessee
Brian Biesman, MD
Nashville, Tennessee, United States, 37203
United States, Texas
Precision Dermatology
Bellaire, Texas, United States, 77401
The Center for Skin Research
Houston, Texas, United States, 77056
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Steve Abrams Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] October 10, 2017
Statistical Analysis Plan  [PDF] December 16, 2019

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03418545    
Other Study ID Numbers: 1932-701-008
First Posted: February 1, 2018    Key Record Dates
Results First Posted: November 15, 2021
Last Update Posted: November 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes