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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

Tracking Information
First Submitted Date  ICMJE January 17, 2018
First Posted Date  ICMJE February 1, 2018
Results First Submitted Date  ICMJE October 15, 2021
Results First Posted Date  ICMJE November 15, 2021
Last Update Posted Date November 15, 2021
Actual Study Start Date  ICMJE January 26, 2018
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2021)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2021)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing
Official Title  ICMJE A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel for Correction of Infraorbital Hollowing
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infraorbital Hollowing
Intervention  ICMJE Device: JUVÉDERM VOLBELLA® XC injectable gel
JUVÉDERM® VOLBELLA™ XC dermal filler injected into the infraorbital and adjacent area.
Study Arms  ICMJE
  • 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.
    Intervention: Device: JUVÉDERM VOLBELLA® XC injectable gel
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2021)
163
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 22, 2019
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418545
Other Study ID Numbers  ICMJE 1932-701-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Allergan
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Allergan
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steve Abrams Allergan
PRS Account Allergan
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP