A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing
- Conditions
- Infraorbital Hollowing
- Interventions
- Device: JUVÉDERM VOLBELLA® XC injectable gel
- Registration Number
- NCT03418545
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JUVÉDERM VOLBELLA® XC JUVÉDERM VOLBELLA® XC injectable gel 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.
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method 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 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.
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 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.
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) 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.
Trial Locations
- Locations (15)
Steve Yoelin MD Medical Associate, Inc.
🇺🇸Newport Beach, California, United States
Cosmetic Laser Dermatology
🇺🇸San Diego, California, United States
Facesplus, Inc.
🇺🇸San Diego, California, United States
Center For Sight
🇺🇸Sarasota, Florida, United States
Duke Aesthetic Center
🇺🇸Durham, North Carolina, United States
Steven Fagien M.D.F.A.C.S.
🇺🇸Boca Raton, Florida, United States
Brian Biesman, MD
🇺🇸Nashville, Tennessee, United States
The Center for Skin Research
🇺🇸Houston, Texas, United States
Christopher I. Zoumalan MD Inc.
🇺🇸Beverly Hills, California, United States
Art of Skin MD
🇺🇸Solana Beach, California, United States
Image Dermatology, P.C.
🇺🇸Montclair, New Jersey, United States
Lupo Center for Aesthetic and General Dermatology
🇺🇸New Orleans, Louisiana, United States
Williams Plastic Surgery Specialists
🇺🇸Latham, New York, United States
Aesthetic Solutions, PA.
🇺🇸Chapel Hill, North Carolina, United States
Precision Dermatology
🇺🇸Bellaire, Texas, United States