Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Infraorbital Hollowing
Intervention Device: JUVÉDERM VOLBELLA® XC injectable gel
Enrollment 163
Recruitment Details  
Pre-assignment Details A total of 163 participants were enrolled in the study (signed the informed consent) out of which 140 were randomized to receive JUVÉDERM® VOLBELLA™ XC (treatment group) or no treatment (control group) in 3:1 ratio.
Arm/Group Title No-treatment Control JUVÉDERM® VOLBELLA™ XC
Hide Arm/Group Description Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control 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. 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 mL per side was injected for initial and touch-up treatments combined.
Period Title: Overall Study
Started 35 105
Safety Population [1] 34 105
Received Optional or Repeat Treatment [2] 29 37
Completed 30 94
Not Completed 5 11
Reason Not Completed
Withdrawal by Participant             2             4
Lost to Follow-up             3             5
Reason Not Specified             0             1
Missing Completion Status             0             1
[1]
Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group.
[2]
Participants randomized to the No-treatment Control group who received optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel after Month 3 and participants randomized to the JUVÉDERM® VOLBELLA™ XC arm who received repeat treatment with JUVÉDERM® VOLBELLA™ XC injectable gel 12 months after the initial treatment.
Arm/Group Title No-treatment Control JUVÉDERM® VOLBELLA™ XC Total
Hide Arm/Group Description Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control 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. 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 mL per side was injected for initial and touch-up treatments combined. Total of all reporting groups
Overall Number of Baseline Participants 32 103 135
Hide Baseline Analysis Population Description
Modified Intent-to-treat (mITT) Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group), received at least 1 study device treatment and had a Baseline and at least 1 posttreatment assessment of the primary effectiveness variable and participants who were randomized to the control group and had a Baseline and at least 1 follow-up assessment of the primary effectiveness variable.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 103 participants 135 participants
41.0  (10.85) 44.9  (10.58) 43.9  (10.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 103 participants 135 participants
Female
31
  96.9%
93
  90.3%
124
  91.9%
Male
1
   3.1%
10
   9.7%
11
   8.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 103 participants 135 participants
Hispanic or Latino
7
  21.9%
11
  10.7%
18
  13.3%
Not Hispanic or Latino
25
  78.1%
92
  89.3%
117
  86.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 103 participants 135 participants
American Indian or Alaska Native
1
   3.1%
3
   2.9%
4
   3.0%
Asian
2
   6.3%
1
   1.0%
3
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   6.3%
16
  15.5%
18
  13.3%
White
27
  84.4%
81
  78.6%
108
  80.0%
More than one race
0
   0.0%
2
   1.9%
2
   1.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline (Screening) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC arm) or Month 3 post randomization (No-treatment Control arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-treat (mITT) Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group), received at least 1 study device treatment and had a Baseline and at least 1 posttreatment assessment of the primary effectiveness variable and participants who were randomized to the control group and had a Baseline and at least 1 follow-up assessment of the primary effectiveness variable.
Arm/Group Title No-treatment Control JUVÉDERM® VOLBELLA™ XC
Hide Arm/Group Description:
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control 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.
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 mL per side was injected for initial and touch-up treatments combined.
Overall Number of Participants Analyzed 32 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.6
(3.0 to 28.2)
83.1
(75.8 to 90.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No-treatment Control, JUVÉDERM® VOLBELLA™ XC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value and 95% CI are computed by pooling 5 imputed datasets using PROC MIANALYZE in SAS with normal approximation. The p-value and 95% CI for each imputed data set is based on the Fisher's exact test and the Wald test, respectively.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 67.5
Confidence Interval (2-Sided) 95%
52.9 to 82.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline (Randomization) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC) or Month 3 post randomization (No-treatment Control arm)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group), received at least 1 study device treatment and had a Baseline and at least 1 posttreatment assessment of the primary effectiveness variable and participants who were randomized to the control group and had a Baseline and at least 1 follow-up assessment of the primary effectiveness variable. Overall number analyzed are the participants with data available for analyses.
Arm/Group Title No-treatment Control JUVÉDERM® VOLBELLA™ XC
Hide Arm/Group Description:
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control 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.
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 mL per side was injected for initial and touch-up treatments combined.
Overall Number of Participants Analyzed 32 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.5
(3.5 to 29.0)
86.0
(77.6 to 92.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No-treatment Control, JUVÉDERM® VOLBELLA™ XC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 73.5
Confidence Interval (2-Sided) 95%
60.2 to 86.8
Estimation Comments The 95% CI is based on the Wald test.
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline (Randomization) to Month 3 post last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
VOLBELLA™ Initially Treated (VIT) Population included participants who were randomized and received VOLBELLA™ treatment at the beginning of the Control Period. Overall number analyzed are the participants with data available for analyses. The GAIS assessed by the participant was only completed by participants in the JUVÉDERM® VOLBELLA™ XC arm.
Arm/Group Title JUVÉDERM® VOLBELLA™ XC
Hide Arm/Group Description:
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 mL per side was injected for initial and touch-up treatments combined.
Overall Number of Participants Analyzed 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.0
(75.3 to 90.6)
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline (Randomization) to Month 3 post last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
VIT Population included participants who were randomized and received VOLBELLA™ treatment at the beginning of the Control Period. Overall number analyzed are the participants with data available for analyses at Baseline. Number analyzed is the number of participants with data available for analyses at a given time point. The FACE-Q™ was only completed by participants in the JUVÉDERM® VOLBELLA™ XC arm.
Arm/Group Title JUVÉDERM® VOLBELLA™ XC
Hide Arm/Group Description:
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 mL per side was injected for initial and touch-up treatments combined.
Overall Number of Participants Analyzed 104
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 104 participants
54.5  (14.23)
Change From Baseline at Month 3 Number Analyzed 101 participants
17.8  (19.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JUVÉDERM® VOLBELLA™ XC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A 2-sided paired t-test at the 5% level was performed to demonstrate that the mean overall satisfaction score at Month 3 was statistically greater than that at Baseline for the treatment group.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame From Randomization to the end of the study (JUVÉDERM® VOLBELLA™ XC: Up to 14 months; No-treatment Control: Up to 13 months)
Adverse Event Reporting Description All-Cause Mortality: All randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included participants who were randomized to study treatment (JUVÉDERM® VOLBELLA™ XC treatment group) and received at least 1 study device treatment and participants who were randomized to the control group. The data for adverse events is added as per treatment received by the participants.
 
Arm/Group Title No-treatment Control JUVÉDERM® VOLBELLA™ Initial Treatment JUVÉDERM® VOLBELLA™ Optional Treatment JUVÉDERM® VOLBELLA™ Repeat Treatment
Hide Arm/Group Description Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period (Control 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. JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants randomized to the No-treatment Control group received optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel, injected into the infraorbital and adjacent area Month 3 after Randomization as determined by the investigator. Participants randomized to the JUVÉDERM® VOLBELLA™ XC arm received JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area 12 months after the last treatment as determined by the investigator.
All-Cause Mortality
No-treatment Control JUVÉDERM® VOLBELLA™ Initial Treatment JUVÉDERM® VOLBELLA™ Optional Treatment JUVÉDERM® VOLBELLA™ Repeat Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/105 (0.00%)   0/29 (0.00%)   0/37 (0.00%) 
Hide Serious Adverse Events
No-treatment Control JUVÉDERM® VOLBELLA™ Initial Treatment JUVÉDERM® VOLBELLA™ Optional Treatment JUVÉDERM® VOLBELLA™ Repeat Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   1/105 (0.95%)   0/29 (0.00%)   1/37 (2.70%) 
Infections and infestations         
Mastitis  1  0/34 (0.00%)  1/105 (0.95%)  0/29 (0.00%)  0/37 (0.00%) 
Injury, poisoning and procedural complications         
Tooth Fracture  1  0/34 (0.00%)  0/105 (0.00%)  0/29 (0.00%)  1/37 (2.70%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
No-treatment Control JUVÉDERM® VOLBELLA™ Initial Treatment JUVÉDERM® VOLBELLA™ Optional Treatment JUVÉDERM® VOLBELLA™ Repeat Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/105 (0.00%)   3/29 (10.34%)   0/37 (0.00%) 
General disorders         
Injection site bruising  1  0/34 (0.00%)  0/105 (0.00%)  2/29 (6.90%)  0/37 (0.00%) 
Injection site swelling  1  0/34 (0.00%)  0/105 (0.00%)  2/29 (6.90%)  0/37 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03418545    
Other Study ID Numbers: 1932-701-008
First Submitted: January 17, 2018
First Posted: February 1, 2018
Results First Submitted: October 15, 2021
Results First Posted: November 15, 2021
Last Update Posted: November 15, 2021