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Trial record 1 of 1 for:    NCT00978042
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Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation

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ClinicalTrials.gov Identifier: NCT00978042
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : February 13, 2014
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Condition Mid-facial Volume Deficit Related to Aging
Intervention Device: Juvéderm® VOLUMA XC
Enrollment 345
Recruitment Details 345 participants were originally recruited for treatment at 15 sites.
Pre-assignment Details Prior to randomization, 16 patients were excluded as screen failures and the first two participants per site (30 total) were treated as run-in participants. Of the 299 randomized participants, 17 were discontinued prior to treatment, leaving a “modified intent-to-treat” population of 282 participants (235 in Treatment Arm and 47 in Control Arm).
Arm/Group Title VOLUMA® XC Treatment Arm Control Arm_No Treatment Then VOLUMA® XC
Hide Arm/Group Description Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable. No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
Period Title: Initial Treatment Period
Started 235 47
MITT_treated With VOLUMA XC 235 35
Completed 174 [1] 32
Not Completed 61 15
Reason Not Completed
Treated in Error             0             3
Ineligibility             1             0
Lost to Follow-up             21             3
Adverse Event             2             0
Discontinuation by Investigator/Sponsor             2             0
Consent withdrawn             22             9
Other Miscellaneous Reasons             13             0
[1]
Completed 24-month Follow-Up
Period Title: Received Repeat Treatment
Started 141 [1] 26 [1]
Completed 98 [2] 23
Not Completed 43 3
[1]
Participants who were deemed eligible for re-treatment.
[2]
Completed=Completed Repeat Treatment Follow-up
Arm/Group Title VOLUMA® XC Treatment Arm Control Arm_No Treatment Then VOLUMA® XC Total
Hide Arm/Group Description Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable. No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable. Total of all reporting groups
Overall Number of Baseline Participants 235 47 282
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 235 participants 47 participants 282 participants
54.4  (7.18) 54.7  (5.95) 54.4  (6.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants 47 participants 282 participants
Female
189
  80.4%
37
  78.7%
226
  80.1%
Male
46
  19.6%
10
  21.3%
56
  19.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 235 participants 47 participants 282 participants
United States 208 41 249
Canada 27 6 33
1.Primary Outcome
Title Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)
Hide Description The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to treatment who received treatment and all participants randomized to "no treatment" control arm, with data available for analysis.
Arm/Group Title VOLUMA® XC Treatment Arm Control Arm_No Treatment Then VOLUMA® XC
Hide Arm/Group Description:
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
Overall Number of Participants Analyzed 209 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
85.6 [1] 
(NA to NA)
38.9 [2] 
(NA to NA)
[1]
Only a 97.5% Confidence Interval was calculated = 79.33% to 90.64%.
[2]
Only a 97.5% Confidence Interval was calculated = 21.33% to 58.82%.
2.Secondary Outcome
Title Duration of Treatment Effect
Hide Description Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators’ assessments (with 95% Greenwood's Confidence Interval).
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to the treatment arm who received treatment and all participants randomized to "no treatment" control arm who received treatment, with data available for analysis.
Arm/Group Title VOLUMA® XC Treatment Arm Control Arm_No Treatment Then VOLUMA® XC
Hide Arm/Group Description:
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
Overall Number of Participants Analyzed 235 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
44.6
(37.31 to 51.87)
44.9
(27.76 to 62.14)
3.Secondary Outcome
Title Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)
Hide Description The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.
Arm/Group Title VOLUMA® XC Treatment Arm
Hide Arm/Group Description:
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
Overall Number of Participants Analyzed 209
Measure Type: Number
Unit of Measure: Percentage of responders
81.8
4.Secondary Outcome
Title Responder Rate Based on Improvement in Score on MFVDS by Facial Region
Hide Description The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s respective mid-facial area score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. The percentage of responders is categorized by facial region.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.
Arm/Group Title VOLUMA® XC Treatment Arm
Hide Arm/Group Description:
Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
Overall Number of Participants Analyzed 209
Measure Type: Number
Unit of Measure: percentage of responders
Zygomaticomalar Region 75.6
Anteromedial Cheek 83.3
Submalar Region 77.0
Time Frame 30 days after repeat treatment (Up to 28 months)
Adverse Event Reporting Description Only device- or procedure-related Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at >5% frequency are reported. More than 1 event can occur in 1 participant.
 
Arm/Group Title All Treated Participants_ AEs Initial Treatment All Treated Participants_ AEs After Repeat Treatment
Hide Arm/Group Description All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment. All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment.
All-Cause Mortality
All Treated Participants_ AEs Initial Treatment All Treated Participants_ AEs After Repeat Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Treated Participants_ AEs Initial Treatment All Treated Participants_ AEs After Repeat Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/270 (4.07%)      2/167 (1.20%)    
Eye disorders     
Optic ischaemic neuropathy  2  1/270 (0.37%)  0/167 (0.00%) 
Optic neuropathy  2  1/270 (0.37%)  0/167 (0.00%) 
General disorders     
Inflammation  1  1/270 (0.37%)  0/167 (0.00%) 
Injection site mass  2  1/270 (0.37%)  0/167 (0.00%) 
Infections and infestations     
Appendicitis  2  1/270 (0.37%)  0/167 (0.00%) 
Injury, poisoning and procedural complications     
Humerus fracture  2  1/270 (0.37%)  0/167 (0.00%) 
Hip fracture  2  0/270 (0.00%)  1/167 (0.60%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  2  2/270 (0.74%)  0/167 (0.00%) 
Carcinoid tumour pulmonary  2  1/270 (0.37%)  0/167 (0.00%) 
Squamous cell carcinoma of skin  2  1/270 (0.37%)  0/167 (0.00%) 
Thyroid cancer  2  1/270 (0.37%)  0/167 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  2  1/270 (0.37%)  1 1/167 (0.60%)  1
Skin and subcutaneous tissue disorders     
Skin mass  2  1/270 (0.37%)  0/167 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
2
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Treated Participants_ AEs Initial Treatment All Treated Participants_ AEs After Repeat Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/270 (36.30%)      15/167 (8.98%)    
General disorders     
Injection site mass  1 [1]  54/270 (20.00%)  8/167 (4.79%) 
Injection site induration  2 [1]  39/270 (14.44%)  7/167 (4.19%) 
Injection site swelling  2 [1]  21/270 (7.78%)  1/167 (0.60%) 
Injection site pain  2 [1]  17/270 (6.30%)  1/167 (0.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
2
Term from vocabulary, MedDRA 15.1
[1]
Administration site condition
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.
As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00978042     History of Changes
Other Study ID Numbers: VOLUMA-002
First Submitted: September 15, 2009
First Posted: September 16, 2009
Results First Submitted: November 22, 2013
Results First Posted: February 13, 2014
Last Update Posted: November 3, 2015