Trial Outcomes & Findings for JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines (NCT NCT01970397)
NCT ID: NCT01970397
Last Updated: 2019-04-16
Results Overview
The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
JUVEDERM® Ultra XC
JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
Belotero Balance®
Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
69
|
|
Overall Study
COMPLETED
|
67
|
64
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
JUVEDERM® Ultra XC
JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
Belotero Balance®
Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Personal Reasons
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines
Baseline characteristics by cohort
| Measure |
JUVEDERM® Ultra XC
n=68 Participants
JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
Belotero Balance®
n=68 Participants
Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 9.26 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Participants from the Intent-to-treat population, all randomized treated participants, with data available for analysis at Month 6.
The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.
Outcome measures
| Measure |
JUVEDERM® Ultra XC
n=67 Participants
JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
Belotero Balance®
n=65 Participants
Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
|---|---|---|
|
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
|
87 percentage of participants
|
72 percentage of participants
|
SECONDARY outcome
Timeframe: During injection, immediately following injection, 15, 30, and 45 min post-injectionPopulation: Intent-to-treat population included all randomized and treated participants.
The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.
Outcome measures
| Measure |
JUVEDERM® Ultra XC
n=68 Participants
JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
Belotero Balance®
n=68 Participants
Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
|---|---|---|
|
Participant Assessed Procedural and Post-Procedural Pain Levels
During Injection
|
2.9 units on a scale
Interval 2.4 to 3.5
|
4.4 units on a scale
Interval 3.8 to 5.0
|
|
Participant Assessed Procedural and Post-Procedural Pain Levels
Immediately following Injection
|
0.8 units on a scale
Interval 0.5 to 1.1
|
1.8 units on a scale
Interval 1.4 to 2.3
|
|
Participant Assessed Procedural and Post-Procedural Pain Levels
30 minutes following Injection
|
0.1 units on a scale
Interval 0.0 to 0.2
|
0.3 units on a scale
Interval 0.1 to 0.4
|
|
Participant Assessed Procedural and Post-Procedural Pain Levels
45 minutes following Injection
|
0.0 units on a scale
Interval 0.0 to 0.1
|
0.2 units on a scale
Interval 0.1 to 0.3
|
|
Participant Assessed Procedural and Post-Procedural Pain Levels
15 minutes following Injection
|
0.1 units on a scale
Interval 0.0 to 0.3
|
0.5 units on a scale
Interval 0.3 to 0.7
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6Population: Participants from the Intent-to-treat population, all randomized treated participants, with data available at the given time-point.
The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.
Outcome measures
| Measure |
JUVEDERM® Ultra XC
n=68 Participants
JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
Belotero Balance®
n=68 Participants
Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
|---|---|---|
|
Subject's Global Assessment of Change in Appearance of Perioral Lines
Day 7 after Touch-up (n=30,42)
|
1.6 units on a scale
Interval 1.4 to 1.8
|
1.8 units on a scale
Interval 1.6 to 2.0
|
|
Subject's Global Assessment of Change in Appearance of Perioral Lines
Day 14 after Touch-up (n=32,40)
|
1.8 units on a scale
Interval 1.5 to 2.0
|
1.8 units on a scale
Interval 1.6 to 2.0
|
|
Subject's Global Assessment of Change in Appearance of Perioral Lines
Month 1 (n=66,67)
|
1.7 units on a scale
Interval 1.5 to 1.9
|
2.0 units on a scale
Interval 1.8 to 2.1
|
|
Subject's Global Assessment of Change in Appearance of Perioral Lines
Month 3 (n=68,65)
|
1.8 units on a scale
Interval 1.7 to 2.0
|
2.2 units on a scale
Interval 2.0 to 2.4
|
|
Subject's Global Assessment of Change in Appearance of Perioral Lines
Month 6 (n=67,65)
|
1.9 units on a scale
Interval 1.7 to 2.1
|
2.6 units on a scale
Interval 2.3 to 2.8
|
|
Subject's Global Assessment of Change in Appearance of Perioral Lines
Day 7
|
1.8 units on a scale
Interval 1.7 to 2.0
|
2.1 units on a scale
Interval 1.9 to 2.2
|
|
Subject's Global Assessment of Change in Appearance of Perioral Lines
Day 14 or Touch-up (n=66,67)
|
1.7 units on a scale
Interval 1.5 to 1.9
|
2.0 units on a scale
Interval 1.8 to 2.2
|
Adverse Events
JUVEDERM® Ultra XC
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Belotero Balance®
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
JUVEDERM® Ultra XC
n=68 participants at risk
JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
Belotero Balance®
n=68 participants at risk
Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
|
|---|---|---|
|
General disorders
Injection site bruise
|
7.4%
5/68
Safety population, all randomized treated participants, was used to determine the number of participants at risk for Serious and Non-serious adverse events.
|
13.2%
9/68
Safety population, all randomized treated participants, was used to determine the number of participants at risk for Serious and Non-serious adverse events.
|
|
General disorders
Injection site induration
|
5.9%
4/68
Safety population, all randomized treated participants, was used to determine the number of participants at risk for Serious and Non-serious adverse events.
|
1.5%
1/68
Safety population, all randomized treated participants, was used to determine the number of participants at risk for Serious and Non-serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER