Trial Outcomes & Findings for A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow (NCT NCT03777917)
NCT ID: NCT03777917
Last Updated: 2023-11-14
Results Overview
MIHAS was a 5 point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved greater than or equal to (\>=) 1 grade improvement on both IOHs on the MIHAS.
COMPLETED
NA
66 participants
Baseline up to Month 2
2023-11-14
Participant Flow
3 investigational sites in the United States.
A total of 66 participants were randomized.
Participant milestones
| Measure |
Treatment With Belotero Balance®
IOH injected with Belotero Balance®.
|
Untreated Control Group
No treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
23
|
|
Overall Study
Safety Population
|
43
|
22
|
|
Overall Study
COMPLETED
|
34
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
Treatment With Belotero Balance®
IOH injected with Belotero Balance®.
|
Untreated Control Group
No treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
Baseline characteristics by cohort
| Measure |
Treatment With Belotero Balance®
n=43 Participants
Belotero Balance®, subcutaneous injection for IOHs.
|
Untreated Control Group
n=22 Participants
No treatment.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 2Population: The intent-to-treat (ITT) population consisted of all randomized participants.
MIHAS was a 5 point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved greater than or equal to (\>=) 1 grade improvement on both IOHs on the MIHAS.
Outcome measures
| Measure |
Treatment With Belotero Balance®
n=38 Participants
Belotero Balance®, subcutaneous injection for IOHs.
|
Untreated Control Group
n=21 Participants
No treatment.
|
|---|---|---|
|
Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS).
|
81.6 percentage of participants
|
9.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 2Population: The ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
The FACE-Q is a set of standardized patient-reported outcome scales for participants undergoing facial cosmetic procedures. The participants answered 7 questions of the FACE-Q satisfaction with eyes scale using a 4 point scale where: 1 (very dissatisfied), 2 (somewhat dissatisfied), 3 (somewhat satisfied), 4 (very satisfied). The sum scores of the FACE-Q satisfaction with eyes questionnaire and the Rasch-transformed scores ranging from 0 to 100 were summarized by treatment arm. Higher scores reflected a better outcome.
Outcome measures
| Measure |
Treatment With Belotero Balance®
n=38 Participants
Belotero Balance®, subcutaneous injection for IOHs.
|
Untreated Control Group
n=21 Participants
No treatment.
|
|---|---|---|
|
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes
|
28.8 score on a scale
Interval 21.2 to 36.5
|
2.1 score on a scale
Interval -3.9 to 8.1
|
SECONDARY outcome
Timeframe: Baseline up to Month 2Population: The ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. As planned, this OM was evaluated only for participants treated with Belotero Balance®.
7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse).
Outcome measures
| Measure |
Treatment With Belotero Balance®
n=38 Participants
Belotero Balance®, subcutaneous injection for IOHs.
|
Untreated Control Group
No treatment.
|
|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Scores
Improved (+1)
|
11 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores
No Change (0)
|
0 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores
Worse (-1)
|
0 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores
Much Worse (-2)
|
0 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores
Very Much Worse (-3)
|
0 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores
Very Much Improved (+3)
|
23 Participants
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Scores
Much Improved (+2)
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 2Population: The ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. As planned, this OM was evaluated only for participants treated with Belotero Balance®.
Participants evaluated their IOHs on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse).
Outcome measures
| Measure |
Treatment With Belotero Balance®
n=38 Participants
Belotero Balance®, subcutaneous injection for IOHs.
|
Untreated Control Group
No treatment.
|
|---|---|---|
|
GAIS Scores as Assessed by Participants
Very Much Worse (-3)
|
0 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Very Much Improved (+3)
|
11 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Much Improved (+2)
|
9 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Improved (+1)
|
15 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
No Change (0)
|
2 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Worse (-1)
|
1 Participants
|
—
|
|
GAIS Scores as Assessed by Participants
Much Worse (-2)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 2Population: The ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
MIHAS was a 5 point scale ranging as: 0 (none to minimal), 1 (mild), 2 (moderate), 3 (severe), 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved \>=1 improvement on both IOHs compared to baseline. A participant was considered a responder if a treatment response of at least a 1-point change on both IOHs was determined by independent panel reviewers.
Outcome measures
| Measure |
Treatment With Belotero Balance®
n=38 Participants
Belotero Balance®, subcutaneous injection for IOHs.
|
Untreated Control Group
n=21 Participants
No treatment.
|
|---|---|---|
|
Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers
|
36.8 percentage of participants
|
9.5 percentage of participants
|
SECONDARY outcome
Timeframe: Treatment Group: Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2Population: The SP consisted of all randomized participants who received at least one study treatment in the active treatment group or who were randomized into the control arm.
Outcome measures
| Measure |
Treatment With Belotero Balance®
n=43 Participants
Belotero Balance®, subcutaneous injection for IOHs.
|
Untreated Control Group
n=22 Participants
No treatment.
|
|---|---|---|
|
Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs
TEAEs
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment With Belotero Balance®
Untreated Control Group
Serious adverse events
| Measure |
Treatment With Belotero Balance®
n=43 participants at risk
Belotero Balance®, subcutaneous injection for IOHs.
|
Untreated Control Group
n=22 participants at risk
No treatment.
|
|---|---|---|
|
Eye disorders
Retinal detachment
|
2.3%
1/43 • Treatment Group : Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2
The investigator reported AEs systematically at each visit.
|
0.00%
0/22 • Treatment Group : Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2
The investigator reported AEs systematically at each visit.
|
|
Eye disorders
Vitreous detachment
|
2.3%
1/43 • Treatment Group : Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2
The investigator reported AEs systematically at each visit.
|
0.00%
0/22 • Treatment Group : Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2
The investigator reported AEs systematically at each visit.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER