Correction of Volume Loss in the Infraorbital Hollow Area
Conditions
Brief summary
The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.
Interventions
DEVICEBelotero Balance®
Belotero® Balance for infraorbital hollows. Mode of application: subdermal injection.
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has right and left infraorbital hollow (IOH) volume deficit with a rating of 2 or 3 (moderate or severe) on the MIHAS. * Has the same MIHAS score on both IOHs (i.e., IOHs are symmetrical). * Is at least 22 years of age.
Exclusion criteria
* Ever been treated with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region. * Received lower eyelid and/or malar region treatments with any absorbable or temporary fillers such as porcine-based collagen fillers, hyaluronic acid (HA) products, RADIESSE®, poly L-lactic acid (PLLA) or received mesotherapy treatment to the area within the past 24 months or plans to receive such treatments during participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS). | Baseline up to Month 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes | Baseline and Month 2 | 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. |
| Global Aesthetic Improvement Scale (GAIS) Scores | Baseline up to Month 2 | 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). |
| GAIS Scores as Assessed by Participants | Baseline up to Month 2 | 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). |
| Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers | Baseline up to Month 2 | 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. |
| 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 | Treatment Group: Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2 | — |
Countries
United States
Participant flow
Recruitment details
3 investigational sites in the United States.
Pre-assignment details
A total of 66 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Belotero Balance® Belotero Balance®, subcutaneous injection for IOHs. | 43 |
| Untreated Control Group No treatment. | 22 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 2 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Untreated Control Group | Total | Treatment With Belotero Balance® |
|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 11.6 | 46.4 years STANDARD_DEVIATION 12.2 | 45.9 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 58 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 55 Participants | 38 Participants |
| Sex: Female, Male Female | 18 Participants | 55 Participants | 37 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 22 |
| other Total, other adverse events | 0 / 43 | 0 / 22 |
| serious Total, serious adverse events | 1 / 43 | 0 / 22 |
Outcome results
Primary
Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS).
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.
Time frame: Baseline up to Month 2
Population: The intent-to-treat (ITT) population consisted of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Belotero Balance® | Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS). | 81.6 percentage of participants |
| Untreated Control Group | Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS). | 9.5 percentage of participants |
p-value: <0.000195% CI: [47.5, 83.5]Fisher Exact
Secondary
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes
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.
Time frame: Baseline and Month 2
Population: The ITT population consisted of all randomized participants. Here overall number of participants analyzed were participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment With Belotero Balance® | Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes | 28.8 score on a scale |
| Untreated Control Group | Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes | 2.1 score on a scale |
Secondary
GAIS Scores as Assessed by Participants
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).
Time frame: Baseline up to Month 2
Population: 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®.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Belotero Balance® | GAIS Scores as Assessed by Participants | Improved (+1) | 15 Participants |
| Treatment With Belotero Balance® | GAIS Scores as Assessed by Participants | Very Much Improved (+3) | 11 Participants |
| Treatment With Belotero Balance® | GAIS Scores as Assessed by Participants | Much Improved (+2) | 9 Participants |
| Treatment With Belotero Balance® | GAIS Scores as Assessed by Participants | No Change (0) | 2 Participants |
| Treatment With Belotero Balance® | GAIS Scores as Assessed by Participants | Worse (-1) | 1 Participants |
| Treatment With Belotero Balance® | GAIS Scores as Assessed by Participants | Much Worse (-2) | 0 Participants |
| Treatment With Belotero Balance® | GAIS Scores as Assessed by Participants | Very Much Worse (-3) | 0 Participants |
Secondary
Global Aesthetic Improvement Scale (GAIS) Scores
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).
Time frame: Baseline up to Month 2
Population: 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®.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Belotero Balance® | Global Aesthetic Improvement Scale (GAIS) Scores | Very Much Improved (+3) | 23 Participants |
| Treatment With Belotero Balance® | Global Aesthetic Improvement Scale (GAIS) Scores | Much Improved (+2) | 4 Participants |
| Treatment With Belotero Balance® | Global Aesthetic Improvement Scale (GAIS) Scores | Improved (+1) | 11 Participants |
| Treatment With Belotero Balance® | Global Aesthetic Improvement Scale (GAIS) Scores | No Change (0) | 0 Participants |
| Treatment With Belotero Balance® | Global Aesthetic Improvement Scale (GAIS) Scores | Worse (-1) | 0 Participants |
| Treatment With Belotero Balance® | Global Aesthetic Improvement Scale (GAIS) Scores | Much Worse (-2) | 0 Participants |
| Treatment With Belotero Balance® | Global Aesthetic Improvement Scale (GAIS) Scores | Very Much Worse (-3) | 0 Participants |
Secondary
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
Time frame: Treatment Group: Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Belotero Balance® | 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 |
| Treatment With Belotero Balance® | 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 |
| Untreated Control Group | 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 | 0 Participants |
| Untreated Control Group | 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 |
Secondary
Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers
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.
Time frame: Baseline up to Month 2
Population: The ITT population consisted of all randomized participants. Here overall number of participants analyzed were participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Belotero Balance® | 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 |
| Untreated Control Group | Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers | 9.5 percentage of participants |