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The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belotero Balance® | Experimental |
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| No treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belotero Balance® | Device | Belotero® Balance for infraorbital hollows. Mode of application: subdermal injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Sight, Merz Investigational Site #0010414 | Sarasota | Florida | 34239 | United States | ||
| Private Practice, Merz Investigational Site #0010413 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36607759 | Background | Biesman B, Verma A, Cheng N, Duncan A. Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollowing. J Drugs Dermatol. 2023 Jan 1;22(1):74-81. doi: 10.36849/JDD.7191. |
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A total of 66 participants were randomized.
3 investigational sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Belotero Balance® | IOH injected with Belotero Balance®. |
| FG001 | Untreated Control Group | No treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2022 | Mar 21, 2022 |
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| Baseline and Month 2 |
| 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). | Baseline up to Month 2 |
| 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). | Baseline up to Month 2 |
| 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. | Baseline up to Month 2 |
| 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 |
| New York |
| New York |
| 10021 |
| United States |
| Center for Laser and Facial Surgery, Merz Investigational Site #0010353 | Nashville | Tennessee | 37203 | United States |
| Safety Population | 1 participant randomized into treatment group did not receive any treatment and was excluded from the safety population, and 1 participant randomized into the untreated group received Belotero Balance®. |
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The safety population (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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Belotero Balance® | Belotero Balance®, subcutaneous injection for IOHs. |
| BG001 | Untreated Control Group | No treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | The intent-to-treat (ITT) population consisted of all randomized participants. | Posted | Number | percentage of participants | Baseline up to Month 2 |
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| 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. | The ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Month 2 |
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| 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). | 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®. | Posted | Count of Participants | Participants | Baseline up to Month 2 |
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| 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). | 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®. | Posted | Count of Participants | Participants | Baseline up to Month 2 |
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| 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. | The ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to Month 2 |
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| 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 | 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. | Posted | Count of Participants | Participants | Treatment Group: Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2 |
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Treatment Group : Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2
The investigator reported AEs systematically at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Belotero Balance® | Belotero Balance®, subcutaneous injection for IOHs. | 0 | 43 | 1 | 43 | 0 | 43 |
| EG001 | Untreated Control Group | No treatment. | 0 | 22 | 0 | 22 | 0 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA 22.1 | Systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA 22.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | Aesthetic.Trials@merz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2022 | Mar 21, 2022 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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