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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment, needle | Experimental |
| |
| Treatment, cannula | Experimental |
| |
| Untreated-control / delayed-treatment, needle | Other |
| |
| Untreated-control / delayed-treatment, cannula | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belotero Balance (+) Lidocaine, needle | Device | Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8 | Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysis was done using multiple imputation method to impute missing MIHAS scores. Percentage of subjects with response at Week 8 and corresponding confidence intervals were average values obtained from the multiple imputation approach. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator | The GAIS is a 7-point scale ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved. |
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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 |
|---|---|---|---|---|---|---|
| Art of Skin MD, Merz Investigational Site #0010444 | Solana Beach | California | 92075 | United States | ||
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Of the 187 screened subjects, 37 were exited as screen failures.150 subjects were enrolled and randomized in this study.
Subjects were recruited from 9 investigational sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Belotero Balance (+) Lidocaine (BBL) Treatment With Needle | Subjects received a single treatment of BBL injection using needle in both infraorbital hollow (IOH) areas at Day 1 and 48 weeks after last injection (optional retreatment). Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2021 | Oct 25, 2023 |
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| Belotero Balance (+) Lidocaine, cannula | Device | Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas |
|
| Untreated-control / delayed-treatment, needle | Device | Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles) |
|
| Untreated-control / delayed-treatment, cannulas | Device | Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas) |
|
| Week 8 |
| Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject | The GAIS is a 7-point scale ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the subject. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved. | Week 8 |
| Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8 | The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. Subjects answered 7 questions of the FACE-Q satisfaction with eyes using a 4- point scale where: 1(very dissatisfied), 2 (somewhat dissatisfied), 3 (somewhat satisfied), 4 (very satisfied). The sum FACE-Q scores were Rasch-transformed and ranged from 0 to 100. Higher scores reflected a better outcome (greater satisfaction). | Baseline, Week 8 |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL | TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. A TEAE was considered to be "related" if a causal relationship between BBL and the TEAE is at least reasonably possible. | BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks |
| Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL | TESAEs included TEAEs that resulted in death, required either inpatient hospitalization or the prolongation of hospitalization, were life-threatening, resulted in a persistent or significant disability/incapacity or resulted in a congenital anomaly/birth defect. A TESAE was considered to be "related" if a causal relationship between BBL and the TESAE is at least reasonably possible. | BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks |
| Moradi MD Face Beautiful Inc., Merz Investigational Site #0010358 |
| Vista |
| California |
| 92083 |
| United States |
| MetroDerm / Atlanta Center for Clinical Research, Merz Investigational Site #0010446 | Atlanta | Georgia | 30342 | United States |
| Project Glammers, Merz Investigational Site #0010443 | Brooklyn | New York | 11229 | United States |
| The Center for Dermatology, Cosmetic & Laser Surgery, Merz Investigational Site #0010442 | Mount Kisco | New York | 10549 | United States |
| Mariwalla Dermatology, Merz Investigational Site #0010445 | West Islip | New York | 11795 | United States |
| HKB Surgeons, Merz Investigational Site #0010447 | Huntersville | North Carolina | 28078 | United States |
| Nashville Centre for Laser & Facial Surgery, Merz Investigational Site #0010353 | Nashville | Tennessee | 37203 | United States |
| Jose Raul Montes Eyes and Facial Rejuvenation, Merz Investigational Site #0010436 | San Juan | 00917 | Puerto Rico |
| BBL Treatment With Cannula |
Subjects received a single treatment of BBL injection using cannula in both IOH areas at Day 1 and 48 weeks after last injection (optional retreatment). Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| FG002 | Control/Delayed-treatment BBL With Needle | Subjects were untreated until Week 8 and then received a single treatment of BBL injection using needle in both IOH areas. Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| FG003 | Control/Delayed-treatment BBL With Cannula | Subjects were untreated until Week 8 and then received a single treatment of BBL injection using cannula in both IOH areas. Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent-to-treat (ITT) population included all randomized and treated subjects of the treatment group as well as all randomized subjects of the control/delayed-treatment groups.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BBL Treatment With Needle | Subjects received a single treatment of BBL injection using needle in both IOH areas at Day 1 and 48 weeks after last injection (optional retreatment). Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| BG001 | BBL Treatment With Cannula | Subjects received a single treatment of BBL injection using cannula in both IOH areas at Day 1 and 48 weeks after last injection (optional retreatment). Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| BG002 | Control/Delayed-treatment BBL With Needle | Subjects were untreated until Week 8 and then received a single treatment of BBL injection using needle in both IOH areas. Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| BG003 | Control/Delayed-treatment BBL With Cannula | Subjects were untreated until Week 8 and then received a single treatment of BBL injection using cannula in both IOH areas. Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8 | Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysis was done using multiple imputation method to impute missing MIHAS scores. Percentage of subjects with response at Week 8 and corresponding confidence intervals were average values obtained from the multiple imputation approach. | ITT. As planned, the data for this outcome measure was analyzed for pooled BBL treatment groups (needle and cannula), BBL treatment with needle group, BBL treatment with cannula group and pooled control/delayed-treatment groups BBL (needle and cannula). | Posted | Number | 95% Confidence Interval | percentage of subjects | Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator | The GAIS is a 7-point scale ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved. | ITT. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure that is, subjects with observed data. As planned, the data for this outcome measure was calculated and analyzed only for subjects randomized to the treatment groups (needle and cannula). | Posted | Number | percentage of subjects | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject | The GAIS is a 7-point scale ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the subject. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved. | ITT. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure that is, subjects with observed data. As planned, the data for this outcome measure was calculated and analyzed only for subjects randomized to the treatment groups (needle and cannula). | Posted | Number | percentage of subjects | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8 | The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. Subjects answered 7 questions of the FACE-Q satisfaction with eyes using a 4- point scale where: 1(very dissatisfied), 2 (somewhat dissatisfied), 3 (somewhat satisfied), 4 (very satisfied). The sum FACE-Q scores were Rasch-transformed and ranged from 0 to 100. Higher scores reflected a better outcome (greater satisfaction). | ITT. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure that is, subjects with observed data. As planned, the data for this outcome measure was calculated and analyzed only for subjects randomized to the treatment groups (needle and cannula). | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL | TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. A TEAE was considered to be "related" if a causal relationship between BBL and the TEAE is at least reasonably possible. | The Safety Population (SP) included all treated subjects. | Posted | Count of Participants | Participants | No | BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL | TESAEs included TEAEs that resulted in death, required either inpatient hospitalization or the prolongation of hospitalization, were life-threatening, resulted in a persistent or significant disability/incapacity or resulted in a congenital anomaly/birth defect. A TESAE was considered to be "related" if a causal relationship between BBL and the TESAE is at least reasonably possible. | SP. | Posted | Count of Participants | Participants | No | BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks |
|
BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 8 weeks; Delayed-treatment BBL (Needle and Cannula): Up to 48 weeks
The investigator reported adverse events (AEs) systematically at each visit. The data for AEs was reported as per treatment received by the subject.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BBL Treatment With Needle | Subjects received a single treatment of BBL injection using needle in both IOH areas at Day 1 and 48 weeks after last injection (optional retreatment). Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. | 0 | 49 | 1 | 49 | 6 | 49 |
| EG001 | BBL Treatment With Cannula | Subjects received a single treatment of BBL injection using cannula in both IOH areas at Day 1 and 48 weeks after last injection (optional retreatment). Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. | 0 | 48 | 0 | 48 | 11 | 48 |
| EG002 | Control/Delayed-treatment BBL With Needle | Subjects randomized to Delayed-treatment BBL With Needle from randomization until initial treatment at Week 8. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG003 | Delayed-treatment BBL With Needle | Subjects received a single treatment of BBL injection using needle in both IOH areas at Week 8 and were eligible to receive an optional touch-up injection 4 weeks after initial injection. | 0 | 26 | 0 | 26 | 4 | 26 |
| EG004 | Control/Delayed-treatment BBL With Cannula | Subjects randomized to Delayed-treatment BBL With Cannula from randomization until initial treatment at Week 8. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG005 | Delayed-treatment BBL With Cannula | Subjects received a single treatment of BBL injection using cannula in both IOH areas at Week 8 and were eligible to receive an optional touch-up injection 4 weeks after initial injection. | 0 | 21 | 0 | 21 | 1 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Visual acuity tests abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
|
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 Aesthetics | +1 984-301-3095 | Aesthetic.Trials@merz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 22, 2022 | Oct 25, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009339 | Needles |
| D000072601 | Cannula |
| D000096182 | Treatment Delay |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D057785 | Catheters |
| D061665 | Time-to-Treatment |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Difference in response rates |
| 85.4 |
| 2-Sided |
| 95 |
| 70.5 |
| 92.3 |
| Superiority |
| Difference in response rates | 71.8 | 2-Sided | 95 | 55.2 | 82.5 | Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Subjects were untreated until Week 8 and then received a single treatment of BBL injection using needle in both IOH areas. Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection.
| OG003 | Control/Delayed-treatment BBL With Cannula | Subjects were untreated until Week 8 and then received a single treatment of BBL injection using cannula in both IOH areas. Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
|
|
Subjects were untreated until Week 8 and then received a single treatment of BBL injection using needle in both IOH areas. Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
| OG003 | Control/Delayed-treatment BBL With Cannula | Subjects were untreated until Week 8 and then received a single treatment of BBL injection using cannula in both IOH areas. Subjects were eligible to receive an optional touch-up injection 4 weeks after initial injection. |
|
|