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To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Radiesse (+) | Experimental |
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| Control/Delayed Treatment with Radiesse (+) | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiesse (+) | Device | Radiesse (+) for jawlines. |
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| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate According to the Merz Jawline Assessment Scale (MJAS) | MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (>=) 1-point improvement. | At Week 12 |
| 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 | Baseline up to end of study (Week 60) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Face-Q Satisfaction | The participant assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (Rasch transformed score 0-100; higher scores mean better outcome). | Baseline up to Week 12 |
| Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator |
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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 |
|---|---|---|---|---|---|---|
| Clinical Testing of Beverly Hills, Merz Investigational Site #0010395 | Beverly Hills | California | 90210 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34784131 | Background | Moradi A, Green J, Cohen J, Joseph J, Dakovic R, Odena G, Verma A, Scher R. Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour. J Drugs Dermatol. 2021 Nov 1;20(11):1231-1238. doi: 10.36849/jdd.6442. | |
| 39505354 | Derived | Moradi A, Dakovic R. Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour. J Dermatolog Treat. 2024 Dec;35(1):2421435. doi: 10.1080/09546634.2024.2421435. Epub 2024 Nov 6. |
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A total of 180 participants were enrolled and randomized in the study.
15 investigational sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Radiesse (+) | Right and left jawline injected with Radiesse (+). |
| FG001 | Control/Delayed Treatment With Radiesse (+) | Participants did not receive treatment for the first 12 weeks. |
| 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 | May 2, 2022 | May 3, 2022 |
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GAIS ratings (-3 to +3 scores; lower scores mean worse outcome). |
| At Week 12 |
| GAIS Scores as Assessed by Participants | GAIS ratings (-3 to +3 scores; lower scores mean worse outcome). | At Week 12 |
| Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs) | MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a >=1-point improvement. | At Week 12 |
| Skin Care Center, Merz Investigational Site #0010099 |
| Los Angeles |
| California |
| 90069 |
| United States |
| Ava MD, Merz Investigational Site #0010299 | Santa Monica | California | 90404 | United States |
| Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358 | Vista | California | 92083 | United States |
| AboutSkin Research LLC, Merz Investigational Site #0010103 | Greenwood Village | Colorado | 80111 | United States |
| Skin Research Institute, Merz Investigational Site #0010101 | Coral Gables | Florida | 33146 | United States |
| Research Institute of the Southeast, LLC, Merz Investigational Site #0010420 | West Palm Beach | Florida | 33401 | United States |
| Lupo Center for Aesthetic and General Dermatology, Merz Investigational Site #0010418 | New Orleans | Louisiana | 70124 | United States |
| MD Laser Skin & Vein Institute, Merz Investigational Site #0010323 | Hunt Valley | Maryland | 21030 | United States |
| SkinCare Physicians of Chestnut Hill. Merz Investigational #0010098 | Chestnut Hill | Massachusetts | 02467 | United States |
| Skinfluence Medical PC, Merz Investigational #0010421 | New York | New York | 10028 | United States |
| Bass Plastic Surgery PLLC, Merz Investigational Site #0010419 | New York | New York | 10065 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas, Merz Investigational Site #0010194 | Charlotte | North Carolina | 28207 | United States |
| Clinical Research Center of the Carolinas, Merz Investigational Site #0010417 | Charleston | South Carolina | 29407 | United States |
| Westlake Dermatology, Merz Investigational Site #0010322 | Austin | Texas | 78746 | United States |
| 38934231 | Derived | Green JB, Del Campo R, Durkin AJ, Funt DK, Nasrallah N, Martinez K, Moradi A. Long-term duration and safety of Radiesse (+) for the treatment of jawline. J Cosmet Dermatol. 2024 Oct;23(10):3202-3209. doi: 10.1111/jocd.16436. Epub 2024 Jun 27. |
| Treated Participants |
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| COMPLETED |
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| NOT COMPLETED |
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The Intent-to-Treat (ITT) population consisted of all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Radiesse (+) | Right and left jawline injected with Radiesse (+). |
| BG001 | Control/Delayed Treatment With Radiesse (+) | Participants did not receive treatment for the first 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 According to the Merz Jawline Assessment Scale (MJAS) | MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (>=) 1-point improvement. | ITT population consisted of all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 12 |
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| Primary | 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 safety evaluation set (SES) was the subset of all participants who were exposed to study medication at least once. | Posted | Count of Participants | Participants | Baseline up to end of study (Week 60) |
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| Secondary | Percent Change From Baseline in Face-Q Satisfaction | The participant assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (Rasch transformed score 0-100; higher scores mean better outcome). | 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 | percent change | Baseline up to Week 12 |
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| Secondary | Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator | GAIS ratings (-3 to +3 scores; lower scores mean worse outcome). | 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 in treatment with Radiesse (+) group. | Posted | Count of Participants | Participants | At Week 12 |
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| Secondary | GAIS Scores as Assessed by Participants | GAIS ratings (-3 to +3 scores; lower scores mean worse outcome). | 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 in treatment with Radiesse (+) group. | Posted | Count of Participants | Participants | At Week 12 |
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| Secondary | Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs) | MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a >=1-point improvement. | ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 12 |
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From first treatment up to the end of study (Week 60)
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 Radiesse (+) | Right and left jawline injected with Radiesse (+). | 0 | 122 | 1 | 122 | 25 | 122 |
| EG001 | Control/Delayed Treatment With Radiesse (+) | Participants did not receive treatment for the first 12 weeks. | 0 | 53 | 2 | 53 | 7 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site mass | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 20.1 | 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 | May 2, 2022 | May 3, 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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