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Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with diluted Radiesse | Experimental | Injection of Décolleté Wrinkles with diluted Radiesse |
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| Delayed treatment with diluted Radiesse | Other | Delayed injection of Décolleté Wrinkles with diluted Radiesse |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with diluted Radiesse | Device | Injection of Décolleté Wrinkles with diluted Radiesse |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 | The percentage of responders (responder rate) was defined as the percentage of subjects achieving greater than or equal to (>=) 1-point improvement on MAS décolleté wrinkles-at Rest from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-at rest scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24 | The percentage of responders (responder rate) was defined as the percentage of subjects achieving >= 1-point improvement on MAS décolleté wrinkles-Dynamic from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-Dynamic scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Testing of Beverly Hills, Merz Investigational Site #0010395 | Beverly Hills | California | 90210 | United States | ||
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A total of 152 subjects were enrolled and randomized in the study.
Subjects were recruited from 9 investigational sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Radiesse | Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36. |
| FG001 | Untreated Control/Delayed Treatment With Radiesse |
| 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 10, 2022 | Jul 2, 2025 |
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| Week 24 |
| Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24 | Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS, where - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement. | Week 24 |
| Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24 | Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Subjects used the sGAIS, where - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement. | Week 24 |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse | TEAEs are defined as AEs with onset on or after date of first administration of study treatment. Treatment related TEAEs are defined as any TEAEs related to diluted Radiesse treatment (that is, related to either injection procedure and/or device). | From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) |
| Facial Plastic Surgery, Merz Investigational Site #0010463 |
| Redondo Beach |
| California |
| 90277 |
| United States |
| Cosmetic Laser Dermatology, Merz Investigational Site #0010321 | San Diego | California | 92121 | United States |
| Private Practice, Merz Investigational Site #0010299 | Santa Monica | California | 90404 | United States |
| Face Beautiful Inc, Merz Investigational Site #0010358 | Vista | California | 92083 | United States |
| Skin Associates of South Florida, 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 |
| The Graivier Center, Merz Investigational Site #0010464 | Alpharetta | Georgia | 30005 | United States |
| Nashville Center for Laser and Facial Surgery, Merz Investigational Site #0010353 | Nashville | Tennessee | 37203 | United States |
Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment. |
| Intent to Treat (ITT) Set | ITT population included all randomized subjects. |
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| Safety Evaluation Set (SES) | 9 subjects randomized in "Treatment With Radiesse" group and 6 subjects randomized in "Untreated Control/Delayed Treatment With Radiesse" group did not receive any treatment and were excluded from the safety population. |
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| NOT COMPLETED |
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ITT Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Radiesse | Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36. |
| BG001 | Untreated Control/Delayed Treatment With Radiesse | Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment. |
| 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 | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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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 | Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 | The percentage of responders (responder rate) was defined as the percentage of subjects achieving greater than or equal to (>=) 1-point improvement on MAS décolleté wrinkles-at Rest from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-at rest scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values. | ITT Analysis Set. | Posted | Number | 95% Confidence Interval | percentage of subjects | Week 24 |
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| Secondary | Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24 | The percentage of responders (responder rate) was defined as the percentage of subjects achieving >= 1-point improvement on MAS décolleté wrinkles-Dynamic from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-Dynamic scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values. | ITT Analysis Set. | Posted | Number | 95% Confidence Interval | percentage of subjects | Week 24 |
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| Secondary | Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24 | Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS, where - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement. | ITT Analysis Set. Here "overall number of subjects analyzed" were the number of subjects with data available for analysis of this outcome measure at the given time point. This outcome measure was pre-specified and analyzed for subjects receiving Radiesse treatment only. | Posted | Number | percentage of subjects | Week 24 |
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| Secondary | Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24 | Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Subjects used the sGAIS, where - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement. | ITT Analysis Set. Here "overall number of subjects analyzed" were the number of subjects with data available for analysis of this outcome measure at the given time point. This outcome measure was pre-specified and analyzed for subjects receiving Radiesse treatment only. | Posted | Number | percentage of subjects | Week 24 |
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| Secondary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse | TEAEs are defined as AEs with onset on or after date of first administration of study treatment. Treatment related TEAEs are defined as any TEAEs related to diluted Radiesse treatment (that is, related to either injection procedure and/or device). | SES included all subjects treated at least once. | Posted | Count of Participants | Participants | No | From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) |
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From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84)
ITT Analysis set. 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 | Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36. | 0 | 116 | 2 | 116 | 17 | 116 |
| EG001 | Untreated Control/Delayed Treatment With Radiesse | Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment. | 0 | 36 | 0 | 36 | 2 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Condition aggravated | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Hip deformity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity tests abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.0 | 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 Aesthetics | +1 984-301-3095 | Aesthetic.Trials@merz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2023 | Jul 2, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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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