An interventional study of Treatment with diluted Radiesse in Décolleté Wrinkles, sponsored by Merz North America, Inc.. Completed at 9 sites in United States. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by Merz North America, Inc. (part of Merz Pharma) · Not applicable, Interventional, and Treatment
Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.
Merz North America, Inc. is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 19 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Injection of Décolleté Wrinkles with diluted Radiesse
Device: Treatment with diluted Radiesse
Delayed injection of Décolleté Wrinkles with diluted Radiesse
Device: Treatment with diluted Radiesse
Injection of Décolleté Wrinkles with diluted Radiesse
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.
Time frame: Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Subjects were recruited from 9 investigational sites in the United States.
| Milestone | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse |
|---|---|---|
| Started | 116 | 36 |
| Intent to treat (itt) set | 116 | 36 |
| Safety evaluation set (ses) | 107 | 30 |
| Completed | 81 | 27 |
| Not completed | 35 | 9 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 21 | 6 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Lost to follow-up | 13 | 2 |
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.
| percentage of subjects | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse |
|---|---|---|
| Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 | 71.2 (61.4 to 79.4) | 6.3 (1.5 to 22.9) |
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.
| percentage of subjects | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse |
|---|---|---|
| Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24 | 65.8 (55.9 to 74.5) | 16.0 (6.8 to 33.1) |
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.
| percentage of subjects | Treatment With Radiesse |
|---|---|
| Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24 | 92.6 |
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.
| percentage of subjects | Treatment With Radiesse |
|---|---|
| Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24 | 87.4 |
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).
| Participants | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse |
|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse | 16 | 0 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Radiesse | 0/116 (0%) | 2/116 (1.7%) | 17/116 (14.7%) |
| Untreated Control/Delayed Treatment With Radiesse | 0/36 (0%) | 0/36 (0%) | 2/36 (5.6%) |
| Event | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse |
|---|---|---|
| Condition aggravatedGeneral disorders | 1/116 | 0/36 |
| Animal biteInjury, poisoning and procedural complications | 1/116 | 0/36 |
| Hip deformityMusculoskeletal and connective tissue disorders | 1/116 | 0/36 |
| Event | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse |
|---|---|---|
| Visual acuity tests abnormalInvestigations | 9/116 | 0/36 |
| Injection site bruisingGeneral disorders | 7/116 | 0/36 |
| COVID-19Infections and infestations | 3/116 | 2/36 |
ITT Analysis Set.
| Age, Continuous(years) | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse | Total |
|---|---|---|---|
| Mean | 53.7 ± 7.05 | 53.6 ± 8.08 | 53.6 ± 7.28 |
| Sex: Female, Male(Participants) | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse | Total |
|---|---|---|---|
| Female | 116 | 36 | 152 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse | Total |
|---|---|---|---|
| Hispanic or Latino | 18 | 7 | 25 |
| Not Hispanic or Latino | 98 | 29 | 127 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment With Radiesse | Untreated Control/Delayed Treatment With Radiesse | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 1 | 6 |
| White | 105 | 35 | 140 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2021 to primary completion in Sep 2022, 9 months.
Results were first posted in Oct 2025, 3 years after primary completion. A results delay was requested in Sep 2023.
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