Décolleté Wrinkles
Conditions
Brief summary
Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.
Interventions
DEVICETreatment with diluted Radiesse
Injection of Décolleté Wrinkles with diluted Radiesse
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female between ≥ 30 and ≤ 65 years old at the time of the screening. * Subjects seeking improvement of décolleté wrinkles.
Exclusion criteria
* Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area. * Previous treatment with collagen fillers, calcium hydroxylapatite, and/or long-lasting hyaluronic acid (HA) fillers in the décolleté, or with other HA fillers in the décolleté. * Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels, and/or non-invasive skin tightening in the décolleté.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24 | 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. |
| Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24 | 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. |
| Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24 | 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. |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse | 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) | 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). |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 9 investigational sites in the United States.
Pre-assignment details
A total of 152 subjects were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 116 |
| 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. | 36 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 13 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 21 | 6 |
Baseline characteristics
| Characteristic | Untreated Control/Delayed Treatment With Radiesse | Total | Treatment With Radiesse |
|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 8.08 | 53.6 years STANDARD_DEVIATION 7.28 | 53.7 years STANDARD_DEVIATION 7.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 25 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 127 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 140 Participants | 105 Participants |
| Sex: Female, Male Female | 36 Participants | 152 Participants | 116 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 36 |
| other Total, other adverse events | 17 / 116 | 2 / 36 |
| serious Total, serious adverse events | 2 / 116 | 0 / 36 |
Outcome results
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.
Time frame: Week 24
Population: ITT Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Radiesse | Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 | 71.2 percentage of subjects |
| Untreated Control/Delayed Treatment With Radiesse | Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 | 6.3 percentage of subjects |
95% CI: [45.6, 74.4]
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).
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)
Population: SES included all subjects treated at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Radiesse | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse | 16 Participants |
| Untreated Control/Delayed Treatment With Radiesse | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse | 0 Participants |
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.
Time frame: Week 24
Population: ITT Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Radiesse | Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24 | 65.8 percentage of subjects |
| Untreated Control/Delayed Treatment With Radiesse | Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24 | 16.0 percentage of subjects |
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Radiesse | Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24 | 92.6 percentage of subjects |
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Radiesse | Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24 | 87.4 percentage of subjects |