Trial Outcomes & Findings for Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation (NCT NCT01004107)
NCT ID: NCT01004107
Last Updated: 2018-07-13
Results Overview
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
3 months from baseline
Results posted on
2018-07-13
Participant Flow
Participant milestones
| Measure |
Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
25
|
|
Overall Study
COMPLETED
|
75
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
Baseline characteristics by cohort
| Measure |
Radiesse Injectable Dermal Filler
n=76 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=25 Participants
Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 8.5 • n=93 Participants
|
56.9 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
57.3 years
STANDARD_DEVIATION 8.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
76 participants
n=93 Participants
|
25 participants
n=4 Participants
|
101 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Fitzpatrick Skin Type
I: burns easily, never tans
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Fitzpatrick Skin Type
II: burns easily, tans minimally with difficulty
|
73 participants
n=93 Participants
|
24 participants
n=4 Participants
|
97 participants
n=27 Participants
|
|
Fitzpatrick Skin Type
III: burns moderately, tans moderately & uniformly
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Fitzpatrick Skin Type
IV: burns minimally, tans moderately & easily
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Fitzpatrick Skin Type
V: rarely burns, tans profusely
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Fitzpatrick Skin Type
VI: never burns, tans profusely
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Hand Dominance
Right
|
68 participants
n=93 Participants
|
24 participants
n=4 Participants
|
92 participants
n=27 Participants
|
|
Hand Dominance
Left
|
8 participants
n=93 Participants
|
1 participants
n=4 Participants
|
9 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 months from baselinePopulation: 3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. 2 subjects were enrolled \& withdrew prior to treatment.
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=152 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=50 Hands
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Baseline
|
2.54 units on a scale
Standard Deviation 0.84
|
2.44 units on a scale
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
3 Months
|
1.72 units on a scale
Standard Deviation 0.73
|
2.44 units on a scale
Standard Deviation 1.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Change from Baseline at 3 Months
|
0.82 units on a scale
Standard Deviation 0.82
|
0.00 units on a scale
Standard Deviation 0.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 months from baselinePopulation: 3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=152 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=50 Hands
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
|
65.8 percentage of hands
|
20.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 months from baselineTo evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=76 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=25 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
|
54.0 percentage of participants
|
4.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: BHVSS: safety analysis set or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled \& withdrew prior to treatment.
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=202 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=198 Hands
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=196 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=196 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
n=150 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
BHVSS Rating
|
2.51 units on a scale
Standard Deviation 0.88
|
1.71 units on a scale
Standard Deviation 0.78
|
1.95 units on a scale
Standard Deviation 0.86
|
1.77 units on a scale
Standard Deviation 0.87
|
1.91 units on a scale
Standard Deviation 0.79
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Change since Baseline
|
NA units on a scale
Standard Deviation NA
This is the baseline evaluation.
|
0.83 units on a scale
Standard Deviation 0.84
|
0.59 units on a scale
Standard Deviation 0.82
|
0.78 units on a scale
Standard Deviation 1.03
|
0.64 units on a scale
Standard Deviation 0.94
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: BHVSS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.
To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=198 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=196 Hands
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=196 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=150 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
|
66.2 percentage of hands
|
56.2 percentage of hands
|
57.7 percentage of hands
|
57.3 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: 3-,6-, 9-, and 12-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. After 3 months, the untreated controls were treated with Radiesse and were followed as per the original treatment group.
To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=98 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
|
51.5 percentage of participants
|
35.7 percentage of participants
|
37.8 percentage of participants
|
34.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months from baselinePopulation: 3-month GAIS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. 2 subjects were enrolled \& withdrew prior to treatment.
To evaluate the efficacy of Radiesse Injectable Dermal Filler for hand treatment as measured by a Global Aesthetic Improvement Scale (GAIS), by hand, as completed by three, blinded evaluators.
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=152 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=50 Hands
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Very Much Improved
|
15.1 percentage of hands
|
4.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Much Improved
|
45.4 percentage of hands
|
8.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Improved
|
30.3 percentage of hands
|
26.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
No Change
|
7.2 percentage of hands
|
52.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Worse
|
2.0 percentage of hands
|
10.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Much Worse
|
0.0 percentage of hands
|
0.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Very Much Worse
|
0.0 percentage of hands
|
0.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Total Improved
|
90.8 percentage of hands
|
38.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months from baselinePopulation: 3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once
Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=76 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=25 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only
|
84.2 percentage of participants
|
24.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: GAIS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.
To evaluate the efficacy of Radiesse for hand treatment as measured by Global Aesthetic Improvement Scale (GAIS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators.
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=198 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=196 Hands
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=196 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=150 Hands
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Very Much Improved
|
15.2 percentage of hands
|
8.7 percentage of hands
|
0.5 percentage of hands
|
0.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Much Improved
|
43.9 percentage of hands
|
29.1 percentage of hands
|
7.1 percentage of hands
|
7.3 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Improved
|
29.8 percentage of hands
|
37.2 percentage of hands
|
41.8 percentage of hands
|
43.3 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
No Change
|
8.6 percentage of hands
|
17.9 percentage of hands
|
39.8 percentage of hands
|
36.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Worse
|
2.0 percentage of hands
|
5.6 percentage of hands
|
10.7 percentage of hands
|
13.3 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Much Worse
|
0.5 percentage of hands
|
1.5 percentage of hands
|
0.0 percentage of hands
|
0.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Very Much Worse
|
0.0 percentage of hands
|
0.0 percentage of hands
|
0.0 percentage of hands
|
0.0 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Total Improved
|
88.9 percentage of hands
|
75.0 percentage of hands
|
49.5 percentage of hands
|
50.7 percentage of hands
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: GAIS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.
Effectiveness was measured by evaluating changes in hand appearance, by subject, between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects using the GAIS completed by three, blinded evaluators
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=98 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study
|
78.8 percentage of participants
|
62.2 percentage of participants
|
29.6 percentage of participants
|
28.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled \& withdrew prior to treatment.
Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among physicians between baseline and 3, 6, 9 and 12 months, by subject
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=98 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Physician Satisfaction Evaluation
Extrememly Satisfied
|
26.3 percentage of physicians
|
30.6 percentage of physicians
|
18.4 percentage of physicians
|
32.0 percentage of physicians
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Physician Satisfaction Evaluation
Satisfied
|
59.6 percentage of physicians
|
57.1 percentage of physicians
|
61.2 percentage of physicians
|
48.0 percentage of physicians
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Physician Satisfaction Evaluation
Slightly Satisfied
|
13.1 percentage of physicians
|
10.2 percentage of physicians
|
16.3 percentage of physicians
|
14.7 percentage of physicians
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Physician Satisfaction Evaluation
Slightly Dissatisfied
|
0.0 percentage of physicians
|
2.0 percentage of physicians
|
1.0 percentage of physicians
|
5.3 percentage of physicians
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Physician Satisfaction Evaluation
Dissatisfied
|
1.0 percentage of physicians
|
0.0 percentage of physicians
|
2.0 percentage of physicians
|
0.0 percentage of physicians
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Physician Satisfaction Evaluation
Extremely Dissatisfied
|
0.0 percentage of physicians
|
0.0 percentage of physicians
|
1.0 percentage of physicians
|
0.0 percentage of physicians
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Physician Satisfaction Evaluation
Total Extremely Satisfied or Satisfied
|
85.9 percentage of physicians
|
87.8 percentage of physicians
|
79.6 percentage of physicians
|
80.0 percentage of physicians
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled \& withdrew prior to treatment.
Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=98 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Evaluation
Extrememly Satisfied
|
33.3 percentage of participants
|
29.6 percentage of participants
|
25.5 percentage of participants
|
30.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation
Satisfied
|
44.4 percentage of participants
|
45.9 percentage of participants
|
44.9 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation
Slightly Satisfied
|
14.1 percentage of participants
|
15.3 percentage of participants
|
21.4 percentage of participants
|
17.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation
Slightly Dissatisfied
|
6.1 percentage of participants
|
4.1 percentage of participants
|
2.0 percentage of participants
|
4.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation
Dissatisfied
|
1.0 percentage of participants
|
5.1 percentage of participants
|
3.1 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation
Extremely Dissatisfied
|
1.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
1.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation
Total Extremely Satisfied or Satisfied
|
77.8 percentage of participants
|
75.5 percentage of participants
|
70.4 percentage of participants
|
70.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled \& withdrew prior to treatment.
Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=98 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Total Extremely Likely or Likely
|
65.7 percentage of participants
|
66.3 percentage of participants
|
65.3 percentage of participants
|
69.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Unlikely
|
5.1 percentage of participants
|
3.1 percentage of participants
|
7.1 percentage of participants
|
5.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Extrememly Likely
|
29.3 percentage of participants
|
34.7 percentage of participants
|
28.6 percentage of participants
|
36.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Likely
|
36.4 percentage of participants
|
31.6 percentage of participants
|
36.7 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Somewhat Likely
|
14.1 percentage of participants
|
19.4 percentage of participants
|
17.4 percentage of participants
|
16.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Somewhat Unlikely
|
13.1 percentage of participants
|
7.1 percentage of participants
|
7.1 percentage of participants
|
4.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Extremely Unlikely
|
2.0 percentage of participants
|
4.1 percentage of participants
|
3.1 percentage of participants
|
5.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3, 6, 9, and 12 months post-treatmentPopulation: Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 1 subject did not complete questionnaire at 6 months.
Effectiveness was measured by evaluating subject's hand function during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Questions were as follows and were graded by subject as 1 = very good, 2 = good, 3 = fair, 4 = poor, and 5 = very poor: 1. Overall, how well did you hand work? 2. How well did your fingers move? 3. How well did your wrist move? 4. How was the strength in your hand? 5. How was the sensation (feeling) in your hand?
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=99 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=97 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
n=97 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Hand Function Rating During Prior Week
How well did your fingers move?
|
1.19 units on a scale
Standard Deviation 0.49
|
1.13 units on a scale
Standard Deviation 0.44
|
1.09 units on a scale
Standard Deviation 0.29
|
1.05 units on a scale
Standard Deviation 0.22
|
1.09 units on a scale
Standard Deviation 0.34
|
1.21 units on a scale
Standard Deviation 0.56
|
1.18 units on a scale
Standard Deviation 0.50
|
1.08 units on a scale
Standard Deviation 0.28
|
1.05 units on a scale
Standard Deviation 0.22
|
1.08 units on a scale
Standard Deviation 0.27
|
|
Mean Hand Function Rating During Prior Week
How well did your hand work?
|
1.21 units on a scale
Standard Deviation 0.56
|
1.14 units on a scale
Standard Deviation 0.43
|
1.09 units on a scale
Standard Deviation 0.29
|
1.06 units on a scale
Standard Deviation 0.28
|
1.12 units on a scale
Standard Deviation 0.37
|
1.22 units on a scale
Standard Deviation 0.58
|
1.17 units on a scale
Standard Deviation 0.47
|
1.09 units on a scale
Standard Deviation 0.29
|
1.05 units on a scale
Standard Deviation 0.22
|
1.13 units on a scale
Standard Deviation 0.34
|
|
Mean Hand Function Rating During Prior Week
How well did your wrist move?
|
1.14 units on a scale
Standard Deviation 0.38
|
1.11 units on a scale
Standard Deviation 0.40
|
1.08 units on a scale
Standard Deviation 0.31
|
1.07 units on a scale
Standard Deviation 0.36
|
1.11 units on a scale
Standard Deviation 0.35
|
1.14 units on a scale
Standard Deviation 0.35
|
1.15 units on a scale
Standard Deviation 0.46
|
1.11 units on a scale
Standard Deviation 0.41
|
1.05 units on a scale
Standard Deviation 0.22
|
1.12 units on a scale
Standard Deviation 0.33
|
|
Mean Hand Function Rating During Prior Week
How was the strength in your hand?
|
1.28 units on a scale
Standard Deviation 0.64
|
1.20 units on a scale
Standard Deviation 0.49
|
1.15 units on a scale
Standard Deviation 0.42
|
1.15 units on a scale
Standard Deviation 0.44
|
1.19 units on a scale
Standard Deviation 0.43
|
1.43 units on a scale
Standard Deviation 0.73
|
1.26 units on a scale
Standard Deviation 0.56
|
1.18 units on a scale
Standard Deviation 0.41
|
1.15 units on a scale
Standard Deviation 0.36
|
1.21 units on a scale
Standard Deviation 0.44
|
|
Mean Hand Function Rating During Prior Week
How was the sensation in your hand?
|
1.19 units on a scale
Standard Deviation 0.47
|
1.20 units on a scale
Standard Deviation 0.51
|
1.13 units on a scale
Standard Deviation 0.34
|
1.07 units on a scale
Standard Deviation 0.26
|
1.18 units on a scale
Standard Deviation 0.42
|
1.26 units on a scale
Standard Deviation 0.63
|
1.19 units on a scale
Standard Deviation 0.47
|
1.15 units on a scale
Standard Deviation 0.36
|
1.10 units on a scale
Standard Deviation 0.30
|
1.13 units on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline and 3, 6, 9, and 12 months post-treatmentPopulation: Safety analysis set; see previously reported population description. 1 subject did not complete baseline, right hand questionnaire. 2 subjects did not complete baseline, left hand questionnaire.1 subject did not complete 6-month questionnaire for either hand.
Effectiveness was measured by evaluating subject's difficulty in performing routine activities during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult: 1. Turn a knob 2. Pick up a coin 3. Hold a glass of water 4. Turn a key in a lock 5. Hold a frying pan
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=99 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=97 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
n=97 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
n=99 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
n=97 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Difficulty Performing Activities During Prior Week
Pick up a coin
|
1.07 units on a scale
Standard Deviation 0.33
|
1.12 units on a scale
Standard Deviation 0.54
|
1.04 units on a scale
Standard Deviation 0.25
|
1.06 units on a scale
Standard Deviation 0.43
|
1.05 units on a scale
Standard Deviation 0.46
|
1.12 units on a scale
Standard Deviation 0.39
|
1.07 units on a scale
Standard Deviation 0.38
|
1.05 units on a scale
Standard Deviation 0.30
|
1.04 units on a scale
Standard Deviation 0.20
|
1.03 units on a scale
Standard Deviation 0.16
|
|
Difficulty Performing Activities During Prior Week
Turn a knob
|
1.01 units on a scale
Standard Deviation 0.10
|
1.05 units on a scale
Standard Deviation 0.33
|
1.02 units on a scale
Standard Deviation 0.14
|
1.05 units on a scale
Standard Deviation 0.42
|
1.05 units on a scale
Standard Deviation 0.46
|
1.08 units on a scale
Standard Deviation 0.28
|
1.07 units on a scale
Standard Deviation 0.38
|
1.05 units on a scale
Standard Deviation 0
|
1.03 units on a scale
Standard Deviation 0.17
|
1.04 units on a scale
Standard Deviation 0.2
|
|
Difficulty Performing Activities During Prior Week
Hold a glass of water
|
1.03 units on a scale
Standard Deviation 0.22
|
1.05 units on a scale
Standard Deviation 0.33
|
1.01 units on a scale
Standard Deviation 0.10
|
1.04 units on a scale
Standard Deviation 0.40
|
1.05 units on a scale
Standard Deviation 0.46
|
1.08 units on a scale
Standard Deviation 0.31
|
1.06 units on a scale
Standard Deviation 0.37
|
1.02 units on a scale
Standard Deviation 0.14
|
1.03 units on a scale
Standard Deviation 0.17
|
1.03 units on a scale
Standard Deviation 0.16
|
|
Difficulty Performing Activities During Prior Week
Turn a key in a lock
|
1.03 units on a scale
Standard Deviation 0.17
|
1.09 units on a scale
Standard Deviation 0.52
|
1.04 units on a scale
Standard Deviation 0.25
|
1.09 units on a scale
Standard Deviation 0.48
|
1.08 units on a scale
Standard Deviation 0.49
|
1.11 units on a scale
Standard Deviation 0.35
|
1.09 units on a scale
Standard Deviation 0.41
|
1.06 units on a scale
Standard Deviation 0.28
|
1.08 units on a scale
Standard Deviation 0.28
|
1.07 units on a scale
Standard Deviation 0.25
|
|
Difficulty Performing Activities During Prior Week
Hold a frying pan
|
1.08 units on a scale
Standard Deviation 0.31
|
1.12 units on a scale
Standard Deviation 0.54
|
1.05 units on a scale
Standard Deviation 0.27
|
1.12 units on a scale
Standard Deviation 0.52
|
1.08 units on a scale
Standard Deviation 0.49
|
1.11 units on a scale
Standard Deviation 0.35
|
1.09 units on a scale
Standard Deviation 0.41
|
1.06 units on a scale
Standard Deviation 0.28
|
1.06 units on a scale
Standard Deviation 0.24
|
1.07 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline and 3, 6, 9, and 12 months post-treatmentPopulation: Safety analysis set; see previously reported population description. 1 subject did not complete baseline questionnaire; 1 subject did not complete 6-month questionnaire.
Effectiveness was measured by evaluating subject's difficulty in performing routine activities, that require both hands, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult: 1. Open a jar 2. Button a shirt / blouse 3. Eat with a knife and fork 4. Carry a grocery bag 5. Wash dishes 6. Wash your hair 7. Tie shoelaces / knots
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=99 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=97 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Difficulty Performing Activities During Prior Week, Both Hands
Tie shoelaces / knots
|
1.08 units on a scale
Standard Deviation 0.31
|
1.07 units on a scale
Standard Deviation 0.38
|
1.02 units on a scale
Standard Deviation 0.14
|
1.03 units on a scale
Standard Deviation 0.17
|
1.03 units on a scale
Standard Deviation 0.23
|
—
|
—
|
—
|
—
|
—
|
|
Difficulty Performing Activities During Prior Week, Both Hands
Open a jar
|
1.20 units on a scale
Standard Deviation 0.63
|
1.18 units on a scale
Standard Deviation 0.58
|
1.13 units on a scale
Standard Deviation 0.47
|
1.11 units on a scale
Standard Deviation 0.35
|
1.09 units on a scale
Standard Deviation 0.37
|
—
|
—
|
—
|
—
|
—
|
|
Difficulty Performing Activities During Prior Week, Both Hands
Button a shirt / blouse
|
1.14 units on a scale
Standard Deviation 0.45
|
1.06 units on a scale
Standard Deviation 0.34
|
1.05 units on a scale
Standard Deviation 0.27
|
1.12 units on a scale
Standard Deviation 0.39
|
1.07 units on a scale
Standard Deviation 0.3
|
—
|
—
|
—
|
—
|
—
|
|
Difficulty Performing Activities During Prior Week, Both Hands
Eat with a knife and fork
|
1.03 units on a scale
Standard Deviation 0.17
|
1.04 units on a scale
Standard Deviation 0.32
|
1.01 units on a scale
Standard Deviation 0.10
|
1.02 units on a scale
Standard Deviation 0.14
|
1.00 units on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
|
Difficulty Performing Activities During Prior Week, Both Hands
Carry a grocery bag
|
1.12 units on a scale
Standard Deviation 0.41
|
1.08 units on a scale
Standard Deviation 0.40
|
1.04 units on a scale
Standard Deviation 0.25
|
1.04 units on a scale
Standard Deviation 0.20
|
1.00 units on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
|
Difficulty Performing Activities During Prior Week, Both Hands
Wash dishes
|
1.09 units on a scale
Standard Deviation 0.38
|
1.05 units on a scale
Standard Deviation 0.36
|
1.01 units on a scale
Standard Deviation 0.10
|
1.01 units on a scale
Standard Deviation 0.10
|
1.01 units on a scale
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
—
|
|
Difficulty Performing Activities During Prior Week, Both Hands
Wash your hair
|
1.09 units on a scale
Standard Deviation 0.35
|
1.04 units on a scale
Standard Deviation 0.32
|
1.01 units on a scale
Standard Deviation 0.10
|
1.03 units on a scale
Standard Deviation 0.22
|
1.01 units on a scale
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3, 6, 9, and 12 months post-treatmentPopulation: Safety analysis set; see previously reported population description. 1 subject did not complete baseline questionnaire; 1 subject did not complete 6-month questionnaire.
Effectiveness was measured by evaluating subject's ability to work normally, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never: 1. How often were you unable to do your work because of problems with your hand(s) / wrist(s)? 2. How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)? 3. How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)? 4. How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)? 5. How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)?
Outcome measures
| Measure |
Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=99 Participants
Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
|
6 Months Post-treatment: Radiesse Injectable Dermal Filler
n=97 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months Post-treatment: Radiesse Injectable Dermal Filler
n=98 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months Post-treatment: Radiesse Injectable Dermal Filler
n=75 Participants
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Baseline, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
3 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
6 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
9 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
12 Months, Left Hand: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Normal Work During Prior Week Evaluation
Unable to do your work?
|
4.80 units on a scale
Standard Deviation 0.81
|
4.93 units on a scale
Standard Deviation 0.46
|
4.88 units on a scale
Standard Deviation 0.62
|
4.99 units on a scale
Standard Deviation 0.10
|
4.96 units on a scale
Standard Deviation 0.20
|
—
|
—
|
—
|
—
|
—
|
|
Normal Work During Prior Week Evaluation
Shorten your work day?
|
4.79 units on a scale
Standard Deviation 0.82
|
4.92 units on a scale
Standard Deviation 0.49
|
4.87 units on a scale
Standard Deviation 0.61
|
4.97 units on a scale
Standard Deviation 0.17
|
4.96 units on a scale
Standard Deviation 0.20
|
—
|
—
|
—
|
—
|
—
|
|
Normal Work During Prior Week Evaluation
Take it easy at your work?
|
4.73 units on a scale
Standard Deviation 0.84
|
4.90 units on a scale
Standard Deviation 0.50
|
4.88 units on a scale
Standard Deviation 0.60
|
4.93 units on a scale
Standard Deviation 0.30
|
4.89 units on a scale
Standard Deviation 0.42
|
—
|
—
|
—
|
—
|
—
|
|
Normal Work During Prior Week Evaluation
Accomplish less in your work?
|
4.73 units on a scale
Standard Deviation 0.84
|
4.91 units on a scale
Standard Deviation 0.50
|
4.88 units on a scale
Standard Deviation 0.62
|
4.96 units on a scale
Standard Deviation 0.20
|
4.96 units on a scale
Standard Deviation 0.20
|
—
|
—
|
—
|
—
|
—
|
|
Normal Work During Prior Week Evaluation
Take longer to do tasks?
|
4.73 units on a scale
Standard Deviation 0.64
|
4.88 units on a scale
Standard Deviation 0.58
|
4.87 units on a scale
Standard Deviation 0.62
|
4.93 units on a scale
Standard Deviation 0.26
|
4.89 units on a scale
Standard Deviation 0.53
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Radiesse Injectable Dermal Filler
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radiesse Injectable Dermal Filler
n=99 participants at risk
Device: Radiesse Injectable Dermal Filler
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
5.1%
5/99
Two patients were enrolled and then withdrew prior to treatment, leaving 99 of the original 101 participants (98%).
|
|
Skin and subcutaneous tissue disorders
Swelling
|
3.0%
3/99
Two patients were enrolled and then withdrew prior to treatment, leaving 99 of the original 101 participants (98%).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place