Trial Outcomes & Findings for Evaluation of Radiesse® Dermal Filler for Hand Treatment (NCT NCT01832090)
NCT ID: NCT01832090
Last Updated: 2017-10-19
Results Overview
To evaluate the efficacy of Radiesse for hand treatment as measured by a mean change on the 5-point Merz Hand Grading Scale (MHGS) 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 MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
COMPLETED
NA
118 participants
3 months from baseline
2017-10-19
Participant Flow
Participant milestones
| Measure |
Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
29
|
|
Overall Study
COMPLETED
|
83
|
28
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Radiesse® Dermal Filler for Hand Treatment
Baseline characteristics by cohort
| Measure |
Radiesse® Injectable Dermal Filler
n=85 Participants
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Delayed Treatment
n=29 Participants
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
66 participants
n=5 Participants
|
21 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 participants
n=5 Participants
|
3 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
I: burns easily, never tans
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
II: burns easily, tans minimally with difficulty
|
45 participants
n=5 Participants
|
11 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
III: burns moderately, tans moderately & uniformly
|
19 participants
n=5 Participants
|
11 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
IV: burns minimally, tans moderately & easily
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
V: rarely burns, tans profusely
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
VI: never burns, tans profusely
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Hand Dominance
Right
|
79 participants
n=5 Participants
|
26 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Hand Dominance
Left
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months from baselinePopulation: All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as "No change" for the primary endpoint.
To evaluate the efficacy of Radiesse for hand treatment as measured by a mean change on the 5-point Merz Hand Grading Scale (MHGS) 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 MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=170 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=58 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
Mean Change on Merz Hand Grading Scale (MHGS), by Hand
Baseline
|
2.6 units on a scale
Standard Deviation 0.5
|
2.6 units on a scale
Standard Deviation 0.5
|
—
|
—
|
—
|
—
|
|
Mean Change on Merz Hand Grading Scale (MHGS), by Hand
3 Months
|
1.5 units on a scale
Standard Deviation 0.8
|
2.6 units on a scale
Standard Deviation 0.5
|
—
|
—
|
—
|
—
|
|
Mean Change on Merz Hand Grading Scale (MHGS), by Hand
Change from Baseline at 3 Months
|
-1.1 units on a scale
Standard Deviation 0.9
|
-0.1 units on a scale
Standard Deviation 0.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 months from baselinePopulation: All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as "No change" for the primary endpoint.
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) 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 MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=170 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=58 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand
|
77.1 percentage of hands
|
5.2 percentage of hands
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 months from baselinePopulation: All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as "No change" for the primary endpoint.
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) 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 MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=85 Participants
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=29 Participants
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject
|
75.3 percentage of participants
|
3.4 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months from baselinePopulation: Single withdrawn subject imputed as "no change"
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age \< 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=134 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=36 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
n=36 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
n=22 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
Baseline
|
2.5 units on a scale
Standard Deviation 0.5
|
2.5 units on a scale
Standard Deviation 0.5
|
2.7 units on a scale
Standard Deviation 0.5
|
2.7 units on a scale
Standard Deviation 0.5
|
—
|
—
|
|
Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
3 Months
|
1.4 units on a scale
Standard Deviation 0.8
|
2.4 units on a scale
Standard Deviation 0.5
|
1.7 units on a scale
Standard Deviation 0.8
|
2.7 units on a scale
Standard Deviation 0.5
|
—
|
—
|
|
Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
Change from Baseline at 3 Months
|
-1.1 units on a scale
Standard Deviation 0.9
|
-0.1 units on a scale
Standard Deviation 0.3
|
-1.0 units on a scale
Standard Deviation 0.8
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months from baselinePopulation: Single withdrawn subject imputed as "no change"
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age \< 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=170 Hand
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=58 Hand
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
Age < 60 years
|
78.4 percentage of hands
|
8.3 percentage of hands
|
—
|
—
|
—
|
—
|
|
≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
Age ≥ 60 years
|
72.2 percentage of hands
|
0.0 percentage of hands
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months from baselinePopulation: Single withdrawn subject imputed as "no change"
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls, stratified by age \< 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=85 Participants
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=29 Participants
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
Age < 60 years
|
76.1 percentage of participants
|
5.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
Age ≥ 60 years
|
72.2 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months from baselinePopulation: Single withdrawn subject imputed as "no change"
To evaluate the efficacy of Radiesse for hand treatment by comparing the evenness in the left hand versus the right hand at 3 months using the 5-point Merz Hand Grading Scale (MHGS) among the original treatment group only. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=85 Participants
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only
0 points
|
84.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only
1 point
|
15.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only
> 1 point
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months from baselinePopulation: Single withdrawn subject imputed as "no change"
To evaluate the efficacy of Radiesse for hand treatment by evaluating subject-reported, live Global Aesthetic Improvement Scale (GAIS) ratings at 3 months when compared to baseline among the original treatment group only
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=170 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
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 Only
Very Much Improved
|
31.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only
Much Improved
|
44.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only
Improved
|
21.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only
No Change
|
2.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only
Worse
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only
Total: At least "Improved"
|
97.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: Single withdrawn subject did not receive treatment and is not included in this analysis.
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=72 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=72 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
n=72 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
n=72 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
n=46 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment
|
2.5 units on a scale
Standard Deviation 0.5
|
1.3 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 0.9
|
1.4 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: Single withdrawn subject did not receive treatment and is not included in this analysis.
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects receiving retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=154 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=154 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
n=154 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
n=154 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
n=120 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment
|
2.6 units on a scale
Standard Deviation 0.5
|
1.5 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 0.7
|
1.4 units on a scale
Standard Deviation 0.7
|
1.3 units on a scale
Standard Deviation 0.6
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: Single withdrawn subject did not receive treatment and is not included in this analysis.
To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=154 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=120 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
n=72 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
n=23 Participants
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment
|
83.1 % hands with ≥ 1 point MHGS change
|
88.3 % hands with ≥ 1 point MHGS change
|
73.6 % hands with ≥ 1 point MHGS change
|
71.7 % hands with ≥ 1 point MHGS change
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: Single withdrawn subject did not receive treatment and is not included in this analysis.
To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score. MHGS categories are as follows: 0 = no loss of fatty tissue; 1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=78 Participants
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=61 Participants
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
n=35 Participants
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
n=22 Participants
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment
|
82.1 percentage of participants
|
88.5 percentage of participants
|
71.4 percentage of participants
|
68.2 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months from baselinePopulation: Single withdrawn subject did not receive treatment and is not included in this analysis.
To evaluate the efficacy of Radiesse for hand treatment as measured by live, subject-completed Global Aesthetic Improvement Scale (GAIS) scores between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment
Outcome measures
| Measure |
Radiesse® Injectable Dermal Filler
n=226 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Delayed Treatment
n=226 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Radiesse® Injectable Dermal Filler
n=70 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
Age ≥ 60 and Delayed Treatment
n=44 Hands
Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
12 Months Post-treatment: Radiesse® Injectable Dermal Filler
n=154 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
6 Months Post-retreatment: Radiesse® Injectable Dermal Filler
n=122 Hands
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse® Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
|
|---|---|---|---|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment
Very Much Improved
|
29.2 percentage of participants
|
41.6 percentage of participants
|
32.9 percentage of participants
|
11.4 percentage of participants
|
44.2 percentage of participants
|
43.4 percentage of participants
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment
Much Improved
|
44.7 percentage of participants
|
30.5 percentage of participants
|
34.3 percentage of participants
|
40.9 percentage of participants
|
39.0 percentage of participants
|
24.6 percentage of participants
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment
Improved
|
24.3 percentage of participants
|
21.2 percentage of participants
|
27.1 percentage of participants
|
34.1 percentage of participants
|
15.6 percentage of participants
|
27.0 percentage of participants
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment
No Change
|
1.8 percentage of participants
|
6.6 percentage of participants
|
5.7 percentage of participants
|
13.6 percentage of participants
|
1.3 percentage of participants
|
4.9 percentage of participants
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment
Worse
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment
Total: At least "Improved"
|
98.2 percentage of participants
|
93.4 percentage of participants
|
94.3 percentage of participants
|
86.4 percentage of participants
|
98.7 percentage of participants
|
95.1 percentage of participants
|
Adverse Events
Radiesse® Injectable Dermal Filler
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radiesse® Injectable Dermal Filler
n=113 participants at risk
Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)
Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
18.6%
21/113
113 of 114 subjects (99%) completed the main study through 3 months. One subject randomized to the control group suffered a non-study related broken hand after enrollment but prior to 3 month follow up and treatment. This subject's effectiveness data were imputed as "No change" for the purposes of the primary effectiveness analysis.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
20.4%
23/113
113 of 114 subjects (99%) completed the main study through 3 months. One subject randomized to the control group suffered a non-study related broken hand after enrollment but prior to 3 month follow up and treatment. This subject's effectiveness data were imputed as "No change" for the purposes of the primary effectiveness analysis.
|
|
Skin and subcutaneous tissue disorders
Redness
|
8.0%
9/113
113 of 114 subjects (99%) completed the main study through 3 months. One subject randomized to the control group suffered a non-study related broken hand after enrollment but prior to 3 month follow up and treatment. This subject's effectiveness data were imputed as "No change" for the purposes of the primary effectiveness analysis.
|
|
Skin and subcutaneous tissue disorders
Itching
|
3.5%
4/113
113 of 114 subjects (99%) completed the main study through 3 months. One subject randomized to the control group suffered a non-study related broken hand after enrollment but prior to 3 month follow up and treatment. This subject's effectiveness data were imputed as "No change" for the purposes of the primary effectiveness analysis.
|
|
Skin and subcutaneous tissue disorders
Pain
|
6.2%
7/113
113 of 114 subjects (99%) completed the main study through 3 months. One subject randomized to the control group suffered a non-study related broken hand after enrollment but prior to 3 month follow up and treatment. This subject's effectiveness data were imputed as "No change" for the purposes of the primary effectiveness analysis.
|
|
Skin and subcutaneous tissue disorders
Nodule, Bumps/Lumps
|
6.2%
7/113
113 of 114 subjects (99%) completed the main study through 3 months. One subject randomized to the control group suffered a non-study related broken hand after enrollment but prior to 3 month follow up and treatment. This subject's effectiveness data were imputed as "No change" for the purposes of the primary effectiveness analysis.
|
|
Skin and subcutaneous tissue disorders
Other, not within pre-defined (expected) AE categories
|
11.5%
13/113
113 of 114 subjects (99%) completed the main study through 3 months. One subject randomized to the control group suffered a non-study related broken hand after enrollment but prior to 3 month follow up and treatment. This subject's effectiveness data were imputed as "No change" for the purposes of the primary effectiveness analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place