Aging Hands
Conditions
Keywords
aging, hands
Brief summary
The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.
Detailed description
This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.
Interventions
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
Sponsors
Merz Aesthetics Inc.
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Has right and left hands with rating of 2 or 3 on the Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator * Is at least 18 years of age
Exclusion criteria
* Has history of hypertropic scarring * Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection * Has a known hypersensitivity to any of the components of Radiesse or local anesthesia * Has received in past 6 months or plans to receive during the study dermal resurfacing procedure (chemical peel, dermabrasion, ablative laser resurfacing) or non-invasive skin tightening (Thermage®) in the dorsum of the hands * Has received in past 2 weeks or plans to receive during the study prescription wrinkle therapies, topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) in the dorsum of the hands * Has had any dermal fillers or surgery in the dorsum of the hand
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change on Merz Hand Grading Scale (MHGS), by Hand | 3 months from baseline | 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. |
| ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand | 3 months from baseline | 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. |
| ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject | 3 months from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only | 3 months from baseline | 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. |
| Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only | 3 months from baseline | 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 |
| Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment | 3, 6, 9, and 12 months from baseline | 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. |
| Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | 3 months from baseline | 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. |
| ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment | 3, 6, 9, and 12 months from baseline | 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. |
| ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment | 3, 6, 9, and 12 months from baseline | 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. |
| Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | 3, 6, 9, and 12 months from baseline | 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 |
| Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment | 3, 6, 9, and 12 months from baseline | 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. |
| ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | 3 months from baseline | 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. |
| ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | 3 months from baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 85 |
| 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 | 29 |
| Total | 114 |
Baseline characteristics
| Characteristic | Radiesse® Injectable Dermal Filler | Delayed Treatment | Total |
|---|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 8 | 54.8 years STANDARD_DEVIATION 10.6 | 53.3 years STANDARD_DEVIATION 8.7 |
| Fitzpatrick Skin Type I: burns easily, never tans | 3 participants | 0 participants | 3 participants |
| Fitzpatrick Skin Type II: burns easily, tans minimally with difficulty | 45 participants | 11 participants | 56 participants |
| Fitzpatrick Skin Type III: burns moderately, tans moderately & uniformly | 19 participants | 11 participants | 30 participants |
| Fitzpatrick Skin Type IV: burns minimally, tans moderately & easily | 13 participants | 4 participants | 17 participants |
| Fitzpatrick Skin Type VI: never burns, tans profusely | 1 participants | 1 participants | 2 participants |
| Fitzpatrick Skin Type V: rarely burns, tans profusely | 4 participants | 2 participants | 6 participants |
| Hand Dominance Left | 6 participants | 3 participants | 9 participants |
| Hand Dominance Right | 79 participants | 26 participants | 105 participants |
| Race/Ethnicity, Customized African American | 3 participants | 3 participants | 6 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Caucasian | 66 participants | 21 participants | 87 participants |
| Race/Ethnicity, Customized Hispanic | 12 participants | 3 participants | 15 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 81 Participants | 28 Participants | 109 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 113 |
| serious Total, serious adverse events | 0 / 113 |
Outcome results
Primary
≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand
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.
Time frame: 3 months from baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiesse® Injectable Dermal Filler | ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand | 77.1 percentage of hands |
| Delayed Treatment | ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand | 5.2 percentage of hands |
p-value: <0.0001Fisher Exact
Primary
≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject
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.
Time frame: 3 months from baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiesse® Injectable Dermal Filler | ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject | 75.3 percentage of participants |
| Delayed Treatment | ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject | 3.4 percentage of participants |
p-value: <0.0001Fisher Exact
Primary
Mean Change on Merz Hand Grading Scale (MHGS), by Hand
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.
Time frame: 3 months from baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiesse® Injectable Dermal Filler | Mean Change on Merz Hand Grading Scale (MHGS), by Hand | Baseline | 2.6 units on a scale | Standard Deviation 0.5 |
| Radiesse® Injectable Dermal Filler | Mean Change on Merz Hand Grading Scale (MHGS), by Hand | 3 Months | 1.5 units on a scale | Standard Deviation 0.8 |
| Radiesse® Injectable Dermal Filler | 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 |
| Delayed Treatment | Mean Change on Merz Hand Grading Scale (MHGS), by Hand | Baseline | 2.6 units on a scale | Standard Deviation 0.5 |
| Delayed Treatment | Mean Change on Merz Hand Grading Scale (MHGS), by Hand | 3 Months | 2.6 units on a scale | Standard Deviation 0.5 |
| Delayed Treatment | Mean Change on Merz Hand Grading Scale (MHGS), by Hand | Change from Baseline at 3 Months | -0.1 units on a scale | Standard Deviation 0.2 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
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.
Time frame: 3 months from baseline
Population: Single withdrawn subject imputed as no change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiesse® Injectable Dermal Filler | ≥ 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 |
| Radiesse® Injectable Dermal Filler | ≥ 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 |
| Delayed Treatment | ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | Age < 60 years | 8.3 percentage of hands |
| Delayed Treatment | ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | Age ≥ 60 years | 0.0 percentage of hands |
p-value: >0.05Fisher Exact
Secondary
≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
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.
Time frame: 3 months from baseline
Population: Single withdrawn subject imputed as no change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiesse® Injectable Dermal Filler | ≥ 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 |
| Radiesse® Injectable Dermal Filler | ≥ 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 |
| Delayed Treatment | ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | Age < 60 years | 5.6 percentage of participants |
| Delayed Treatment | ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | Age ≥ 60 years | 0.0 percentage of participants |
p-value: >0.05Fisher Exact
Secondary
≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment
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.
Time frame: 3, 6, 9, and 12 months from baseline
Population: Single withdrawn subject did not receive treatment and is not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiesse® Injectable Dermal Filler | ≥ 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 |
| Delayed Treatment | ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment | 88.3 % hands with ≥ 1 point MHGS change |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment | 73.6 % hands with ≥ 1 point MHGS change |
| Age ≥ 60 and Delayed Treatment | ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment | 71.7 % hands with ≥ 1 point MHGS change |
Secondary
≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment
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.
Time frame: 3, 6, 9, and 12 months from baseline
Population: Single withdrawn subject did not receive treatment and is not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiesse® Injectable Dermal Filler | ≥ 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 |
| Delayed Treatment | ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment | 88.5 percentage of participants |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment | 71.4 percentage of participants |
| Age ≥ 60 and Delayed Treatment | ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment | 68.2 percentage of participants |
Secondary
Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only
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.
Time frame: 3 months from baseline
Population: Single withdrawn subject imputed as no change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiesse® Injectable Dermal Filler | 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 |
| Radiesse® Injectable Dermal Filler | 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 |
| Radiesse® Injectable Dermal Filler | 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
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only
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
Time frame: 3 months from baseline
Population: Single withdrawn subject imputed as no change
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only | Very Much Improved | 31.8 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only | Much Improved | 44.1 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only | Improved | 21.8 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only | No Change | 2.4 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only | Worse | 0.0 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only | Total: At least Improved | 97.6 percentage of participants |
Secondary
Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment
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
Time frame: 3, 6, 9, and 12 months from baseline
Population: Single withdrawn subject did not receive treatment and is not included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiesse® Injectable Dermal Filler | 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 |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Improved | 24.3 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Much Improved | 44.7 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | No Change | 1.8 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Worse | 0 percentage of participants |
| Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Very Much Improved | 29.2 percentage of participants |
| Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Total: At least Improved | 93.4 percentage of participants |
| Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | No Change | 6.6 percentage of participants |
| Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Improved | 21.2 percentage of participants |
| Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Worse | 0 percentage of participants |
| Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Very Much Improved | 41.6 percentage of participants |
| Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Much Improved | 30.5 percentage of participants |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Very Much Improved | 32.9 percentage of participants |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Worse | 0 percentage of participants |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Much Improved | 34.3 percentage of participants |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Improved | 27.1 percentage of participants |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | No Change | 5.7 percentage of participants |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Total: At least Improved | 94.3 percentage of participants |
| Age ≥ 60 and Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Much Improved | 40.9 percentage of participants |
| Age ≥ 60 and Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | No Change | 13.6 percentage of participants |
| Age ≥ 60 and Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Very Much Improved | 11.4 percentage of participants |
| Age ≥ 60 and Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Worse | 0 percentage of participants |
| Age ≥ 60 and Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Total: At least Improved | 86.4 percentage of participants |
| Age ≥ 60 and Delayed Treatment | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Improved | 34.1 percentage of participants |
| 12 Months Post-treatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Worse | 0 percentage of participants |
| 12 Months Post-treatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Total: At least Improved | 98.7 percentage of participants |
| 12 Months Post-treatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | No Change | 1.3 percentage of participants |
| 12 Months Post-treatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Improved | 15.6 percentage of participants |
| 12 Months Post-treatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Very Much Improved | 44.2 percentage of participants |
| 12 Months Post-treatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Much Improved | 39.0 percentage of participants |
| 6 Months Post-retreatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Total: At least Improved | 95.1 percentage of participants |
| 6 Months Post-retreatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Very Much Improved | 43.4 percentage of participants |
| 6 Months Post-retreatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Improved | 27.0 percentage of participants |
| 6 Months Post-retreatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | No Change | 4.9 percentage of participants |
| 6 Months Post-retreatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Worse | 0 percentage of participants |
| 6 Months Post-retreatment: Radiesse® Injectable Dermal Filler | Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment | Much Improved | 24.6 percentage of participants |
Secondary
Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
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.
Time frame: 3 months from baseline
Population: Single withdrawn subject imputed as no change
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiesse® Injectable Dermal Filler | 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 |
| Radiesse® Injectable Dermal Filler | 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 |
| Radiesse® Injectable Dermal Filler | 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 |
| Delayed Treatment | 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 |
| Delayed Treatment | 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 | -0.1 units on a scale | Standard Deviation 0.3 |
| Delayed Treatment | Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | 3 Months | 2.4 units on a scale | Standard Deviation 0.5 |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | 3 Months | 1.7 units on a scale | Standard Deviation 0.8 |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | Baseline | 2.7 units on a scale | Standard Deviation 0.5 |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | 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 | -1.0 units on a scale | Standard Deviation 0.8 |
| Age ≥ 60 and Delayed Treatment | Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | Baseline | 2.7 units on a scale | Standard Deviation 0.5 |
| Age ≥ 60 and Delayed Treatment | 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 | 0.0 units on a scale | Standard Deviation 0 |
| Age ≥ 60 and Delayed Treatment | Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years | 3 Months | 2.7 units on a scale | Standard Deviation 0.5 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment
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.
Time frame: 3, 6, 9, and 12 months from baseline
Population: Single withdrawn subject did not receive treatment and is not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Injectable Dermal Filler | 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 |
| Delayed Treatment | Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment | 1.3 units on a scale | Standard Deviation 0.8 |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment | 1.3 units on a scale | Standard Deviation 0.9 |
| Age ≥ 60 and Delayed Treatment | Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment | 1.4 units on a scale | Standard Deviation 0.8 |
| 12 Months Post-treatment: Radiesse® Injectable Dermal Filler | Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment | 1.7 units on a scale | Standard Deviation 0.8 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment
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.
Time frame: 3, 6, 9, and 12 months from baseline
Population: Single withdrawn subject did not receive treatment and is not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Injectable Dermal Filler | 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 |
| Delayed Treatment | Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment | 1.5 units on a scale | Standard Deviation 0.8 |
| Age ≥ 60 and Radiesse® Injectable Dermal Filler | Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment | 1.7 units on a scale | Standard Deviation 0.7 |
| Age ≥ 60 and Delayed Treatment | Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment | 1.4 units on a scale | Standard Deviation 0.7 |
| 12 Months Post-treatment: Radiesse® Injectable Dermal Filler | Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment | 1.3 units on a scale | Standard Deviation 0.6 |
p-value: <0.0001Wilcoxon (Mann-Whitney)