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Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01004107
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Aging Hands
Intervention Device: Radiesse Injectable Dermal Filler
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiesse Injectable Dermal Filler Delayed Treatment
Hide Arm/Group Description

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months
Period Title: Overall Study
Started 76 25
Completed 75 23
Not Completed 1 2
Arm/Group Title Radiesse Injectable Dermal Filler Delayed Treatment Total
Hide Arm/Group Description

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months Total of all reporting groups
Overall Number of Baseline Participants 76 25 101
Hide Baseline Analysis Population Description
Safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. Two patients were enrolled and then withdrew prior to treatment, leaving 99 of the original 101 participants (98%).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 25 participants 101 participants
57.4  (8.5) 56.9  (9.0) 57.3  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 25 participants 101 participants
Female
73
  96.1%
23
  92.0%
96
  95.0%
Male
3
   3.9%
2
   8.0%
5
   5.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 25 participants 101 participants
Caucasian 76 25 101
Non-Caucasian 0 0 0
Fitzpatrick Skin Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 25 participants 101 participants
I: burns easily, never tans 1 0 1
II: burns easily, tans minimally with difficulty 73 24 97
III: burns moderately, tans moderately & uniformly 2 1 3
IV: burns minimally, tans moderately & easily 0 0 0
V: rarely burns, tans profusely 0 0 0
VI: never burns, tans profusely 0 0 0
[1]
Measure Description:

The Fitzpatrick Skin Types (FST) represent a standard classification of skin color based on one's response to sun exposure (i.e., burns or tans), rather than defined by race or ethnicity.

All FST were eligible for participation in the current study.

See full FST descriptions in Astner S, Anderson RR. Skin phototypes 2003. J Invest Dermatol. 2004 Feb;122(2):xxx-xxxi.

Hand Dominance  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 25 participants 101 participants
Right 68 24 92
Left 8 1 9
1.Primary Outcome
Title Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Hide Description

To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

Time Frame 3 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. 2 subjects were enrolled & withdrew prior to treatment.
Arm/Group Title Radiesse Injectable Dermal Filler Delayed Treatment
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
Overall Number of Participants Analyzed 76 25
Overall Number of Units Analyzed
Type of Units Analyzed: Hands
152 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.54  (0.84) 2.44  (1.15)
3 Months 1.72  (0.73) 2.44  (1.01)
Change from Baseline at 3 Months 0.82  (0.82) 0.00  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiesse Injectable Dermal Filler, Delayed Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Hide Description

To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

Time Frame 3 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once
Arm/Group Title Radiesse Injectable Dermal Filler Delayed Treatment
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
Overall Number of Participants Analyzed 76 25
Overall Number of Units Analyzed
Type of Units Analyzed: Hands
152 50
Measure Type: Number
Unit of Measure: percentage of hands
65.8 20.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiesse Injectable Dermal Filler, Delayed Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
Hide Description

To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

Time Frame 3 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiesse Injectable Dermal Filler Delayed Treatment
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 76 25
Measure Type: Number
Unit of Measure: percentage of participants
54.0 4.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiesse Injectable Dermal Filler, Delayed Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Hide Description

To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

Time Frame 3, 6, 9, and 12 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BHVSS: safety analysis set or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.
Arm/Group Title Baseline: Radiesse Injectable Dermal Filler 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 101 99 98 98 75
Overall Number of Units Analyzed
Type of Units Analyzed: Hands
202 198 196 196 150
Mean (Standard Deviation)
Unit of Measure: units on a scale
BHVSS Rating 2.51  (0.88) 1.71  (0.78) 1.95  (0.86) 1.77  (0.87) 1.91  (0.79)
Change since Baseline NA [1]   (NA) 0.83  (0.84) 0.59  (0.82) 0.78  (1.03) 0.64  (0.94)
[1]
This is the baseline evaluation.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline: Radiesse Injectable Dermal Filler, 3 Months Post-treatment: Radiesse Injectable Dermal Filler, 6 Months Post-treatment: Radiesse Injectable Dermal Filler, 9 Months Post-treatment: Radiesse Injectable Dermal Filler, 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Hide Description

To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

Time Frame 3, 6, 9, and 12 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BHVSS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.
Arm/Group Title 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 99 98 98 75
Overall Number of Units Analyzed
Type of Units Analyzed: Hands
198 196 196 150
Measure Type: Number
Unit of Measure: percentage of hands
66.2 56.2 57.7 57.3
6.Secondary Outcome
Title ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
Hide Description

To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

Time Frame 3, 6, 9, and 12 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3-,6-, 9-, and 12-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. After 3 months, the untreated controls were treated with Radiesse and were followed as per the original treatment group.
Arm/Group Title 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 99 98 98 75
Measure Type: Number
Unit of Measure: percentage of participants
51.5 35.7 37.8 34.7
7.Secondary Outcome
Title Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Hide Description To evaluate the efficacy of Radiesse Injectable Dermal Filler for hand treatment as measured by a Global Aesthetic Improvement Scale (GAIS), by hand, as completed by three, blinded evaluators.
Time Frame 3 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3-month GAIS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. 2 subjects were enrolled & withdrew prior to treatment.
Arm/Group Title Radiesse Injectable Dermal Filler Delayed Treatment
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
Overall Number of Participants Analyzed 76 25
Overall Number of Units Analyzed
Type of Units Analyzed: Hands
152 50
Measure Type: Number
Unit of Measure: percentage of hands
Very Much Improved 15.1 4.0
Much Improved 45.4 8.0
Improved 30.3 26.0
No Change 7.2 52.0
Worse 2.0 10.0
Much Worse 0.0 0.0
Very Much Worse 0.0 0.0
Total Improved 90.8 38.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiesse Injectable Dermal Filler, Delayed Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only
Hide Description Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators
Time Frame 3 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once
Arm/Group Title Radiesse Injectable Dermal Filler Delayed Treatment
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Untreated controls were crossed over to treatment with Radiesse Injectable Dermal Filler at 3 Months
Overall Number of Participants Analyzed 76 25
Measure Type: Number
Unit of Measure: percentage of participants
84.2 24.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiesse Injectable Dermal Filler, Delayed Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Hide Description To evaluate the efficacy of Radiesse for hand treatment as measured by Global Aesthetic Improvement Scale (GAIS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators.
Time Frame 3, 6, 9, and 12 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
GAIS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.
Arm/Group Title 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 99 98 98 75
Overall Number of Units Analyzed
Type of Units Analyzed: Hands
198 196 196 150
Measure Type: Number
Unit of Measure: percentage of hands
Very Much Improved 15.2 8.7 0.5 0.0
Much Improved 43.9 29.1 7.1 7.3
Improved 29.8 37.2 41.8 43.3
No Change 8.6 17.9 39.8 36.0
Worse 2.0 5.6 10.7 13.3
Much Worse 0.5 1.5 0.0 0.0
Very Much Worse 0.0 0.0 0.0 0.0
Total Improved 88.9 75.0 49.5 50.7
10.Secondary Outcome
Title Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study
Hide Description Effectiveness was measured by evaluating changes in hand appearance, by subject, between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects using the GAIS completed by three, blinded evaluators
Time Frame 3, 6, 9, and 12 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
GAIS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.
Arm/Group Title 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 99 98 98 75
Measure Type: Number
Unit of Measure: percentage of participants
78.8 62.2 29.6 28.0
11.Secondary Outcome
Title Physician Satisfaction Evaluation
Hide Description Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among physicians between baseline and 3, 6, 9 and 12 months, by subject
Time Frame 3, 6, 9, and 12 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.
Arm/Group Title 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 99 98 98 75
Measure Type: Number
Unit of Measure: percentage of physicians
Extrememly Satisfied 26.3 30.6 18.4 32.0
Satisfied 59.6 57.1 61.2 48.0
Slightly Satisfied 13.1 10.2 16.3 14.7
Slightly Dissatisfied 0.0 2.0 1.0 5.3
Dissatisfied 1.0 0.0 2.0 0.0
Extremely Dissatisfied 0.0 0.0 1.0 0.0
Total Extremely Satisfied or Satisfied 85.9 87.8 79.6 80.0
12.Secondary Outcome
Title Patient Satisfaction Evaluation
Hide Description Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months
Time Frame 3, 6, 9, and 12 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.
Arm/Group Title 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 99 98 98 75
Measure Type: Number
Unit of Measure: percentage of participants
Extrememly Satisfied 33.3 29.6 25.5 30.7
Satisfied 44.4 45.9 44.9 40.0
Slightly Satisfied 14.1 15.3 21.4 17.3
Slightly Dissatisfied 6.1 4.1 2.0 4.0
Dissatisfied 1.0 5.1 3.1 6.7
Extremely Dissatisfied 1.0 0.0 3.1 1.3
Total Extremely Satisfied or Satisfied 77.8 75.5 70.4 70.6
13.Secondary Outcome
Title Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Hide Description Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months
Time Frame 3, 6, 9, and 12 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.
Arm/Group Title 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 99 98 98 75
Measure Type: Number
Unit of Measure: percentage of participants
Extrememly Likely 29.3 34.7 28.6 36.0
Likely 36.4 31.6 36.7 33.3
Somewhat Likely 14.1 19.4 17.4 16.0
Somewhat Unlikely 13.1 7.1 7.1 4.0
Unlikely 5.1 3.1 7.1 5.3
Extremely Unlikely 2.0 4.1 3.1 5.3
Total Extremely Likely or Likely 65.7 66.3 65.3 69.3
14.Secondary Outcome
Title Mean Hand Function Rating During Prior Week
Hide Description

Effectiveness was measured by evaluating subject's hand function during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Questions were as follows and were graded by subject as 1 = very good, 2 = good, 3 = fair, 4 = poor, and 5 = very poor:

  1. Overall, how well did you hand work?
  2. How well did your fingers move?
  3. How well did your wrist move?
  4. How was the strength in your hand?
  5. How was the sensation (feeling) in your hand?
Time Frame Baseline and 3, 6, 9, and 12 months post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 1 subject did not complete questionnaire at 6 months.
Arm/Group Title Baseline, Right Hand: Radiesse Injectable Dermal Filler 3 Months, Right Hand: Radiesse Injectable Dermal Filler 6 Months, Right Hand: Radiesse Injectable Dermal Filler 9 Months, Right Hand: Radiesse Injectable Dermal Filler 12 Months, Right Hand: Radiesse Injectable Dermal Filler Baseline, Left Hand: Radiesse Injectable Dermal Filler 3 Months, Left Hand: Radiesse Injectable Dermal Filler 6 Months, Left Hand: Radiesse Injectable Dermal Filler 9 Months, Left Hand: Radiesse Injectable Dermal Filler 12 Months, Left Hand: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 99 99 97 98 75 99 99 97 98 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
How well did your hand work? 1.21  (0.56) 1.14  (0.43) 1.09  (0.29) 1.06  (0.28) 1.12  (0.37) 1.22  (0.58) 1.17  (0.47) 1.09  (0.29) 1.05  (0.22) 1.13  (0.34)
How well did your fingers move? 1.19  (0.49) 1.13  (0.44) 1.09  (0.29) 1.05  (0.22) 1.09  (0.34) 1.21  (0.56) 1.18  (0.50) 1.08  (0.28) 1.05  (0.22) 1.08  (0.27)
How well did your wrist move? 1.14  (0.38) 1.11  (0.40) 1.08  (0.31) 1.07  (0.36) 1.11  (0.35) 1.14  (0.35) 1.15  (0.46) 1.11  (0.41) 1.05  (0.22) 1.12  (0.33)
How was the strength in your hand? 1.28  (0.64) 1.20  (0.49) 1.15  (0.42) 1.15  (0.44) 1.19  (0.43) 1.43  (0.73) 1.26  (0.56) 1.18  (0.41) 1.15  (0.36) 1.21  (0.44)
How was the sensation in your hand? 1.19  (0.47) 1.20  (0.51) 1.13  (0.34) 1.07  (0.26) 1.18  (0.42) 1.26  (0.63) 1.19  (0.47) 1.15  (0.36) 1.10  (0.30) 1.13  (0.34)
15.Secondary Outcome
Title Difficulty Performing Activities During Prior Week
Hide Description

Effectiveness was measured by evaluating subject's difficulty in performing routine activities during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:

  1. Turn a knob
  2. Pick up a coin
  3. Hold a glass of water
  4. Turn a key in a lock
  5. Hold a frying pan
Time Frame Baseline and 3, 6, 9, and 12 months post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; see previously reported population description. 1 subject did not complete baseline, right hand questionnaire. 2 subjects did not complete baseline, left hand questionnaire.1 subject did not complete 6-month questionnaire for either hand.
Arm/Group Title Baseline, Right Hand: Radiesse Injectable Dermal Filler 3 Months, Right Hand: Radiesse Injectable Dermal Filler 6 Months, Right Hand: Radiesse Injectable Dermal Filler 9 Months, Right Hand: Radiesse Injectable Dermal Filler 12 Months, Right Hand: Radiesse Injectable Dermal Filler Baseline, Left Hand: Radiesse Injectable Dermal Filler 3 Months, Left Hand: Radiesse Injectable Dermal Filler 6 Months, Left Hand: Radiesse Injectable Dermal Filler 9 Months, Left Hand: Radiesse Injectable Dermal Filler 12 Months, Left Hand: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 98 99 97 98 75 97 99 97 98 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
Turn a knob 1.01  (0.10) 1.05  (0.33) 1.02  (0.14) 1.05  (0.42) 1.05  (0.46) 1.08  (0.28) 1.07  (0.38) 1.05  (0) 1.03  (0.17) 1.04  (0.2)
Pick up a coin 1.07  (0.33) 1.12  (0.54) 1.04  (0.25) 1.06  (0.43) 1.05  (0.46) 1.12  (0.39) 1.07  (0.38) 1.05  (0.30) 1.04  (0.20) 1.03  (0.16)
Hold a glass of water 1.03  (0.22) 1.05  (0.33) 1.01  (0.10) 1.04  (0.40) 1.05  (0.46) 1.08  (0.31) 1.06  (0.37) 1.02  (0.14) 1.03  (0.17) 1.03  (0.16)
Turn a key in a lock 1.03  (0.17) 1.09  (0.52) 1.04  (0.25) 1.09  (0.48) 1.08  (0.49) 1.11  (0.35) 1.09  (0.41) 1.06  (0.28) 1.08  (0.28) 1.07  (0.25)
Hold a frying pan 1.08  (0.31) 1.12  (0.54) 1.05  (0.27) 1.12  (0.52) 1.08  (0.49) 1.11  (0.35) 1.09  (0.41) 1.06  (0.28) 1.06  (0.24) 1.07  (0.3)
16.Secondary Outcome
Title Difficulty Performing Activities During Prior Week, Both Hands
Hide Description

Effectiveness was measured by evaluating subject's difficulty in performing routine activities, that require both hands, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:

  1. Open a jar
  2. Button a shirt / blouse
  3. Eat with a knife and fork
  4. Carry a grocery bag
  5. Wash dishes
  6. Wash your hair
  7. Tie shoelaces / knots
Time Frame Baseline and 3, 6, 9, and 12 months post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; see previously reported population description. 1 subject did not complete baseline questionnaire; 1 subject did not complete 6-month questionnaire.
Arm/Group Title Baseline: Radiesse Injectable Dermal Filler 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 98 99 97 98 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
Open a jar 1.20  (0.63) 1.18  (0.58) 1.13  (0.47) 1.11  (0.35) 1.09  (0.37)
Button a shirt / blouse 1.14  (0.45) 1.06  (0.34) 1.05  (0.27) 1.12  (0.39) 1.07  (0.3)
Eat with a knife and fork 1.03  (0.17) 1.04  (0.32) 1.01  (0.10) 1.02  (0.14) 1.00  (0)
Carry a grocery bag 1.12  (0.41) 1.08  (0.40) 1.04  (0.25) 1.04  (0.20) 1.00  (0)
Wash dishes 1.09  (0.38) 1.05  (0.36) 1.01  (0.10) 1.01  (0.10) 1.01  (0.12)
Wash your hair 1.09  (0.35) 1.04  (0.32) 1.01  (0.10) 1.03  (0.22) 1.01  (0.12)
Tie shoelaces / knots 1.08  (0.31) 1.07  (0.38) 1.02  (0.14) 1.03  (0.17) 1.03  (0.23)
17.Secondary Outcome
Title Normal Work During Prior Week Evaluation
Hide Description

Effectiveness was measured by evaluating subject's ability to work normally, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never:

  1. How often were you unable to do your work because of problems with your hand(s) / wrist(s)?
  2. How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)?
  3. How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)?
  4. How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)?
  5. How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)?
Time Frame Baseline and 3, 6, 9, and 12 months post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; see previously reported population description. 1 subject did not complete baseline questionnaire; 1 subject did not complete 6-month questionnaire.
Arm/Group Title Baseline: Radiesse Injectable Dermal Filler 3 Months Post-treatment: Radiesse Injectable Dermal Filler 6 Months Post-treatment: Radiesse Injectable Dermal Filler 9 Months Post-treatment: Radiesse Injectable Dermal Filler 12 Months Post-treatment: Radiesse Injectable Dermal Filler
Hide Arm/Group Description:

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Overall Number of Participants Analyzed 98 99 97 98 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
Unable to do your work? 4.80  (0.81) 4.93  (0.46) 4.88  (0.62) 4.99  (0.10) 4.96  (0.20)
Shorten your work day? 4.79  (0.82) 4.92  (0.49) 4.87  (0.61) 4.97  (0.17) 4.96  (0.20)
Take it easy at your work? 4.73  (0.84) 4.90  (0.50) 4.88  (0.60) 4.93  (0.30) 4.89  (0.42)
Accomplish less in your work? 4.73  (0.84) 4.91  (0.50) 4.88  (0.62) 4.96  (0.20) 4.96  (0.20)
Take longer to do tasks? 4.73  (0.64) 4.88  (0.58) 4.87  (0.62) 4.93  (0.26) 4.89  (0.53)
Time Frame [Not Specified]
Adverse Event Reporting Description Two patients were enrolled and then withdrew prior to treatment, leaving 99 of the original 101 participants (98%).
 
Arm/Group Title Radiesse Injectable Dermal Filler
Hide Arm/Group Description

Device: Radiesse Injectable Dermal Filler

Radiesse Injectable Dermal Filler: Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

All-Cause Mortality
Radiesse Injectable Dermal Filler
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radiesse Injectable Dermal Filler
Affected / at Risk (%)
Total   0/99 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Radiesse Injectable Dermal Filler
Affected / at Risk (%)
Total   7/99 (7.07%) 
Skin and subcutaneous tissue disorders   
Bruising  5/99 (5.05%) 
Swelling  3/99 (3.03%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ashlee Duncan
Organization: Merz North America
Phone: 984-222-6040
Publications:
Busso M,et al. Multi-center Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxlapatite For Hand Rejuvenation. Derm Surg 2010; 36:790-797
Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01004107     History of Changes
Other Study ID Numbers: P0508332
First Submitted: October 27, 2009
First Posted: October 29, 2009
Results First Submitted: October 6, 2016
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018