Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.

Detailed Description
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This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment. 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.

Official Title
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Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

Conditions
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Aging Hands

Intervention / Treatment
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* Device: Radiesse Injectable Dermal Filler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Has right and left hands with a rating of 3 or 4 on the Busso Hand Volume Severity Scale (BHVSS) as determined by the treating physician Signs a written informed consent Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through 12 month follow up Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits 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 used predefined products or treatments on the dorsum of the hand within last 4 weeks or intends to use during study Has had any dermal fillers or surgery in the dorsum of the hand Is a female of child bearing potential and not using medically effective birth control or is pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiesse Injectable Dermal Filler<br>Device: Radiesse Injectable Dermal Filler | Device: Radiesse Injectable Dermal Filler<br>* Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier<br>|
| Active Comparator: Delayed Treatment<br>Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months | Device: Radiesse Injectable Dermal Filler<br>* Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand | 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. | 3 months from baseline | 
| ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand | 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. | 3 months from baseline | 
| ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject | 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. | 3 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand | 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. | 3, 6, 9, and 12 months from baseline | 
| ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand | 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. | 3, 6, 9, and 12 months from baseline | 
| ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject | 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. | 3, 6, 9, and 12 months from baseline | 
| Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only | 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. | 3 months from baseline | 
| Global Aesthetic Improvement Scale (GAIS) Ratings of at Least Improved Among the Original Treatment Group Only | Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators | 3 months from baseline | 
| Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand | 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. | 3, 6, 9, and 12 months from baseline | 
| Global Aesthetic Improvement Scale (GAIS) Ratings of at Least Improved Over Study | 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 | 3, 6, 9, and 12 months from baseline | 
| Physician Satisfaction Evaluation | 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 | 3, 6, 9, and 12 months from baseline | 
| Patient Satisfaction Evaluation | Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months | 3, 6, 9, and 12 months from baseline | 
| Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments | Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months | 3, 6, 9, and 12 months from baseline | 
| Mean Hand Function Rating During Prior Week | 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: Overall, how well did you hand work? How well did your fingers move? How well did your wrist move? How was the strength in your hand? How was the sensation (feeling) in your hand? | Baseline and 3, 6, 9, and 12 months post-treatment | 
| Difficulty Performing Activities During Prior Week | 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: Turn a knob Pick up a coin Hold a glass of water Turn a key in a lock Hold a frying pan | Baseline and 3, 6, 9, and 12 months post-treatment | 
| Difficulty Performing Activities During Prior Week, Both Hands | 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: Open a jar Button a shirt / blouse Eat with a knife and fork Carry a grocery bag Wash dishes Wash your hair Tie shoelaces / knots | Baseline and 3, 6, 9, and 12 months post-treatment | 
| Normal Work During Prior Week Evaluation | 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: How often were you unable to do your work because of problems with your hand(s) / wrist(s)? How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)? How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)? How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)? How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)? | Baseline and 3, 6, 9, and 12 months post-treatment |