Evaluation of Radiesse® Dermal Filler for Hand Treatment

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, 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 Treatment

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 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

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 Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl) | Device: Radiesse® Injectable Dermal Filler<br>* Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.<br>|
| Active Comparator: Delayed Treatment<br>Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) 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 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. | 3 months from baseline | 
| ≥ 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. | 3 months from baseline | 
| ≥ 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. | 3 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months from baseline | 
| ≥ 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. | 3 months from baseline | 
| ≥ 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. | 3 months from baseline | 
| 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. | 3 months from baseline | 
| 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 | 3 months from baseline | 
| 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. | 3, 6, 9, and 12 months from baseline | 
| 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. | 3, 6, 9, and 12 months from baseline | 
| ≥ 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. | 3, 6, 9, and 12 months from baseline | 
| ≥ 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. | 3, 6, 9, and 12 months from baseline | 
| 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 | 3, 6, 9, and 12 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aging, hands