Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

Not Applicable

Completed

Conditions: Aging Hands

Interventions: Device: Radiesse Injectable Dermal Filler

Registration Number: NCT01004107

Lead Sponsor: Merz North America, Inc.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Radiesse Injectable Dermal Filler	Radiesse Injectable Dermal Filler	Device: Radiesse Injectable Dermal Filler
Delayed Treatment	Radiesse Injectable Dermal Filler	Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months

Primary Outcome Measures

Name	Time	Method
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), 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 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.
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand	3 months from baseline	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.
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), 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 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.

Secondary Outcome Measures

Name	Time	Method
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand	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 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.
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only	3 months from baseline	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.
Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only	3 months from baseline	Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators
Difficulty Performing Activities During Prior Week, Both Hands	Baseline and 3, 6, 9, and 12 months post-treatment	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
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand	3, 6, 9, and 12 months from baseline	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.
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments	3, 6, 9, and 12 months from baseline	Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months
Normal Work During Prior Week Evaluation	Baseline and 3, 6, 9, and 12 months post-treatment	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)?
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject	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 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.
Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study	3, 6, 9, and 12 months from baseline	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
Patient Satisfaction Evaluation	3, 6, 9, and 12 months from baseline	Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months
Mean Hand Function Rating During Prior Week	Baseline and 3, 6, 9, and 12 months post-treatment	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?
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand	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 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.
Physician Satisfaction Evaluation	3, 6, 9, and 12 months from baseline	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
Difficulty Performing Activities During Prior Week	Baseline and 3, 6, 9, and 12 months post-treatment	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

Trial Locations

Locations (4): Merz Investigative Site #003
🇩🇪
Munich, Germany
Merz Investigative Site #004
🇩🇪
Munich, Germany
Merz Investigative Site #002
🇩🇪
Munich, Germany
Merz Investigative Site #001
🇩🇪
Munich, Germany