Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

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

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

Study Overview

• Status: Completed
• Conditions: Aging Hands
• Intervention / Treatment: Device: Radiesse Injectable Dermal Filler

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • Merz Investigative Site #001
  • Munich, Germany
    • Merz Investigative Site #002
  • Munich, Germany
    • Merz Investigative Site #003
  • Munich, Germany
    • Merz Investigative Site #004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merz North America, Inc.

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: October 27, 2009
• First Submitted That Met QC Criteria: October 28, 2009
• First Posted (Estimate): October 29, 2009

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: P0508332