Volume Loss in the Dorsum of the HandNCT02904096
Radiesse® Safety Study For the Treatment of Hands
A study testing Radiesse injectable implant and 2% lidocaine HCL in people with Volume Loss in the Dorsum of the Hand, run by Merz North America, Inc. at 9 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volume Loss in the Dorsum of the Hand
- What is being tested?
- Radiesse injectable implant and 2% lidocaine HCL
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Jun 2016to 9 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator.
- Is at least 22 years of age.
- Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.
Who cannot join
- Was a participant in the Radiesse hands pre-market clinical study
- Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
- Has any medical condition with the potential to interfere with the study or increase the risk of AEs.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Merz Investigative Site #0010322
Austin, Texas
Merz Investigative Site #0010405
New York, New York
Merz Investigative Site #0010406
New York, New York
Merz Investigative Site #0010125
Plano, Texas
Merz Investigative Site #0010393
Sacramento, California
Merz Investigative Site #0010321
San Diego, California
Merz Investigative Site #0010392
Spokane, Washington
Merz Investigative Site #0010358
Vista, California
Merz Investigative Site #0010099
West Hollywood, California
About this study
Official title: Radiesse® Post Approval Safety Study For the Treatment of Hands With Moderate to Very Severe Dorsal Volume Loss
The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.
Read the detailed description
This is a 2-year post approval safety (PAS) study evaluating the Adverse Event (AE) rate of Merz Hand Grading Scale (MHGS) baseline grade 4 hands (Group A) compared to the AE rate of MHGS baseline grade 2-3 hands (Group B).
Subjects will be recruited at each site with the intention to have an equal number of subjects in Group A and Group B. All subjects will receive an initial Radiesse hand treatment in both hands, and up to 3 retreatments in the study. Hands will be assessed by evaluators on the MHGS who will be blinded to group, treatment details, time since last treatment, and number of retreatments.
- Conditions
- Volume Loss in the Dorsum of the Hand
- Being tested
- Radiesse injectable implant and 2% lidocaine HCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiesse injectable implant and 2% lidocaine HCLDevice
Radiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand.
| Study group | Role | What they receive |
|---|---|---|
| "Grade 4 Hands" group | Experimental | "Grade 4 Hands" group will be subjects with hand grading of grade 4 (very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand). "Grade 4 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 4 Hands" group can have up to three retreatments over an 18 month period. Receives: Device: Radiesse injectable implant and 2% lidocaine HCL |
| "Grade 2 or 3 Hands" group | Experimental | "Grade 2 or 3 Hands" group will be subjects with hand grading of grade 2 or grade 3 (moderate to severe loss of fatty tissue, mild to moderate visibility of veins and tendons in the dorsal hand). "Grade 2 or 3 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 2 or 3 Hands" group can have up to three retreatments over an 18 month period. Receives: Device: Radiesse injectable implant and 2% lidocaine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Device-and/or Injection-related Severe Treatment-emergent Adverse Events (TEAEs) in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 6
Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs.
Measured: Month 6
Secondary outcomes (9)
Proportion of Subjects With Device-and/Injection-related Severe TEAEs in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 24
Proportion refers to percentage of subjects with device-and/injection-related severe TEAEs.
Measured: Month 24
Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24
The ROM was assessed using a Jamar finger goniometer. This test passively and actively measured the angle of motion of all five metacarpophalangeal joints in each hand right and left by determining the flexion and extension angles. The flexion determined how far each finger could be flexed at the metacarpophalangeal joint toward the palm. The extension determined how each finger could be extended at the metacarpophalangeal joint away from the palm. Degree scale ranges from 0 to 180 degree. Lower values in flexion angle and extension angle means more deterioration in hand function.
Measured: Baseline, Month 24
Change From Baseline in Functional Dexterity in Each Hand at Month 24
The functional dexterity test (FDT) assessed the fine motor skills (dexterity) that means it assessed the subject's ability to use the hand for daily tasks requiring the 3-jaw chunk prehensions that is buttoning, tying shoelaces, screwing a nut and bolt, and lacing yarn using a 16-hole peg board. Functional Dexterity was measured by noting the time in seconds on stopwatch for a hand to invert pegs on a 16-hole pegboard and this test assessed the ability to use hand for daily tasks. Longer times to complete the functional dexterity test means deterioration in hand function.
Measured: Baseline, Month 24
Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24
Sensation in the dorsum of each hand was conducted using a Semmes-Weinstein monofilament touch test. This was assessed using an index finger touch protocol, where by study subject was asked to report when a 2 to 3 centimeter (cm) light touch is felt at 3 different areas of the dorsum of each hand. Sensation results were coded for analysis such as response to 2.83 filament = 1, response to 3.61 filament = 2, response to 4.31 filament = 3, response to 4.56 filament = 4, response to 6.65 filament = 5, and no response to either filament = 6. For sensation testing a value of 1 (response to 2.83 filament) is considered normal while a value of 2 (response to 3.61) would show diminished light touch. Score ranges from 1 to 6. A higher value in sensation measurements is associated with a deterioration in hand function.
Measured: Baseline, Month 24
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24
Hand strength was assessed in two ways grip and pinch strengths. Grip strength was assessed using a standard, adjustable-handle Jamar hydraulic hand dynamometer. Pinch strength was assessed in three different ways such as tip (two-point) pinch, key (lateral) pinch, and palmar (three-jaw chuck) pinch using the Jamar hydraulic pinch gauge. Lower values (pounds) in hand grip and pinch strength are associated with deterioration in function.
Measured: Baseline, Month 24
Number of Subjects With MHGS Scores Greater Than or Equal (>=) to 1-point Improvement From Baseline in Both Hands at Month 3 After Initial Treatment
The MHGS was used to measure clinical effectiveness of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made at a single, live rating at a specific study time point. A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score. MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons).
Measured: Month 3
Number of Subjects With MHGS >=1-point Improvement Following 3 Months After Retreatment at Months 9, 15 and 21
The MHGS was used to measure clinical effectiveness of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made at a single, live rating at a specific study time point. A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score. MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons).
Measured: Months 9, 15, and 21
Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment
The GAIS is a 7-point scale. The 7-point scale are as follow: +3 (very much improved), +2 (much improve), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).
Measured: Month 3
Number of Subjects With Any Improvement on GAIS Following 3 Months After Retreatment at Months 9, 15 and 21
The GAIS is a 7-point scale. The 7-point scale are as follow: +3 (very much improved), +2 (much improve), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).
Measured: Months 9, 15, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start10 Jun 2016
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Volume Loss in the Dorsum of the HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904096
- Sponsor's protocol ID
- P151009, M900311002
- Status last verified
- Jan 2019
- First submitted
- 13 Sep 2016
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiesse® Post Approval Safety Study For the Treatment of Hands With Moderate to Very Severe Dorsal Volume Loss
- ClinicalTrials.gov ID
- NCT02904096
- Acronym / sponsor ID
- P151009, M900311002
- Conditions
- Volume Loss in the Dorsum of the Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.
Detailed description
This is a 2-year post approval safety (PAS) study evaluating the Adverse Event (AE) rate of Merz Hand Grading Scale (MHGS) baseline grade 4 hands (Group A) compared to the AE rate of MHGS baseline grade 2-3 hands (Group B).
Subjects will be recruited at each site with the intention to have an equal number of subjects in Group A and Group B. All subjects will receive an initial Radiesse hand treatment in both hands, and up to 3 retreatments in the study. Hands will be assessed by evaluators on the MHGS who will be blinded to group, treatment details, time since last treatment, and number of retreatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Grade 4 Hands" group | Experimental | Device: Radiesse injectable implant and 2% lidocaine HCL"Grade 4 Hands" group will be subjects with hand grading of grade 4 (very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand). "Grade 4 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 4 Hands" group can have up to three retreatments over an 18 month period. |
| "Grade 2 or 3 Hands" group | Experimental | Device: Radiesse injectable implant and 2% lidocaine HCL"Grade 2 or 3 Hands" group will be subjects with hand grading of grade 2 or grade 3 (moderate to severe loss of fatty tissue, mild to moderate visibility of veins and tendons in the dorsal hand). "Grade 2 or 3 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 2 or 3 Hands" group can have up to three retreatments over an 18 month period. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator.
- Is at least 22 years of age.
- Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.
Key exclusion criteria (3 listed)
- Was a participant in the Radiesse hands pre-market clinical study
- Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
- Has any medical condition with the potential to interfere with the study or increase the risk of AEs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiesse injectable implant and 2% lidocaine HCLRadiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand. | Device | "Grade 2 or 3 Hands" group, "Grade 4 Hands" group |
Primary outcome
Proportion of Subjects With Device-and/or Injection-related Severe Treatment-emergent Adverse Events (TEAEs) in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 6
Time frame: Month 6
Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs.
9 secondary outcomes
Proportion of Subjects With Device-and/Injection-related Severe TEAEs in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 24
Time frame: Month 24
Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24
Time frame: Baseline, Month 24
Change From Baseline in Functional Dexterity in Each Hand at Month 24
Time frame: Baseline, Month 24
Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24
Time frame: Baseline, Month 24
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24
Time frame: Baseline, Month 24
Number of Subjects With MHGS Scores Greater Than or Equal (>=) to 1-point Improvement From Baseline in Both Hands at Month 3 After Initial Treatment
Time frame: Month 3
Number of Subjects With MHGS >=1-point Improvement Following 3 Months After Retreatment at Months 9, 15 and 21
Time frame: Months 9, 15, and 21
Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment
Time frame: Month 3
Number of Subjects With Any Improvement on GAIS Following 3 Months After Retreatment at Months 9, 15 and 21
Time frame: Months 9, 15, and 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz North America, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiesse injectable implant and 2% lidocaine HCL in people with Volume Loss in the Dorsum of the Hand, run by Merz North America, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With Device-and/or Injection-related Severe Treatment-emergent Adverse Events (TEAEs) in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.