Volume Loss in the Dorsum of the Hand
Conditions
Brief summary
The objective of this study is to provide a preliminary assessment of the radiographic appearance of Radiesse material that has been injected into the dorsum of the hands.
Detailed description
Radiesse dermal filler is radiopaque and shows no overt radiographic safety concerns in a study of 58 patients after facial implantation, with Radiesse not always visible on plain X-rays. This Post Approval Safety study will evaluate if there are concerns after Radiesse implantation in the dorsum of hands, specifically if implantation interferes with radiological assessment by obscuring the bones of the hand. Hands will be scored according to the 5 point Merz Hand Grading Scale (MHGS), which ranges from 0 (No loss of fatty tissue) to 4 (Very severe loss of fatty tissue; marked visibility of veins and tendons).
Interventions
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.
Sponsors
Merz North America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Has hands rating 2, 3, or 4 on the validated Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator. 2. Is at least 22 years of age. 3. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.
Exclusion criteria
1. Was a participant in the Radiesse hands pre-market clinical study. 2. Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands. 3. Has any medical condition with the potential to interfere with the study or increase the risk of adverse events (AEs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1 | Month 1 | Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones. |
| Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6 | Month 6 | Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones. |
| Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12 | Month 12 | Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones. |
| Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24 | Month 24 | Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Months 1 and 6 | The GAIS is a 7-point scale. The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse). |
| Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 | Months 1 and 6 | — |
| Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Months 7 and 12 | The GAIS is a 7-point scale. The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse). |
| Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24 | The MHQ is a hand-specific outcomes instrument that measures outcomes of participants with conditions of, or injury to, the hand or wrist. The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics and satisfaction. For this study, MHQ overall hand function and MHQ pain domains were evaluated. Scores for both scales range from 0-100. Higher MHQ hand function scores denote better hand performance whereas higher MHQ pain scores denote more pain. MHQ minimal clinically important differences were defined as score changes greater than an 11-point increase for the pain domain and greater than a 13-point decrease for the function domain. |
| Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6 | Months 1 and 6 | The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made based on a snap-shot 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). |
| Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 | Months 7 and 12 | The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made based on a snap-shot 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). |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 1 investigative site in the United States.
Pre-assignment details
A total of 20 participants were enrolled, treated, and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Group A: MHGS Grade 4 Hands Group Participants with MHGS Grade 4, which indicates very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18. | 10 |
| Group B: MHGS Grade 2 or 3 Hands Group Participants with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue, mild to moderately visibility of veins and tendons in the dorsal hand, received Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment on Day 7 (Week 1). All participants were treated in the dorsum of the hands. Based on the investigator and participant's decision, participants received up to three retreatments at Months 6, 12, and 18. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Group B: MHGS Grade 2 or 3 Hands Group | Total | Group A: MHGS Grade 4 Hands Group |
|---|---|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 9.83 | 57.5 years STANDARD_DEVIATION 9.48 | 61.6 years STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 18 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Skin Type I | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Skin Type II | 4 Participants | 10 Participants | 6 Participants |
| Fitzpatrick Skin Type Skin Type III | 6 Participants | 9 Participants | 3 Participants |
| Fitzpatrick Skin Type Skin Type IV | 0 Participants | 1 Participants | 1 Participants |
| Fitzpatrick Skin Type Skin Type V | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Skin Type VI | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 19 Participants | 9 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 6 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1
Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
Time frame: Month 1
Population: All participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1 | 0 participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1 | 0 participants |
Primary
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12
Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
Time frame: Month 12
Population: Data was not calculated since no participant had bone obscuration at Month 6, and therefore no x-ray was taken at Month 12.
Primary
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24
Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
Time frame: Month 24
Population: Participants who received 4 treatments in total (initial and 3 retreatments).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24 | 0 participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24 | 0 participants |
Primary
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6
Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
Time frame: Month 6
Population: All participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6 | 0 participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6 | 0 participants |
Secondary
Michigan Hand Outcomes Questionnaire (MHQ) Scores
The MHQ is a hand-specific outcomes instrument that measures outcomes of participants with conditions of, or injury to, the hand or wrist. The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics and satisfaction. For this study, MHQ overall hand function and MHQ pain domains were evaluated. Scores for both scales range from 0-100. Higher MHQ hand function scores denote better hand performance whereas higher MHQ pain scores denote more pain. MHQ minimal clinically important differences were defined as score changes greater than an 11-point increase for the pain domain and greater than a 13-point decrease for the function domain.
Time frame: Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24
Population: All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline: Left Hand (Function) | 96.5 units on a scale | Standard Deviation 6.69 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline: Right Hand (Function) | 99.0 units on a scale | Standard Deviation 3.16 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline: Right Hand (Pain) | 1.0 units on a scale | Standard Deviation 2.11 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 1: Left Hand (Function) | 99.5 units on a scale | Standard Deviation 1.58 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 1: Left Hand (Pain) | 4.5 units on a scale | Standard Deviation 6.43 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 1: Right Hand (Function) | 99.5 units on a scale | Standard Deviation 1.58 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 1: Right Hand (Pain) | 2.0 units on a scale | Standard Deviation 3.5 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 6: Left Hand (Function) | 98.5 units on a scale | Standard Deviation 4.74 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 6: Left Hand (Pain) | 0.5 units on a scale | Standard Deviation 1.58 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 6: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 6: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 7: Left Hand (Function) | 99.3 units on a scale | Standard Deviation 1.89 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 7: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 7: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 7: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 12: Left Hand (Function) | 99.0 units on a scale | Standard Deviation 3.16 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 12: Left Hand (Pain) | 0.5 units on a scale | Standard Deviation 1.58 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 12: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 12: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 13: Left Hand (Function) | 99.4 units on a scale | Standard Deviation 1.77 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 13: Left Hand (Pain) | 0.6 units on a scale | Standard Deviation 1.77 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 13: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 13: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 18: Left Hand (Function) | 99.5 units on a scale | Standard Deviation 1.58 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 18: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 18: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 19: Left Hand (Function) | 99.3 units on a scale | Standard Deviation 1.89 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 19: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 19: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 24: Left Hand (Function) | 99.5 units on a scale | Standard Deviation 1.58 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 24: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 24: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 24: Right Hand (Pain) | 1.0 units on a scale | Standard Deviation 3.16 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline: Left Hand (Pain) | 2.0 units on a scale | Standard Deviation 4.83 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 18: Left Hand (Pain) | 0.5 units on a scale | Standard Deviation 1.58 |
| Group A: MHGS Grade 4 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 19: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 19: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline: Left Hand (Function) | 94.0 units on a scale | Standard Deviation 12.87 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline: Left Hand (Pain) | 4.0 units on a scale | Standard Deviation 8.1 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 12: Right Hand (Pain) | 4.5 units on a scale | Standard Deviation 14.23 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline: Right Hand (Function) | 96.5 units on a scale | Standard Deviation 6.69 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 24: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Baseline: Right Hand (Pain) | 3.5 units on a scale | Standard Deviation 8.18 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 13: Left Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 1: Left Hand (Function) | 98.5 units on a scale | Standard Deviation 4.74 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 19: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 1: Left Hand (Pain) | 4.5 units on a scale | Standard Deviation 11.17 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 13: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 1: Right Hand (Function) | 97.5 units on a scale | Standard Deviation 5.4 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 18: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 1: Right Hand (Pain) | 4.5 units on a scale | Standard Deviation 9.56 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 24: Left Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 6: Left Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 13: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 6: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 7: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 6: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 18: Left Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 6: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 18: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 7: Left Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 24: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 7: Left Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 13: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 18: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 7: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 24: Right Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 12: Left Hand (Function) | 98.0 units on a scale | Standard Deviation 6.32 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 19: Left Hand (Function) | 100.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 12: Left Hand (Pain) | 1.5 units on a scale | Standard Deviation 4.74 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 19: Right Hand (Pain) | 0.0 units on a scale | Standard Deviation 0 |
| Group B: MHGS Grade 2 or 3 Hands Group | Michigan Hand Outcomes Questionnaire (MHQ) Scores | Month 12: Right Hand (Function) | 98.0 units on a scale | Standard Deviation 6.32 |
Secondary
Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12
The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made based on a snap-shot 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).
Time frame: Months 7 and 12
Population: All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 | Month 7 | 7 participants |
| Group A: MHGS Grade 4 Hands Group | Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 | Month 12 | 5 participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 | Month 7 | 4 participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 | Month 12 | 3 participants |
Secondary
Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6
The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made based on a snap-shot 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).
Time frame: Months 1 and 6
Population: All participants who were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6 | Month 1 | 10 participants |
| Group A: MHGS Grade 4 Hands Group | Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6 | Month 6 | 8 participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6 | Month 1 | 10 participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6 | Month 6 | 9 participants |
Secondary
Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6
Time frame: Months 1 and 6
Population: All participants who were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 | Month 6 | 0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 | Month 1 | 0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 | Month 6 | 10.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 | Month 1 | 10.0 percentage of participants |
Secondary
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12
The GAIS is a 7-point scale. The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse).
Time frame: Months 7 and 12
Population: All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (no change) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (very much improved) | 57.1 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (very much improved) | 57.1 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (much improved) | 28.6 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (much improved) | 28.6 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (improved) | 14.3 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (improved) | 14.3 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (very much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (very much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (very much improved) | 28.6 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (very much improved) | 28.6 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (much improved) | 14.3 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (much improved) | 14.3 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (improved) | 42.9 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (improved) | 42.9 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (no change) | 14.3 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (no change) | 14.3 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (very much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (very much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (no change) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (very much improved) | 25.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (no change) | 25.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (very much improved) | 75.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (very much improved) | 25.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (very much improved) | 75.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (very much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (much improved) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (much improved) | 50.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (much improved) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (improved) | 25.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (much improved) | 50.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (improved) | 25.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (no change) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (very much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (no change) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (very much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (improved) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (improved) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Right hand (much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 7: Left hand (very much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Left hand (no change) | 25.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 | Month 12: Right hand (much worse) | 0.0 percentage of participants |
Secondary
Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6
The GAIS is a 7-point scale. The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse).
Time frame: Months 1 and 6
Population: All participants who were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (very much improved) | 20.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (improved) | 30.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (much improved) | 20.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (much improved) | 20.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (very much improved) | 60.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (improved) | 50.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (improved) | 50.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (no change) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (no change) | 10.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (no change) | 10.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (improved) | 30.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (very much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (no change) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (very much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (much improved) | 10.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (very much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (very much improved) | 20.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (very much worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (worse) | 0.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (much improved) | 10.0 percentage of participants |
| Group A: MHGS Grade 4 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (very much improved) | 60.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (much improved) | 40.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (very much improved) | 60.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (very much improved) | 60.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (much improved) | 40.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (improved) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (improved) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (no change) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (no change) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Left hand (very much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 1: Right hand (very much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (very much improved) | 30.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (very much improved) | 30.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (much improved) | 20.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (much improved) | 20.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (improved) | 40.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (improved) | 40.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (no change) | 10.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (no change) | 10.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Left hand (very much worse) | 0.0 percentage of participants |
| Group B: MHGS Grade 2 or 3 Hands Group | Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 | Month 6: Right hand (very much worse) | 0.0 percentage of participants |