Trial Outcomes & Findings for Radiesse® Safety Study For the Treatment of Hands (NCT NCT02904096)

NCT ID: NCT02904096

Last Updated: 2020-01-13

Results Overview

Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs.

Recruitment status

COMPLETED

Study phase

Target enrollment

256 participants

Primary outcome timeframe

Month 6

Results posted on

2020-01-13

Participant Flow

The study was conducted at 9 investigational sites in the United States.

A total of 256 subjects were enrolled and treated, out of which 216 subjects completed the study.

Participant milestones

Participant milestones
Measure	Group A: MHGS Grade 4 Hands Group Subjects with Merz hand grading scale (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 percent (%) lidocaine hydrochloric acid (HCL) up to 3 cubic centimeter (cc) (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
Overall Study STARTED	130	126
Overall Study COMPLETED	111	105
Overall Study NOT COMPLETED	19	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: MHGS Grade 4 Hands Group Subjects with Merz hand grading scale (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 percent (%) lidocaine hydrochloric acid (HCL) up to 3 cubic centimeter (cc) (2 syringes) per hand per treatment at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	4	3
Overall Study Lost to Follow-up	10	17
Overall Study Non-compliant	3	1
Overall Study Sponsor instructed	1	0

Baseline Characteristics

Radiesse® Safety Study For the Treatment of Hands

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: MHGS Grade 4 Hands Group n=130 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=126 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.	Total n=256 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants	107 Participants n=7 Participants	178 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants	19 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	118 Participants n=7 Participants	246 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants	118 Participants n=7 Participants	241 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	122 Participants n=5 Participants	117 Participants n=7 Participants	239 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	130 Participants n=5 Participants	126 Participants n=7 Participants	256 Participants n=5 Participants
Fitzpatrick skin type Type I	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Fitzpatrick skin type Type II	63 Participants n=5 Participants	65 Participants n=7 Participants	128 Participants n=5 Participants
Fitzpatrick skin type Type III	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Fitzpatrick skin type Type IV	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Fitzpatrick skin type Type V	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Fitzpatrick skin type Type VI	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: The SES was the subset of all subjects who were exposed to the study device at enrollment.

Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs.

Outcome measures

Outcome measures
Measure	Group A: MHGS Grade 4 Hands Group n=130 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=126 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
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	1.5 percentage of subjects	0 percentage of subjects

SECONDARY outcome

Timeframe: Month 24

Population: The SES was the subset of all subjects who were exposed to the study device at enrollment.

Proportion refers to percentage of subjects with device-and/injection-related severe TEAEs.

Outcome measures

Outcome measures
Measure	Group A: MHGS Grade 4 Hands Group n=130 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=126 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
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	1.5 percentage of subjects	0 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.

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.

Outcome measures

Outcome measures
Measure	Group A: MHGS Grade 4 Hands Group n=112 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=105 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 Change at Month 24, Flexion: Left Hand	4.10 degrees Standard Deviation 10.72	2.07 degrees Standard Deviation 10.88
Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 Change at Month 24, Flexion: Right Hand	4.20 degrees Standard Deviation 10.50	3.17 degrees Standard Deviation 9.16
Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 Change at Month 24, Extension: Left Hand	1.83 degrees Standard Deviation 9.74	-0.32 degrees Standard Deviation 11.88
Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 Change at Month 24, Extension: Right Hand	2.88 degrees Standard Deviation 9.98	0.72 degrees Standard Deviation 13.01

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Group A: MHGS Grade 4 Hands Group n=112 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=105 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
Change From Baseline in Functional Dexterity in Each Hand at Month 24 Change at Month 24: Left Hand	-6.29 seconds Standard Deviation 13.50	-3.76 seconds Standard Deviation 4.82
Change From Baseline in Functional Dexterity in Each Hand at Month 24 Change at Month 24: Right Hand	-4.53 seconds Standard Deviation 7.90	-3.89 seconds Standard Deviation 5.34

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Group A: MHGS Grade 4 Hands Group n=112 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=105 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24 Change at Month 24: Left Hand	-0.52 scores on a scale Standard Deviation 0.60	-0.44 scores on a scale Standard Deviation 0.60
Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24 Change at Month 24: Right Hand	-0.49 scores on a scale Standard Deviation 0.64	-0.52 scores on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Group A: MHGS Grade 4 Hands Group n=112 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=105 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 Change at Month 24,PalmarPinch Strength:Right Hand	0.54 pounds Standard Deviation 3.04	0.40 pounds Standard Deviation 3.04
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 Change at Month 24, Grip Strength: Left Hand	-3.63 pounds Standard Deviation 8.68	-4.65 pounds Standard Deviation 11.17
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 Change at Month 24, Grip Strength: Right Hand	-2.28 pounds Standard Deviation 7.36	-3.37 pounds Standard Deviation 10.85
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 Change at Month 24, Tip Pinch Strength: Left Hand	1.26 pounds Standard Deviation 2.94	1.70 pounds Standard Deviation 3.21
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 Change at Month 24, Tip Pinch Strength: Right Hand	1.60 pounds Standard Deviation 2.99	1.46 pounds Standard Deviation 3.48
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 Change at Month 24, Key Pinch Strength: Left Hand	0.90 pounds Standard Deviation 2.88	1.12 pounds Standard Deviation 2.76
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 Change at Month 24, Key Pinch Strength: Right Hand	1.33 pounds Standard Deviation 2.99	1.26 pounds Standard Deviation 2.99
Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 Change at Month 24,Palmar Pinch Strength:Left Hand	0.68 pounds Standard Deviation 2.78	0.43 pounds Standard Deviation 3.21

SECONDARY outcome

Timeframe: Month 3

Population: The SES was the subset of all subjects who were exposed to the study device at enrollment.

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).

Outcome measures

Outcome measures
Measure	Group A: MHGS Grade 4 Hands Group n=130 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=126 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
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	117 Participants	104 Participants

SECONDARY outcome

Timeframe: Months 9, 15, and 21

Population: Data were not collected and analyzed for this outcome measure due to change in planned analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 3

Population: The SES was the subset of all subjects who were exposed to the study device at enrollment.

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).

Outcome measures

Outcome measures
Measure	Group A: MHGS Grade 4 Hands Group n=130 Participants Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=126 Participants Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment	115 Participants	118 Participants

SECONDARY outcome

Timeframe: Months 9, 15, and 21

Population: Data were not collected and analyzed for this outcome measure due to change in planned analysis.

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).

Outcome measures

Outcome data not reported

Adverse Events

Group A: MHGS Grade 4 Hands Group

Serious events: 9 serious events

Other events: 70 other events

Deaths: 1 deaths

Group B: MHGS Grade 2 or 3 Hands Group

Serious events: 3 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group A: MHGS Grade 4 Hands Group n=130 participants at risk Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=126 participants at risk Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
Cardiac disorders Acute myocardial infarction	1.5% 2/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Congenital, familial and genetic disorders Atrial septal defect	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Eye disorders Blindness unilateral	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Road traffic accident	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.00% 0/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.79% 1/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Nervous system disorders Transient ischaemic attack	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Surgical and medical procedures Hip arthroplasty	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.79% 1/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Surgical and medical procedures Sarcoma excision	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Surgical and medical procedures Shoulder arthroplasty	0.77% 1/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.00% 0/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Surgical and medical procedures Spinal fusion surgery	0.00% 0/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.79% 1/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.

Other adverse events

Other adverse events
Measure	Group A: MHGS Grade 4 Hands Group n=130 participants at risk Subjects 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Months 6, 12, and 18.	Group B: MHGS Grade 2 or 3 Hands Group n=126 participants at risk Subjects with MHGS Grade 2 or 3, which indicates moderate to severe loss of fatty tissue and mild to moderate 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 at Day 0 (Screening or Enrollment). All subjects were treated in the dorsum of the hands. Based on the investigator and subject's decision, subjects received up to three retreatments at Month 6, 12, and 18.
General disorders Injection site bruising	30.0% 39/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	29.4% 37/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
General disorders Nodule	13.1% 17/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	11.1% 14/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
General disorders Pain	8.5% 11/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	7.1% 9/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
General disorders Swelling	24.6% 32/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	21.4% 27/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Skin and subcutaneous tissue disorders Erythema	15.4% 20/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	6.3% 8/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.
Vascular disorders Haematoma	5.4% 7/130 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.	0.79% 1/126 • Baseline up to Month 24 The investigator asked the subject for adverse events (AEs) systematically at each visit.

Additional Information

Public Disclosure Manager

Merz Pharmaceuticals GmbH

Phone: +49 69 1503 1

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
Publication restrictions are in place

Restriction type: OTHER