Trial Outcomes & Findings for Radiological Evaluation of Radiesse Implantation in the Hands (NCT NCT02949921)

Last Updated: 2023-11-29

Results Overview

Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Month 1

Results posted on

2023-11-29

Participant Flow

The study was conducted at 1 investigative site in the United States.

A total of 20 participants were enrolled, treated, and completed the study.

Participant milestones

Participant milestones
Measure	Group A: MHGS Grade 4 Hands Group Participants 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 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.	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.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiological Evaluation of Radiesse Implantation in the Hands

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Month 1

Population: All participants who were enrolled in the study.

Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

Outcome measures

Outcome measures
Measure	Group B: MHGS Grade 2 or 3 Hands Group n=10 Participants 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.	Group A: MHGS Grade 4 Hands Group n=10 Participants 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.
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1	0 participants	0 participants

PRIMARY outcome

Timeframe: Month 6

Population: All participants who were enrolled in the study.

Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

Outcome measures

Outcome measures
Measure	Group B: MHGS Grade 2 or 3 Hands Group n=10 Participants 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.	Group A: MHGS Grade 4 Hands Group n=10 Participants 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.
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6	0 participants	0 participants

PRIMARY outcome

Timeframe: 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.

Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 24

Population: Participants who received 4 treatments in total (initial and 3 retreatments).

Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

Outcome measures

Outcome measures
Measure	Group B: MHGS Grade 2 or 3 Hands Group n=2 Participants 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.	Group A: MHGS Grade 4 Hands Group n=4 Participants 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.
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24	0 participants	0 participants

SECONDARY outcome

Timeframe: Months 1 and 6

Population: All participants who were enrolled in the study.

Outcome measures

Outcome measures
Measure	Group B: MHGS Grade 2 or 3 Hands Group n=10 Participants 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.	Group A: MHGS Grade 4 Hands Group n=10 Participants 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.
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	0 percentage of participants
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	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group B: MHGS Grade 2 or 3 Hands Group n=10 Participants 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.	Group A: MHGS Grade 4 Hands Group n=10 Participants 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.
Michigan Hand Outcomes Questionnaire (MHQ) Scores Baseline: Left Hand (Function)	94.0 units on a scale Standard Deviation 12.87	96.5 units on a scale Standard Deviation 6.69
Michigan Hand Outcomes Questionnaire (MHQ) Scores Baseline: Left Hand (Pain)	4.0 units on a scale Standard Deviation 8.10	2.0 units on a scale Standard Deviation 4.83
Michigan Hand Outcomes Questionnaire (MHQ) Scores Baseline: Right Hand (Function)	96.5 units on a scale Standard Deviation 6.69	99.0 units on a scale Standard Deviation 3.16
Michigan Hand Outcomes Questionnaire (MHQ) Scores Baseline: Right Hand (Pain)	3.5 units on a scale Standard Deviation 8.18	1.0 units on a scale Standard Deviation 2.11
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 1: Left Hand (Function)	98.5 units on a scale Standard Deviation 4.74	99.5 units on a scale Standard Deviation 1.58
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 1: Left Hand (Pain)	4.5 units on a scale Standard Deviation 11.17	4.5 units on a scale Standard Deviation 6.43
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 1: Right Hand (Function)	97.5 units on a scale Standard Deviation 5.40	99.5 units on a scale Standard Deviation 1.58
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 1: Right Hand (Pain)	4.5 units on a scale Standard Deviation 9.56	2.0 units on a scale Standard Deviation 3.50
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 6: Left Hand (Function)	100.0 units on a scale Standard Deviation 0.00	98.5 units on a scale Standard Deviation 4.74
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 6: Left Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.5 units on a scale Standard Deviation 1.58
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 6: Right Hand (Function)	100.0 units on a scale Standard Deviation 0.00	100.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 6: Right Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 7: Left Hand (Function)	100.0 units on a scale Standard Deviation 0.00	99.3 units on a scale Standard Deviation 1.89
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 7: Left Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 7: Right Hand (Function)	100.0 units on a scale Standard Deviation 0.00	100.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 7: Right Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 12: Left Hand (Function)	98.0 units on a scale Standard Deviation 6.32	99.0 units on a scale Standard Deviation 3.16
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 12: Left Hand (Pain)	1.5 units on a scale Standard Deviation 4.74	0.5 units on a scale Standard Deviation 1.58
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 12: Right Hand (Function)	98.0 units on a scale Standard Deviation 6.32	100.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 12: Right Hand (Pain)	4.5 units on a scale Standard Deviation 14.23	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 13: Left Hand (Function)	100.0 units on a scale Standard Deviation 0.00	99.4 units on a scale Standard Deviation 1.77
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 13: Left Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.6 units on a scale Standard Deviation 1.77
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 13: Right Hand (Function)	100.0 units on a scale Standard Deviation 0.00	100.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 13: Right Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 18: Left Hand (Function)	100.0 units on a scale Standard Deviation 0.00	99.5 units on a scale Standard Deviation 1.58
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 18: Left Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.5 units on a scale Standard Deviation 1.58
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 18: Right Hand (Function)	100.0 units on a scale Standard Deviation 0.00	100.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 18: Right Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 19: Left Hand (Function)	100.0 units on a scale Standard Deviation 0.00	99.3 units on a scale Standard Deviation 1.89
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 19: Left Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 19: Right Hand (Function)	100.0 units on a scale Standard Deviation 0.00	100.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 19: Right Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 24: Left Hand (Function)	100.0 units on a scale Standard Deviation 0.00	99.5 units on a scale Standard Deviation 1.58
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 24: Left Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 24: Right Hand (Function)	100.0 units on a scale Standard Deviation 0.00	100.0 units on a scale Standard Deviation 0.00
Michigan Hand Outcomes Questionnaire (MHQ) Scores Month 24: Right Hand (Pain)	0.0 units on a scale Standard Deviation 0.00	1.0 units on a scale Standard Deviation 3.16

SECONDARY outcome

Timeframe: Months 1 and 6

Population: All participants who were enrolled in the study.

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).

Outcome measures

Outcome measures
Measure	Group B: MHGS Grade 2 or 3 Hands Group n=10 Participants 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.	Group A: MHGS Grade 4 Hands Group n=10 Participants 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.
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	10 participants
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	8 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group B: MHGS Grade 2 or 3 Hands Group n=4 Participants 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.	Group A: MHGS Grade 4 Hands Group n=7 Participants 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.
Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 Month 7	4 participants	7 participants
Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 Month 12	3 participants	5 participants

SECONDARY outcome

Timeframe: Months 1 and 6

Population: All participants who were enrolled in the study.

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).

Outcome measures

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Group B: MHGS Grade 2 or 3 Hands Group n=4 Participants 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.	Group A: MHGS Grade 4 Hands Group n=7 Participants 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.
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	57.1 percentage of participants
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	57.1 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Left hand (much improved)	0.0 percentage of participants	28.6 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Right hand (much improved)	0.0 percentage of participants	28.6 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Left hand (improved)	25.0 percentage of participants	14.3 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Right hand (improved)	25.0 percentage of participants	14.3 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Left hand (no change)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Right hand (no change)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Left hand (worse)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Right hand (worse)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Left hand (much worse)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 7: Right hand (much worse)	0.0 percentage of participants	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	28.6 percentage of participants
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	28.6 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Left hand (much improved)	50.0 percentage of participants	14.3 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Right hand (much improved)	50.0 percentage of participants	14.3 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Left hand (improved)	0.0 percentage of participants	42.9 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Right hand (improved)	0.0 percentage of participants	42.9 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Left hand (no change)	25.0 percentage of participants	14.3 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Right hand (no change)	25.0 percentage of participants	14.3 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Left hand (worse)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Right hand (worse)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Left hand (much worse)	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Month 12: Right hand (much worse)	0.0 percentage of participants	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants

Adverse Events

Group A: MHGS Grade 4 Hands Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Group B: MHGS Grade 2 or 3 Hands Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	Group A: MHGS Grade 4 Hands Group n=10 Participants 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.	Group B: MHGS Grade 2 or 3 Hands Group n=10 Participants 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.	Total n=20 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 7.40 • n=5 Participants	53.3 years STANDARD_DEVIATION 9.83 • n=7 Participants	57.5 years STANDARD_DEVIATION 9.48 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	10 Participants n=7 Participants	19 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Fitzpatrick Skin Type Skin Type I	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type II	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type III	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type IV	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type V	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type VI	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

Measure	Group B: MHGS Grade 2 or 3 Hands Group n=10 Participants 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.	Group A: MHGS Grade 4 Hands Group n=10 Participants 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.
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	60.0 percentage of participants
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	60.0 percentage of participants
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	10.0 percentage of participants
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	10.0 percentage of participants
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	30.0 percentage of participants
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	30.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	20.0 percentage of participants
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	20.0 percentage of participants
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	20.0 percentage of participants
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	20.0 percentage of participants
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	50.0 percentage of participants
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	50.0 percentage of participants
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	10.0 percentage of participants
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	10.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants
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	0.0 percentage of participants

Measure	Group A: MHGS Grade 4 Hands Group n=10 participants at risk 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.	Group B: MHGS Grade 2 or 3 Hands Group n=10 participants at risk 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.
General disorders Nodule	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
General disorders Pain	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
General disorders Swelling	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	30.0% 3/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Infections and infestations Herpes zoster	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Animal scratch	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Contusion	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Limb injury	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Musculoskeletal and connective tissue disorders Synovial cyst	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Surgical and medical procedures Dental implantation	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Surgical and medical procedures Oral surgery	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.
Surgical and medical procedures Rotator cuff repair	10.0% 1/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.	0.00% 0/10 • Baseline up to Month 24 The investigator asked the participant for adverse events (AEs) systematically at each visit.