NCT02949921

Radiological Evaluation of Radiesse Implantation in the Hands

Completed NA Results posted Last updated 29 November 2023

What this trial tests

NA trial testing Radiesse injectable implant and 2% lidocaine HCL in Volume Loss in the Dorsum of the Hand in 20 participants. Completed in 2 January 2018.

Timeline

1 December 2015

Primary endpoint
2 January 2018

2 January 2018

Quick facts

Lead sponsor	Merz North America, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 December 2015
Primary completion	2 January 2018
Estimated completion	2 January 2018
Sites	1 location across United States

Drugs / interventions tested

• Radiesse injectable implant and 2% lidocaine HCL

Conditions studied

• Volume Loss in the Dorsum of the Hand — all drugs for Volume Loss in the Dorsum of the Hand →

Sponsor

Merz North America, Inc. — full company profile →

Who can join

22 and older, any sex, with Volume Loss in the Dorsum of the Hand. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1 Primary · 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.

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0
Group B: MHGS Grade 2 or 3 Hands Group	0

Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6 Primary · 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.

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0
Group B: MHGS Grade 2 or 3 Hands Group	0

Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24 Primary · 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.

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0
Group B: MHGS Grade 2 or 3 Hands Group	0

Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 Secondary · Months 1 and 6

Month 1

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0
Group B: MHGS Grade 2 or 3 Hands Group	10.0

Month 6

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0
Group B: MHGS Grade 2 or 3 Hands Group	10.0

Michigan Hand Outcomes Questionnaire (MHQ) Scores Secondary · 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-p

Baseline: Left Hand (Function)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	96.5	± 6.69
Group B: MHGS Grade 2 or 3 Hands Group	94.0	± 12.87

Baseline: Left Hand (Pain)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	2.0	± 4.83
Group B: MHGS Grade 2 or 3 Hands Group	4.0	± 8.10

Baseline: Right Hand (Function)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	99.0	± 3.16
Group B: MHGS Grade 2 or 3 Hands Group	96.5	± 6.69

Baseline: Right Hand (Pain)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	1.0	± 2.11
Group B: MHGS Grade 2 or 3 Hands Group	3.5	± 8.18

Month 1: Left Hand (Function)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	99.5	± 1.58
Group B: MHGS Grade 2 or 3 Hands Group	98.5	± 4.74

Month 1: Left Hand (Pain)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	4.5	± 6.43
Group B: MHGS Grade 2 or 3 Hands Group	4.5	± 11.17

Month 1: Right Hand (Function)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	99.5	± 1.58
Group B: MHGS Grade 2 or 3 Hands Group	97.5	± 5.40

Month 1: Right Hand (Pain)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	2.0	± 3.50
Group B: MHGS Grade 2 or 3 Hands Group	4.5	± 9.56

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 Secondary · 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

Month 1

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	10
Group B: MHGS Grade 2 or 3 Hands Group	10

Month 6

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	8
Group B: MHGS Grade 2 or 3 Hands Group	9

Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 Secondary · 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

Month 7

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	7
Group B: MHGS Grade 2 or 3 Hands Group	4

Month 12

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	5
Group B: MHGS Grade 2 or 3 Hands Group	3

Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 Secondary · 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).

Month 1: Left hand (very much improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	60.0
Group B: MHGS Grade 2 or 3 Hands Group	60.0

Month 1: Right hand (very much improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	60.0
Group B: MHGS Grade 2 or 3 Hands Group	60.0

Month 1: Left hand (much improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	10.0
Group B: MHGS Grade 2 or 3 Hands Group	40.0

Month 1: Right hand (much improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	10.0
Group B: MHGS Grade 2 or 3 Hands Group	40.0

Month 1: Left hand (improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	30.0
Group B: MHGS Grade 2 or 3 Hands Group	0.0

Month 1: Right hand (improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	30.0
Group B: MHGS Grade 2 or 3 Hands Group	0.0

Month 1: Left hand (no change)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0.0
Group B: MHGS Grade 2 or 3 Hands Group	0.0

Month 1: Right hand (no change)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0.0
Group B: MHGS Grade 2 or 3 Hands Group	0.0

Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 Secondary · 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).

Month 7: Left hand (very much improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	57.1
Group B: MHGS Grade 2 or 3 Hands Group	75.0

Month 7: Right hand (very much improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	57.1
Group B: MHGS Grade 2 or 3 Hands Group	75.0

Month 7: Left hand (much improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	28.6
Group B: MHGS Grade 2 or 3 Hands Group	0.0

Month 7: Right hand (much improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	28.6
Group B: MHGS Grade 2 or 3 Hands Group	0.0

Month 7: Left hand (improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	14.3
Group B: MHGS Grade 2 or 3 Hands Group	25.0

Month 7: Right hand (improved)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	14.3
Group B: MHGS Grade 2 or 3 Hands Group	25.0

Month 7: Left hand (no change)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0.0
Group B: MHGS Grade 2 or 3 Hands Group	0.0

Month 7: Right hand (no change)

Group	Value	95% CI
Group A: MHGS Grade 4 Hands Group	0.0
Group B: MHGS Grade 2 or 3 Hands Group	0.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Month 24. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A: MHGS Grade 4 Hands Group

Serious: 0/10 (0%)

Deaths: 0/10

Group B: MHGS Grade 2 or 3 Hands Group

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (16 terms — click to expand)

Reaction	System	Group A: MHGS Grade 4 Hand…	Group B: MHGS Grade 2 or 3…
Swelling	General disorders	—	—
Nodule	General disorders	—	—
Pain	General disorders	—	—
Herpes zoster	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Animal scratch	Injury, poisoning and procedural complications	—	—
Contusion	Injury, poisoning and procedural complications	—	—
Fibula fracture	Injury, poisoning and procedural complications	—	—
Limb injury	Injury, poisoning and procedural complications	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Synovial cyst	Musculoskeletal and connective tissue disorders	—	—
Dental implantation	Surgical and medical procedures	—	—
Oral surgery	Surgical and medical procedures	—	—
Rotator cuff repair	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT02949921 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.