N/A
Completed N=256
Radiesse® Safety Study For the Treatment of Hands
Volume Loss in the Dorsum of the Hand
Source: ClinicalTrials.gov NCT02904096 ↗
Enrolled (actual)
256
Serious AEs
4.7%
Results posted
Jan 2020
Primary outcomePrimary: 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; 0 percentage of subjects
Summary
The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 0 | — |
| SECONDARY 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; 0 | — |
| SECONDARY Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24 |
4.10; 2.07; 4.20; 3.17; 1.83; -0.32 | <.001 sig |
| SECONDARY Change From Baseline in Functional Dexterity in Each Hand at Month 24 |
-6.29; -3.76; -4.53; -3.89 | <.001 sig |
| SECONDARY Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24 |
-0.52; -0.44; -0.49; -0.52 | <.001 sig |
| SECONDARY Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24 |
-3.63; -4.65; -2.28; -3.37; 1.26; 1.70 | <.001 sig |
| SECONDARY 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; 104 | — |
| SECONDARY Number of Subjects With MHGS >=1-point Improvement Following 3 Months After Retreatment at Months 9, 15 and 21 |
— | — |
| SECONDARY Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment |
115; 118 | — |
| SECONDARY Number of Subjects With Any Improvement on GAIS Following 3 Months After Retreatment at Months 9, 15 and 21 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator.
- Is at least 22 years of age.
- Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.
Exclusion Criteria
- Was a participant in the Radiesse hands pre-market clinical study
- Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
- Has any medical condition with the potential to interfere with the study or increase the risk of AEs.
Data sourced from ClinicalTrials.gov (NCT02904096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.